Product was distributed to one customer.
MediGel FBZ 4 oz.  The cups are inside a cardboard box with protection barrier for sterility.
19 cases/72x 4 oz. plastic cup with foil lids
One lot of product had sub-potent assay results.
HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands:  (a) Elasto-Gel(TM), SL3000  (b) Elasto-Gel(TM), SL3000LV  (c) Elasto-Gel(TM), SL3001  (d) Elasto-Gel(TM), SL3007  (e) Elasto-Gel(TM), SL3008
Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments.  Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts.
HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands:  (a) Elasto-Gel(TM), CAP610  (b) Elasto-Gel(TM), CAP610LV  (c) Elasto-Gel(TM), CAP613  (d) Elasto-Gel(TM), CAP617  (e) Elasto-Gel(TM), CAP619  (f) Elasto-Gel(TM), CAP619LV  (g) Elasto-Gel(TM), CAP622
HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands:  (a) Elasto-Gel(TM), TM7006  (b) Elasto-Gel(TM), TM7006LV  (c) Elasto-Gel(TM), TM7007  (d) Elasto-Gel(TM), TM7008  (e) Elasto-Gel(TM), TM7008b  (f) Elasto-Gel(TM), TM7009  (g) Elasto-Gel(TM), TM7010  (h) Elasto-Gel(TM), TM7011  (i) Elasto-Gel(TM), TM7012
US Nationwide Distribution in the states to Georgia and Wisconsin.
AQURE, Software version 2.3.0 and 2.3.1    Product Usage:  The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets the user send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.
There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.
PerkinElmer Life and Analytical Sciences, Wallac, OY
Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of :  Belgium, Canada, Denmark, Italy, and United Kingdom.
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version)    Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
All software versions from 1.0 to 1.8 (current software version)
SOMATOM Sensation Cardiac    Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
SOMATOM Sensation Open    Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Emotion 6    Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
SOMATOM Scope Power    Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Sensation 64    Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Emotion (2003)    Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Sensation 40    Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Sensation 16    Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Scope    Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Perspective 16    Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Emotion Duo (2003)    Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Sensation 10    Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Perspective     Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Spirit    Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Emotion 16    Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Hitachi Ltd., Medical System Operations Group
MHI-TM2000 Linear Accelerator System    Product Usage:  MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.
Worldwide Distribution - USA (nationwide) and to the following countries:  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Italy,  Japan,  Norway,  Portugal,  Slovakia,  Slovenia,  South Korea,  Spain,  Switzerland
May produce erroneously low results from specific well sets.
Halo Top Candy Bar Non Dairy    UPC: 858089003517    Target item number: 288-7-173
Shipping container from CA to HI was not held at proper temperature which could cause food items to be contaminated with spoilage organisms or pathogens
All product purchased at  Target store T2780, Honolulu, HI from March 23 through March 27, 2018.
Kidfresh Muy Cheesy Quesadillas 4.2oz    UPC: 810882016057    Target item number: 270-2-955
Simply Balanced Quinoa Spinach Red Pepper Onion Chickpeas 10oz;    UPC: 85239058107    Target item number: 270-0-581
BIRDS EYE 10OZ STMFRSH SWET CORN    UPC: 14500020994    Target item number: 270-0-570
Garden Lites Gluten Free Superfood Veggie Cakes Super Blend 6ct 12oz    UPC: 704863050003    Target item number: 270-5-177
Talenti Chocolate Chip Cookie Dough Gelato 16 oz.    UPC: 816680010136    Target item number: 288-7-3566
MP FRUIT 48OZ MEDIUM STRAW BAN    UPC: 85239272039    Target item number: 270-14-203
Enlightened Movie Night Pint      UPC:  852109331109      Target item number 288-7-1798
Eggo Blueberry Waffles 10ct. 12.3 oz    UPC: 38000006944    Target item number: 270-5-33
SMUCKERS 8OZ UNCR WW PB STRW    UPC: 51500041383    Target item number: 270-2-101
Green Giant Steamers Green Beans & Almonds 7.5oz.    UPC:  20000126296    Target item number 270-0-36
Talenti Hazelnut Chocolate Chip Gelato 16oz.    UPC: 186852000402    Target item number: 288-7-3567
Archer Farms Mushroom Risotto Bites 10ct 7.5oz      UPC:  492700600381    Target item number: 270-6-38
Jimmy Dean Delights Canadian Bacon Honey Wheat Muffin 4ct 18oz    UPC: 77900502422    Target item number: 270-5-227
Halo Top Oatmeal Cookie 1 pt    UPC: 858089003210    Target item number: 288-7-1045
Market Pantry Java Chunk 48oz    UPC: 85239724095    Target item number: 288-7-2409
Ben & Jerry's Non Diary Coconut 7 layer 16 fl oz    UPC: 768406744668    Target item number: 288-7-2060
Halo Top Chocolate Chip Cookie Dough 1 Pint;      UPC:  858089003142    Target item number 288-7-1039
Market Pantry Chocolate Ice Cream 128oz    UPC: 85239014950    Target item number: 288-7-308
Green Giant Steamer's Garden Vegetable Medley 8oz.    UPC: 20000163611    Target item number: 270-0-15
Market Pantry Vanilla Ice Cream 128oz    UPC: 85239014943    Target item number: 288-7-307
Ben & Jerry's Pint Slice Tonight Dough    UPC: 768400010028    Target item number: 288-7-2762
SUPERPRETZEL 13OZ SOFT PRETZELS    UPC: 73321073206    Target item number: 270-6-139
MP CARROTS 12OZ CRINKLE CUT CARROT    UPC: 85239004937    Target item number: 270-0-493
MP NOVELTIES 8CT VANILLA CONE    UPC: 85239704318    Target item number: 288-7-431
Yasso Mint Chocolate Chip Pint    UPC: 851035003715    Target item number: 288-7-1613
Grown in Idaho Crispy Crinkle Cut Fries    UPC:  43301611674    Target item number: 270-1-22
22.5OZ MARKET PANTRY HASH BROWN PATTIES    UPC: 85239010792    Target item number: 270-1-79
Enlightened Frozen Hot Cocoa Ice Cream Bar;    UPC:  852109331338    Target item number 288-7-1788
Magnum Tub Dark Chocolate Raspberry 14.8oz    UPC: 775670010092    Target item number: 288-7-2740
Alexia Sweet Potato Julienne Fries 20oz;    UPC:  834183007125    Target item number 270-1-50
Yasso Chocolate Peanut Butter Chip Pint    UPC: 851035003708    Target item number: 288-7-1611
Eggo French Toaster Sticks Original 32ct 12.7oz    UPC: 38000766053    Target item number: 270-5-26
Tail-On Cooked Shrimp - 16oz - Market Pantry    UPC: 85239031353     Target item number: 210-7-264
MP Very Cherry Chocolate Cake Ice Cream 48oz;    UPC:  85239015575    Target item number 288-7-391
COOL WHIP 8 OZ LITE WHIP TOPPING    UPC: 43000009505    Target item number: 288-9-17
Halo Top Oatmeal Cookie Non Dairy Pint    UPC: 858089003470    Target Item Number: 288-7-1675
All product purchased at Target store T2780, Honolulu, HI from March 23 through March 27, 2018.
Amys Thai Red Curry 10oz    UPC:42272009220     Target item number 270-2-162
OLD ORCHARD APPLE JUICE 100% 12OZ    UPC: 75355112418      Target item number: 270-14-81
MP MIX VEG 12OZ MIXED VEG    UPC: 85239004944    Target item number: 270-0-494
Ben & Jerry's Pint Slice Coffee Buzz    UPC: 768400010196    Target item number: 288-7-2763
Enlightened Sea Salt Caramel Ice Cream Bar    UPC: 852109331307    Target item number: 288-7-1787
18oz- EVOL Butternut Squash & Sage Ravioli    UPC: 891627011544    Target item number: 270-11-21
10.8 oz. BIRDS EYE Steamfresh WHOLE GREEN BEANS    UPC: 14500021571    Target item number: 270-0-92
Halo Top Cinnamon Roll Non Dairy Pint    UPC: 858089003463    Target item number: 288-7-1677
MP FRUIT 48OZ LG BAG BLUEBERRIES    UPC: 85239230145    Target item number: 270-14-230
Cream Cheese Stuffed Jalapeno Poppers-19 count Market Pantry    UPC: 85239607138    Target item number: 270-6-713
MP NOVELTIES 12CT KIDS IC BARS    UPC: 85239076101    Target item number: 288-7-2610
Halo Top Peanut Butter Cup Non Dairy Pint    UPC: 858089003487    Target item number: 288-7-1672
Eggo Homestyle Waffles 24ct 29.6oz    UPC: 38000402807    Target item number: 270-5-49
11.25-oz. Market Pantry < Texas>    UPC: 85239101933    Target item number: 270-10-193
Market Pantry Ice Cream Candy Bar 6 pack 12 oz    UPC: 492880701809    Target item number: 288-7-180
Yasso Birthday Cake Pint    UPC: 851035003739    Target item number: 288-7-1614
Halo Top Chocolate Covered Banana    UPC:858089003364    Target item number: 288-7-1665
26OZ MARKET PANTRY THIN CUT FRIES    UPC: 85239011812    Target item number: 270-1-81
12 oz. MP Stir Fry Blend    UPC: 85239002568    Target item number: 270-0-256
Market Pantry Steamed Broccoli Florets 12oz    UPC: 85239008928    Target item number: 270-0-531
Ben & Jerry's Moophoria PB Doughlicioius 1pt    UPC: 76840001439    Target item number: 288-7-1145
GREEN GIANT STEAMERS NIBLETS CORN & BUTTER SAUCE 10OZ.    UPC:  20000001104    Target item number 270-0-212
Lean Cuisine Marketplace Bean and Cheese Enchilada Verde 8oz      UPC:13800955265    Target item number: 270-2-1477
GREEN GIANT STEAMERS BROCCOLI & CHEESE 10OZ.      UPC:20000001807     Target item number 270-0-211
Ben and Jerry's One Love 1 pt.    UPC:76840036745    Target item number: 288-7-170
Eggo Seasonal Waffle Brown Sugar 8ct 11.6oz    UPC: 38000156922    Target item number: 270-5-425
Market Pantry Old Fashion Homemade Vanilla Ice Cream 48oz    UPC:85239015568    Target item number: 288-7-390
MP CORN 12OZ YELLOW WHITE CORN    UPC: 85239005231    Target item number: 270-0-523
PEPPERIDGE F 3LYR CAKE CHOC 19.6OZ    UPC: 51000076236    Target item number: 288-9-227
Market Pantry Roasted Sweet Potato Chunks 12oz    UPC: 85239008942    Target item number: 270-0-542
32oz. Market Pantry Potato Puffs    UPC: 85239014523    Target item number: 270-1-452
Halo Top Rainbow Swirl;    UPC: 858089003401    Target item number: 288-7-1670
MP Unicorn Magic Ice Cream 48 oz.    UPC: 85239015544    Target item number: 288-7-388
MP ICE CREAM 48-OZ. CHOCOLATE    UPC: 85239731161      Target item number: 288-7-3100
Eggo Cinnamon French Toast Sticks 32ct 12.7oz    UPC: 38000766039    Target item number: 270-5-27
BREYERS 1.5QT OREO COOKIE    UPC: 77567224828    Target item number:  288-7-801
Market Pantry Asparagus Spears 12oz    UPC: 85239008850    Target item number: 270-0-511
Ben & Jerry's Coffee Caramel Fudge Non-Dairy Frozen Dessert 16 oz    UPC: 76840580774    Target item number: 288-7-812
Ben & Jerry's Moophoria Choc Milk & Cookies 1pt    UPC: 76840001446    Target item number: 288-7-1154
MorningStar Grillers Original Value Pack 18oz    UPC: 28989100801    Target item number: 270-3-112
32OZ MARKET PANTRY CRINKLE CUT FRIES    UPC: 492700104506    Target item number: 270-1-450
Ben & Jerry's Chocolate Fudge Brownie Non-Dairy Frozen Dessert 16 oz    UPC: 76840580743    Target item number: 288-7-810
Halo Top Vanilla Maple Non Dairy    UPC: 858089003579    Target item number: 288-7-167
Sweet Earth Basil Lasagna 9oz;    UPC: 16741001213    Target item number: 270-2-155
GARDEIN 11OZ CRISPY CHICK N SLIDERS    UPC: 842234001398    Target item number: 270-3-67
BIRDS EYE 10 OZ STM FRSH MIX VEG    UPC: 14500021281    Target item number: 270-0-574
Halo Top Sea Salt Caramel Non Dairy Pint    UPC: 858089003494    Target item number: 288-7-1673
Halo Top Caramel Macchiato Non Dairy Pint    UPC: 858089003432    Target item number: 288-7-1674
GARDEIN 10.5OZ MNDRN CHICKN    UPC: 842234000742    Target item number: 270-3-85
MARKET PANTR 150-200CT. 16OZ CKD TAIL OFF;    UPC:  85239004555    Target item number 210-7-455
MP BROCCOLI 12OZ CUT BROCCOLI    UPC: 85239008805    Target item number: 270-0-488
CW ULTIMATE SOUTHWEST VEG 14OZ    UPC: 70332002881    Target item number: 270-0-4
BREYERS 1.5QT VAN/CHOC/STRW    UPC:77567254269    Target item number: 288-7-784
BREYERS 1.5QT MNT CHOC CHIP;      UPC: 77567254245    Target item number: 288-7-782
InnovAsian Vegetable Fried Rice 18oz    UPC: 695119120147    Target item number: 270-11-249
Ben & Jerry's Pint Slice Cherry Garcia    UPC: 768400010264    Target item number: 288-7-2764
Green Giant Broccoli Veggie Tots 16 oz    UPC:  190569123026    Target item number 270-0-71
10-oz. Bird's Eye Steamfresh cut green beans    UPC: 14500021014    Target item number: 270-0-572
GREEN GIANT STEAMERS BABY BRUSSEL SPROUTS & BUTTER SAUCE 10OZ.    UPC: 20000001401    Target item number  270-0-280
Enlightened Cookies & Cream Pint      UPC:  852109331130      Target item number 288-7-1796
Popsicle Fruit Pop Strawberry 19.8floz - 12ct    UPC: 77567001290    Target item number: 288-7-1146
Sweet Earth Protein Lovers Burrito 6oz.     UPC: 16741201552    Target item number: 270-2-127
Market Pantry Cookies n' Cream Ice Cream 128oz    UPC: 85239014974    Target item number: 288-7-310
Market Pantry Homestyle Waffles 10ct 12.3oz    UPC: 85239260005    Target item number: 270-5-260
Yasso 4ct Mint Greek Frozen Yogurt Bar    UPC: 851035003234    Target item number: 288-7-1762
Grown in Idaho Thick-Cut Hash Browns    UPC: 43301611667    Target item number: 270-1-24
MP 40oz Antioxidant Blend    UPC: 85239273937    Target item number: 270-14-393
BREYERS 1.5QT FRENCH VANILLA    UPC: 77567254382    Target item number: 288-7-790
30OZ MARKET PANTRY SHREDDED HASH BROWN    UPC: 85239454015    Target item number: 270-1-454
Talenti 16oz Coffee Chocolate Chip Gelato    UPC: 186852000495    Target item number: 288-7-598
Breyers Chocolate Peanut Butter Ice Cream 48oz;      UPC:  77567603326    Target item number: Vendor N+J:L
Enlightened Mint Chip Swirl Ice Cream Bar;    UPC:  852109331321    Target item number 288-7-1789
Breyers 48oz Chocolate Reeses Reeses Piece 2 in 1    UPC: 775670009416    Target item number: 288-7-2767
Frozen Desserts market pantry    UPC: 85239015599    Target item number: 288-7-296
Amys Tofu Scramble 9oz    UPC: 42272000548  270-5-102    Target item number
MP PEAS 12OZ SWEET PEAS    UPC: 85239000496    Target item number: 270-0-490.
GARDEIN 9OZ CRISPY TENDERS    UPC: 842234000520    Target code 270-3-82
Amys Spinach Ravioli Bowl 9oz    UPC: 42272011292    Target item number 270-2-416
MP ICE CREAM 48-OZ. COOKIES & CREAM    UPC: 85239731154    Target item number: 288-7-3099
Ben & Jerry's 16 oz. Mint Choc. Cookie    UPC: 768401000400    Target item number: 288-7-127
Halo Top Chocolate Covered Banana Non Dairy Pint    UPC: 858089003456    Target item number: 288-7-1678
MorningStar Spicy Black Bean Buger Value Pack 18.9oz    UPC: 28989100665    Target item number: 270-3-114
MARKET PANTRY MIXED FRUIT BLEND 48 OZ.    UPC: 85239273623    Target item number: 270-14-362
Market Pantry Mini Sundae Cone 10 pack 22.5 oz    UPC: 492880701786    Target item number: 288-7-178
C&W Early Harvest Petite Peas 16OZ.    UPC: 70332001587    Target item number: 270-0-160
Market Pantry Denali Caramel Brownie 48oz    UPC: 85239015551    Target item number: 288-7-389
BREYERS 1.5QT CHOCOLATE    UPC: 77567306623    Target item number: 288-7-779
Market Pantry Seasoned Curly Fries 28oz    UPC: 85239132104    Target item number: 270-1-132
Breyers Delights Raspberry Chocolate 1pt    UPC: 775670011600    Target item number: 288-7-275
Stouffers Macaroni and Cheese 12oz    UPC: 13800103406    Target item number: 270-2-1499
24OZ MARKET PANTRY WAFFLE CUT FRIES    UPC: 85239010808    Target item number: 270-1-80
MP FRUIT 48OZ MEDIUM TRIPLE BRY    UPC: 85239270219    Target item number: 270-14-201
Ben & Jerry's Moophoria Caramel Cookie Fix 1pt    UPC: 76840001415    Target item number: 288-7-1153
MP FRUIT 64OZ LG BAG STRWBRIES;    UPC: 85239231142    Target item number: 270-14-231
MP PREMIUM I 48OZ CHOC FUDG BRWN    UPC: 85239735619    Target item number: 288-7-3561
Magnum Tub Milk Chocolate Hazelnut 14.8oz;    UPC: 775670009898    Target item number: 288-7-2741
AF CRAB CAKE 7OZ CRAB CAKES;    UPC: 85239064658    Target item number: 270-6-465
Simply Balanced Organic Cut Corn 10oz.    UPC: 85239008713    Target item number: 270-0-578
Gardein Ultimate Beefless Ground 13.8oz    UPC: 842234000988    Target item number: 270-3-9
TINA BURRITO 4OZ GRN CHL BEEF/BEAN;    UPC: 79606010355    Target item number: 270-6-526
Ben & Jerry's 16oz Caramel Chocolate Cheesecake    UPC: 768400007158    Target item number: 288-7-2761
COOL WHIP 80Z WHIPPED TOPPING    UPC: 43000009536  288-9-16    Target item number:
SMUCKERS 8OZ UNCRSTBL PBJ STRWB    UPC: 51500025178    Target item number: 270-2-58
Simply Balanced Organic Peas 10oz;    UPC: 85239008706    Target item number: 270-0-577
Simply Balanced 10OZ ORGANIC STRWBRY    UPC: 85239001745    Target item number: 270-14-285
Amys Gluten and Dairy Free Bean Rice Burrito 6oz    UPC: 42272003525  Target item number: 270-2-1391
Amys Light and Lean Pasta Veggies Bowl 8oz  UPC: 42272000654  Target item number 270-2-587
2-ct. (9-oz.) Hot Pockets X Four Cheese Pizza    UPC: 43695071092    Target item number: 270-6-190
Simply Balanced Organic Broccoli Florets 10oz    UPC: 85239008775    Target item number: 270-0-248
Gorton's 8.2oz. Simply Bake Garlic & Butter Salmon    UPC: 44400125086    Target item number: 210-7-198
Halo Top Mochi Green Tea    UPC: 858089003388    Target item number: 288-7-1666
Ben & Jerry's Glampfire Trail Mix 1 pint    UPC: 76840001194    Target item number: 288-7-21
Alexia Waffle Fries Sweet Potato 20oz    UPC: 834183007149    Target item number: 270-1-48
Sweet Earth Bean and Mango Cuban 9oz    UPC: 16741001022     Target item number: 270-2-870
Simply Balanced Organic Mixed Vegetables 10 oz.    UPC: 85239008645    Target item number: 270-0-249
Ben & Jerry's 16oz ND Cinnamon Buns    UPC: 768400006540    Target item number: 288-7-2771
Sea Cuisine Pan Sear Teriyaki Sesame Salmon - 9 oz    UPC: 35493014678    Target item number: 210-7-14
Halo Top S'mores 1 Pint;    UPC: 858089003180    Target item number: 288-7-1042
Ben & Jerry's 16oz Chocolate Shake it    UPC: 76840000739    Target item number: 288-7-2759
denali Ice Cream 48 oz    UPC: 85239007853    Target item number: 288-7-81
Halo Top Caramel Macchiato    UPC: 858089003357    Target item number: 288-7-1669
Ben & Jerry's 16oz ND PB Half Baked    UPC: 768400006618    Target item number: 288-7-2758
Market Pantry Onion Rings 14-oz.    UPC: 85239606179    Target item number: 270-6-617
Green Giant Steamers Healthy Weight Vegetable Blend 7oz.    UPC: 20000197593    Target item number 270-0-52
C&W WHITE CORN 16OZ.    UPC: 70332001020    Target item number: 270-0-161
MP CAULIFLWR 12OZ CAULIFLOWER    UPC: 85239521007    Target item number: 270-0-521
Market Pantry Neapolitan Ice Cream 128oz    UPC: 85239014967    Target item number: 288-7-309
C&W YELLOW & GREEN ZUCHINI SQUASH 16OZ.    UPC: 70332002782    Target item number: 270-0-235
Magnum Tub Milk Chocolate Vanilla 14.8oz    UPC: 775670010238    Target item number: 288-7-2739
MorningStar Farms Buffalo Chik Patties 10oz    UPC: 28989101044    Target item number: 270-3-28
Halo Top Pancakes and Waffles Non Dairy;    UPC: 858089003524    Target item number: 288-7-186
Breyers Delights Creamy Chocolate 16 oz    UPC: 775670006514    Target item number:288-7-1431
Breyers 48oz Oreo Chips Ahoy 2 in 1    UPC: 775670008976    Target item number: 288-7-2765
MP FRUIT 12OZ BLUEBERRIES    UPC: 85239271742    Target item number:  270-14-174
Halo Top Birthday Cake Non Dairy    UPC: 858089003531    Target item number: 288-7-187
MORNINGSTAR MEAT FREE CORN DOGS 10;    UPC: 28989975003    Target item number: 270-3-159
BERTOLLI 24OZ SHRMP SCMPI LING    UPC: 31000650100    Target item number: 270-11-141
Grown in Idaho Crispy Potato Puffs    UPC: 43301611636    Target item number:  270-1-23
Lean Cuisine Favorites Macaroni and Cheese 10oz    UPC: 13800188052    Target item number: 270-2-1277
Market Pantry Blueberry 10ct 12.3oz    UPC: 85239261002    Target item number: 270-5-261
Halo Top Pancakes & Waffles    UPC: 858089003395    Target item number: 288-7-1668
Popsicle Fruit Pop Mango 19.8floz - 12ct    UPC: 77567001283    Target item number: 288-7-1147
Ben & Jerry's 16oz Chillin the Roast it    UPC: 768400007226    Target item number: 288-7-2760
MARKET PANTR 71-90CT CKD TAIL OFF;    UPC:  85239032800  Target item number 210-7-456
Gorton's Simply Bake Shrimp Scampi - 8.2oz    UPC: 44400125604    Target item number: 210-7-80
Earths Best Homestyle French Toast Sticks 12.7oz    UPC: 23923206311	    Target item number: 270-2-50
Halo Top Cookies & Cream 1 pt.    UPC: 858089003135    Target item number: 288-7-1047
Ben & Jerry's Chocolate Cookie PB Swirl Non-Diary Frozen Dessert 16 oz.    UPC: 76840580767    Target item number: 288-7-814
Talenti 16 oz. Black Rasp Choc Chip    UPC: 186852000617    Target item number: 288-7-3281
Halo Top Candy Bar    UPC: 858089003340    Target item number:  288-7-1671
MP ICE CREAM ROCKY ROAD 48OZ    UPC: 85239734179    Target item number: 288-7-3417
Green Giant Cauliflower Veggie Tots 16 oz    UPC: 190569123002    Target item number  270-0-69
Magnum Tub White Chocolate Vanilla 14.8oz    UPC: 77570010166    Target item number: 288-7-2742
Yasso Chocolate Chip Cookie Dough Pint    UPC: 851035003692    Target item number: 288-7-1612
Green Giant Riced Cauliflower and Sweet Potato 12 oz    UPC: 190569123132    Target item number  270-0-75
Halo Top Peanut Butter Cup 1 Pint    UPC: 858089003227    Target item number: 288-7-1041
BEN JERRYS 16OZ FUDGE BROWNIE    UPC: 76840100477    Target item number: 288-7-133
New York Garlic Knots 7.3 oz;    UPC: 70459009305    Target item number: 270-10-2
BREYERS 1.5QT NAT VANILLA IC    UPC: 77567306609    Target item number: 288-7-781
Breyers Delights Mint Chip 16 oz      UPC: 775670006446    Target item number: 288-7-1432
Ben & Jerry's Brownie Batter Core Ice Cream 16 oz    UPC: 76840529872    Target item number: 288-7-804
Halo Top Chocolate Non Dairy Pint    UPC: 858089003449      Target item number: 288-7-1676
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692    The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692      The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692     The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692     The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
FL   and  France  Spain  Sweden  United Kingdom  Germany
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution: US (nationwide) in states of: AL, AR, FL, GA, IN, KY, LA, MO, MS, OH, OK, TX, and VA; and countries of: Canada, Costa Rica and Chile.
Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis     The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis     The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
Ignite High Endurance Pre-Workout Supplement with Caffeine, brand Back to Health, Net wt. 1 lb.  UPC 8 01650 01540 2.    Ignite High Endurance Pre-Workout Supplement with CAFFEINE, brand Muscle Sports & Nutrition (MSN), Net wt. 1 lb. UPC 8 01650 01540 2 and UPC 8 01650 01541 9.
Ignite High Endurance Pre-Workout Supplement with Caffeine dietary supplement product is recalled because label declared WHEY protein but do not declare milk.
Back to Health brand lot #: 1502014, 1503001, 1512022, 1605004, 1105007, and 1711009.    Private label brands: firm did not provide lot codes.
Ignite High Endurance Pre-Workout Supplement, brand Back to Health, Net wt. 1 lb.  UPC 8 01650 01541 9.    Ignite High Endurance Pre-Workout Supplement, brand Healthy Home Center Inc., Net wt. 1 lb. UPC 8 01650 01541 9.    Ignite High Endurance Pre-Workout Supplement, brand Super Natural Quality Health Food Center LLC, Net wt. 1 lb. UPC 8 01650 01540 2.  SAMPLE ONLY.      Ignite High Endurance Pre-Workout Supplement, brand Strike First. Net Wt. No UPC. SAMPLE ONLY.
Ignite High Endurance Pre-Workout Supplement dietary supplement product is recalled because label declared WHEY protein but do not declare milk.
Back to Health and Healthy Home Center brands lot #: 1502014, 1503001, 1512022, 1605004, 1105007, and 1711009.    Private label brands: firm did not provide lot codes.
Enduravol Elite Pre-Workout, brand Clean Athletics.  Net wt. 1 lbs. No UPC.
Enduravol Elite Pre-Workout dietary supplement product is recalled because label declared WHEY protein but do not declare milk.
Ignite High Endurance Pre-Workout Supplement CAFFEINE FREE Formula, brand	Wynant's Familty Health Foods, Net wt. 2.64 lbs. UPC 8 01650 01551 8.  SAMPLE ONLY.
Ignite High Endurance Pre-Workout Supplement Caffeine Free dietary supplement product is recalled because label declared WHEY protein but do not declare milk.
Ignite High Endurance Pre-Workout Supplement VANILLA, brand Back to Health, Net wt. 1 lb.  UPC 8 01650 01540 2 and no UPC    Ignite High Endurance Pre-Workout Supplement VANILLA, brand Body-B-Healthy, net wt. 1 lb. UPC 8 01650 01540 2. SAMPLE ONLY.    Ignite High Endurance Pre-Workout Supplement VANILLA, brand Natures Market, net wt. 1 lb. UPC 8 01650 01541 9. SAMPLE ONLY.    Ignite High Endurance Pre-Workout Supplement VANILLA, brand Alive & Well, net wt. 1 lb. UPC 8 01650 01541 9.    Ignite High Endurance Pre-Workout Supplement Vanilla, brand Muscle Sports & Nutrition (MSN), net wt. 1 lb. UPC 8 01650 01540 2.
Ignite High Endurance Pre-Workout Supplement VANILLA  dietary supplement product is recalled because label declared WHEY protein but do not declare milk.
Back to Health brand codes:   1502014, 1503001, 1512022, 1605004, 1105007, and 1711009.    These two lot numbers may be found on Back to  Health and Alive & Well brands:  1605007 (caffeine) and lot 1603022 (caffeine).    Private label brands: firm did not provide lot codes.
West Area F/4; No. 8 Liye Road; Changping
Beijing Syntech Laser UL Station    surgical lasers
Beijing Syntech Laser APOLLO V+ Medical Platform     surgical lasers
Beijing Syntech Laser Trixel 11 C02 Laser    surgical lasers
Beijing Syntech Laser Nice Station Light Based Platform    surgical lasers
Beijing Syntech Laser Diode Laser    surgical lasers
Beijing Syntech Laser APOLLO JV+ Medical Platform    surgical lasers
Beijing Syntech Laser Trixel C02 Laser     surgical lasers
Beijing Syntech Laser UL C02 Laser    surgical lasers
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers:  a) REF 6561-910C  b) REF 6561-916K  c) REF 6561-920C    To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).
products may be missing a one-way valve on the fluid patient port.
All dietary supplements manufactured and distributed by Riddhi USA Inc.
Per order of the Consent Decree, firm is recalling all dietary supplements.
American Natl. Red Cross-Greater Chesapeake & Potomac Region
Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced
Apheresis products, collected with excess amount of  PAS additive, were distributed.
US  Nationwide, OUS countries: AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DJ, DK, DO, EC, EE, EG, ES, FI, FJ, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IT, JO, KZ, LB, LT, LV, MA, MO, MX, MY, NI, NL, NO, NZ, PE, PH, PK, PL, PR, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TT, TW, UA, UY, XK, ZA
StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
Distributed to accounts in 8 states: CA, FL, NJ, NY, OR, PA, VA, and WI. International distribution to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand.
BD MAX DNA MMK Lab Use, catalog no. 442828
The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Philips Electronics North  America Corporation
Worldwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.      The product was distributed to the following countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Cuba, Czech Republic, Denmark, Estonia, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Republic of Korea, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Caledonia, Norway, Pakistan, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, and United Kingdom.
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system    Product Usage:  The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, eg peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placement, embolization and thrombolysis. Cardiac imaging applications including diagnostics, interventional minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper ED series is compatible with a hybrid operating room.
After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself.
Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47.
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51
Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47.
Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47.
Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-244-47
Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for: AuroMedics Pharma, LLC, NDC 55150-243-46.
Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-52
OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England
Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)
Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Farce Islands, Finland, France, Germany, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Korea, Republic of, Latvia, Lebanon, Luxembourg, Malaysia, Martinique Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
708033 URODiagnost    As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
MultiDim Eleva 708032      As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
MultiDiagnost Eleva 708036    As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
MultiDiagnostic-Eleva with Flat Detector 708038    As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
MultiDiagnostic-Eleva with Flat Detector 708035    As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037     As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Mutlidiagnost-Eleva with Flat Detector 708034    As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Cinnamon Sugar Cookie, Brand name Columbia Gorge Gluten Free.  Packaged in a plastic bag for wholesale purposes.   The product is received frozen and baked in house for individual serving. NO UPC
Cinnamon Sugar Cookie is recalled because the ingredient statement declared milk but the Contains statement declared only Dairy.
Stryker Medical Division of Stryker Corporation
6376 M-1 Cot Fastener, catalog no. 6376000000
The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
6381 M-1 Cot Fastener, catalog no. 6381000000
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45
Failed Dissolution Specification: Low dissolution outside of specifications
Worldwide Distribution - US Nationwide in the states of FL, GA, IN, NJ, and countries of Canada, Austria, Chile, Italy, Singapore
5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840    Product Usage:  The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical instruments and allow for maintenance of pneumoperitoneum. For uninhibited laparoscopic access, the Apple-Hunt Cannula/Trocar provides greater instrument maneuverability while maintaining an airtight seal -with no bulky external valves, fittings, or housings. The ergonomic trocar design is simple to use and features a smooth cannula/trocar transition for easier sleeve insertion and reduced risk of patient injury.
Products have been packaged with the wrong Trocar length type.
Us Nationwide Distribution in the states of:  NY, MD, TX, IL, IN, KY, FL, OH, TN, CA, GA, KS, MO & NC
Miriam Capsule Endoscope System. Model MR1100    Product Usage:  MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.
When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage.
Mitragyna Speciosa Leaf Powder Green Horn Kratom product is  being recalled because they have the potential to be contaminated with Salmonella
Recalled product has any of the following LOT Numbers:    RVS1380182301;  RVB1380182201;  GVH1380171512;  MD13120181601.
Mitragyna Speciosa Leaf Powder Thai Maeng Da Kratom product is being recalled because they have the potential to be contaminated with Salmonella
350 packages of Red Vein Sumatra and 350 packages of Red Vein Bali
Mitragyna Speciosa Leaf Powder Red Vein Sumatra and Mitragyna Speciosa Leaf Powder Red Vein Bali Kratom  products are being recalled because they have the potential to be contaminated with Salmonella
Chocolate Sea Salt Probiotic Granola, Purely Elizabeth, 8oz, PET/LLDPE Pouch, 6 units/case,
Chocolate Sea Salt Probiotic Granola due to undeclared soy lecithin.
Purely Elizabeth Item: 111222 Best By: OCT102017
Shelled Eggs, Extra Large 18pk sold under the brand names of Publix UPC 0 41415 00966 0 & Sunups UPC 0 28621 36398 4
The firm was notified by their supplier that the product may contain Salmonella.
P1539D 048A Best By APR 02 & P1539D 049A Best By APR 03
DLP Marquette General Hospital, LLC - Marquette
Blood product, collected from a donor who received a piercing within one year of donation, was distributed.
Blood products, collected in defective collection bags, were distributed.
Blood and Blood Products for Reprocessing
Blood product, in which donor suitability was not adequately determined, was distributed.
Stuffed FOODS Edamame Burger, MFG ITEM # 06100   UPC: 108500821003752  3 - 3lb plastic bags in box
eataly artichoke spread, net wt. 7oz 200g, UPC 612067
Distributed to the states of OH, NY, FL, MN, and KS.
WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270.    Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Michigan, Minnesota, North Carolina, Ohio, South Carolina, South Dakota, Tennessee, Virginia, Wisconsin, and West Virginia.
Happy Harvest Leaf Spinach; Net Wt. 13.5 oz (383g); Ingredients: Spinach, Water, Salt. Distributed by Aldi Inc. Batavia, IL 60510; Product of USA; Manufactured In A Facility That Processes Peanuts and Soy. May Contain Peanuts and Soy.  Packaged in a steel 2-piece can.
Canned spinach is being recalled due to the potential to contain boiled peanuts instead of spinach.
Lot Code: SPIN71A23IX Use by January 2021;   UPC: 041498131289
American Red Cross Greater Alleghenies Region
Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis products, that failed quality control for residual WBC count, were distributed.
Germany, Federal Republic of; Switzerland
Blood products collected from a donor for whom donor suitability was not adequately determined, were distributed.
Domestic: Unknown, the firm would only provide e-mail addresses    Foreign:None    VA/DOD: None
Protein key brand Protein Meals varieties , 2.5 lb plastic container and 400 g plastic container, Varieties: Sleep/Relax Plain
Wysong Corporation is conducting a voluntary recall of multiple varieties of Protein Key brand protein meals due to undeclared allergen soy.
All varieties come in chocolate and plain flavors, 2.5 lb plastic container and 400 g plastic container.     Products use date code for expiration date MMDDYY, recall indicates all products sent to consumers within expiration period. Lot codes: Lots 042016 - 042018
Protein key brand Protein Meals varieties , 2.5 lb plastic container and 400 g plastic container, Varieties:   Immune Plain
Protein key brand Protein Meals varieties , 2.5 lb plastic container and 400 g plastic container, Varieties:Healthy Weight Chocolate
Protein key brand Protein Meals varieties, 2.5 lb plastic container and 400 g plastic container, Varieties: Bone & Joint Chocolate
Protein key brand Protein Meals varieties , 2.5 lb plastic container and 400 g plastic container), Varieties: Recovery Chocolate
Protein key brand Protein Meals varieties, 2.5 lb plastic container and 400 g plastic container, Varieties: Essentials Plain
Protein key brand Protein Meals varieties , 2.5 lb plastic container and 400 g plastic container, Varieties: Essentials Chocolate
Protein key brand Protein Meals varieties , 2.5 lb plastic container and 400 g plastic container), Varieties: Women's Chocolate
Protein key brand Protein Meals varieties , 2.5 lb plastic container and 400 g plastic container, Varieties: Digestive Plain
Protein key brand Protein Meals varieties, 2.5 lb plastic container and 400 g plastic container, Varieties:   Optimal Nutrition Plain
Protein key brand Protein Meals varieties , 2.5 lb plastic container and 400 g plastic container, Varieties: Diabetes & Metabolic Plain
Protein key brand Protein Meals varieties , 2.5 lb plastic container and 400 g plastic container), Varieties: Women's Plain
Protein key brand Protein Meals varieties, 2.5 lb plastic container and 400 g plastic container), Varieties: -Whole Protein Shake
Protein key brand Protein Meals varieties , 2.5 lb plastic container and 400 g plastic container, Varieties: Anti-Aging Chocolate
Protein key brand Protein Meals varieties , 2.5 lb plastic container and 400 g plastic container, Varieties: Healthy Weight Plain
Protein key brand Protein Meals varieties, 2.5 lb plastic container and 400 g plastic container, Varieties: Immune Chocolate
Protein key brand Protein Meals varieties , 2.5 lb plastic container and 400 g plastic container, Varieties:   Children's Plain
Protein key brand Protein Meals varieties , 2.5 lb plastic container and 400 g plastic container, Varieties:   Digestive Chocolate
Protein key brand Protein Meals varieties, 2.5 lb plastic container and 400 g plastic container, Varieties: Bone & Joint Plain
Protein key brand Protein Meals varieties, 2.5 lb plastic container and 400 g plastic container, Varieties: Anti-Aging Plain
Protein key brand Protein Meals varieties, 2.5 lb plastic container and 400 g plastic container, Varieties: Optimal Nutrition Chocolate
Protein key brand Protein Meals varieties, 2.5 lb plastic container and 400 g plastic container), Varieties: Pregnancy & Nursing Plain
Protein key brand Protein Meals varieties, 2.5 lb plastic container and 400 g plastic container), Varieties: Skin & Hair Plain
Protein key brand Protein Meals varieties , 2.5 lb plastic container and 400 g plastic container), Varieties: Athlete Plain
Protein key brand Protein Meals varieties, 2.5 lb plastic container and 400 g plastic container), Varieties: Pregnancy & Nursing Chocolate
DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502    Product Usage: general surgical
Non-sterile product was packaged inside a case that was labeled as sterile.
American Red Cross Blood Services Southwest Region
Blood product collected from a donor for whom donor suitability was not adequately determined, was distributed.
American National Red Cross (The) - North Central Region
Apheresis products, not meeting product specifications, were distributed.
US Distribution to the states of :  AL, MS, and MA.
, Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04    The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by microbial infections.
A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cGMP) deficiencies including lack of data to support products conform to final specifications, and lack of expiration dates on the product being recalled.
Product does not bear lot codes. All product lacking lot codes and expiration dates is being recalled.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis products for which quality control procedures were not performed, were distributed.
D. D. Eisenhower Army Med. Ctr. -  Blood Bank
Blood product, where transfusion-transmitted infection testing was performed and/or interpreted incorrectly, was distributed.
Worldwide distribution.  US nationwide,  Australia, France, India, Japan, and  Netherlands.
Biograph Horizon - PET/CT, PETsyngo VJ20A Software  Nuclear medicine/ xray diagnostic scanner.
Error introduced into PET images acquired and reconstructed with VJ20A software.  Array values are indexed improperly when the norm file is created during QC. During data reconstruction, incorrect values are being applied. This can lead to a gradient in the image.  The severity of the error is directly related to the positioning of the PET QC phantom relative to the center of the field of view.
Software version VJ20A.  Code No. 10532746, 10532748.
Parade Salsa MEDIUM/MEDIANO NET WT/PESO NETO 24 OZ (1 LB 8 OZ) 680g, UPC: 0 50700 08876 1
1463 cases (17,556 units) - Total for All Products
Parade Salsa MILD/SUAVE NET WT/PESO NETO 24 OZ (1 LB 8 OZ) 680g, UPC: 0 50700 08421 3
Parade Salsa Hot/Picante NET WT/PESO NETO 24 OZ (1 LB 8 OZ) 680g, UPC: 0 50700 08883 9