Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
TASTY DELICIOUS brand Sugar Bun, Net Wt. 227 Grams (8 Ounces), UPC Code 8 59253 0045 7
The product contained undeclared eggs, FD&C Yellow # 5 and FD&C Red # 40 based on sampling and analysis by New York State Department of Agriculture and Markets, plus undeclared milk based on FDA document review.
IQF Cut Green Beans; Net Weight 20 lb; Dist. by JML Ingredients, East Petersburg PA, 17520; Packed by: The International Co. for Agri Production & Processing. - ICAPP; Exporter's Address Industrial Zone A - 2 (Lot W) - 10th of Ramadan City - Egypt.
JML Ingredients, Inc. of East Petersburg, PA is recalling IQF Cut Green Beans, because it has the potential to be contaminated with Listeria monocytogenes
Recalled product was distributed to customers in AR, IA, IL, KS, MA, MO, MS, NH, NY, OK, TN, and VT.
Right Now Gold (C1.4) (MC) MEDICATED, product code 55102-CC, Type C medicated feed packaged in 50lb bags, strength of CTC is 1.4g/lb, most responsible firm name on the label states:  Cargill Animal Nutrition General Office Minneapolis, MN. 55440, www.cargillanimalnutrition.com
Feed was manufactured without the correct amount of chlortetracycline (CTC), difubenzuron, and/or (S)-Methoprene added and some products are subpotent and others are superpotent.
Lot number 6161565754, manufactured on 04JUN16
Appleton City 5 Cow/Stocker MN (C1.4) (MC) MEDICATED, product code 151299-C, Type C medicated feed packaged in 50lb bags, strength of CTC is 1.4g/lb, most responsible firm listed on the label states:  Cargill Animal Nutrition Gneral Office Minneapolis, MN 55440, www.cargillanimalnutrition.com
Lot number 6161655874, manufactured on 13JUN16
FortiGraze 6 (CTC 4800) IGR (MC) MEDICATED, product code 151313-C2, Type C medicated feed packaged in 50lb bags, strength of CTC is 2.4g/lb, label states:  Manufactured For: Livestock Nutrition Center 409 Shepard St. Chickasha, OK 73018
Lot number 6161605810, manufactured on 08JUN16
Cameron 4oz CTC5600 Fescue Mineral MEDICATED, product code 160200_CT, Type C medicated feed packaged in 50lb bags, strength of CTC is 5600g/ton, label states: Custom Mix Not For Resale or Redistribution Consult Cargill Representative For Feeding Directions Manufactured by: Cargill Animal Nutrition General Office Minneapolis, Minn. 55440
Lot number 6161545709, manufactured on 02JUN16
FortiGraze 3 (CTC6000) (MC) MEDICATED, product code 151706-C, Type C medicated feed packaged in 50lb bags, strength of CTC is 3.0g/lb, label states: Manufactured for: Livestock Nutrition Center 409 Shepard St. Chickasha, OK 73018
Lot number 6161335507, manufactured on 12MAY16
Right Now Emerald Anaplas (C2.4) (MC) MEDICATED, product code 55103-C1, Type C medicated feed packaged in 50lb bags, strength of CTC is 2.4g/lb, most responsible firm name on the label states:  Cargill Animal Nutrition General Office Minneapolis, MN. 55440, www.cargillanimalnutrition.com
Lot number 6161545718, manufactured on 02JUN16
Right Now Emerald Fly (C1.4) (MC) MEDICATED, product code 55103-AL, Type C medicated feed packaged in 50lb bags, strength of CTC is 1.4g/lb and strength of S-Methoprene is 95.24g/ton, most responsible firm name on the label is: Cargill Animal Nutrition General Office Minneapolis, MN 55440, www.cargillanimalnutrition.com
Lot number 6161445602, manufactured on 23MAY16
PL06126 Nelson LAC RUM/FLY MEDICATED, product code 160000_NH, Type B medicated feed in bulk, strength of monensin is 205.12g/ton and diflubenzuron is 22.84mg/kg, most responsible firm listed on the label states:  Custom Mix. Not For Resale or Redistribution. Manufactured by: Cargill Animal Nutrition Gneral Office Minneapolis, MN 55440
Lot number 6161655886, manufactured on 13JUN16
Powell 4% Beef Mineral (C2.0/IGR) (MC) MEDICATED, product code 151412-C2, Type C medicated feed packaged in 50lb bags, strength of CTC is 2.0g/lb and strength of S-Methoprene is 95.36g/ton, label states: Manufactured For: Powell Feed & Milling 217 Main Street Green Forest, AR 72638
Lot number 6161585767, manufactured on 06JUN16  Lot number 6161465633, manufactured on 25MAY16
Powell 4% Beef Mineral (C2.0) (MC) MEDICATED, product code 151412-C, Type C medicated feed packaged in 50lb bags, strength of CTC is 2.0g/lb, label states: Manufactured For: Powell Feed & Milling 217 Main Street Green Forest, AR 72638
Lot number 6161465634, manufactured on 25MAY16
Right Now Emerald Anaplas Fly Control (C2.4/METH) (MC) MEDICATED, product code 55103-C4, Type C medicated feed packaged in 50lb bags, strength of CTC is 2.4g/lb and strength of S-Methoprene is 95.24g/ton, most responsible firm name on the label states:  Cargill Animal Nutrition General Office Minneapolis, MN. 55440, www.cargillanimalnutrition.com
Lot number 6161545720, manufactured on 02JUN16  Lot number 6161555748, manufactured on 03JUN16
Cattle Grazers APC Mineral (C2800) (MC) MEDICATED, product code 7144-C, Type C medicated feed packaged in 50lb bags, strength of CTC is 1.4g/lb, most responsible firm name on the label states:  Cargill Animal Nutrition General Office Minneapolis, MN. 55440, www.cargillanimalnutrition.com
EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20
Eye Wash, 4 fl oz (118 mL) bottle, OTC,  Distributed by: United Exchange Corp., 17211 Valley View Ave., Cerritos, CA 90703, Made in Korea, UPC Code: 780707005828
Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC,  Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0536-1083-97
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Worldwide Distribution - (US Nationwide) Internationally to Germany, Greece, Australia, United Kingdom, Switzerland, Italy, Norway, France, Canada, and Malta.
Medtronic SynchroMed II Implantable Drug Infusion System.  This system includes:  Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer,  and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.)     Product  Usage:  The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer
Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System.  Medtronic is updating the Model 8870 software application card (to version AAU01) and the SynchroMed pump labeling to address the priming bolus issue.
software application cards with versions other than AAU01
Domperidone capsules 10 mg, compounded,  dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Product was shipped to the following states: AL, AZ, IA, IL, KS, MN, NE, OH, SD, TX & WI.
Deep River Sour Cream & Onion Krinkle Kettle Chips 2 oz bag UPC 8 50668 00049 8 & 5 oz bag UPC 8 50668 00099 3
The firm is recalling various snack products because they used ingredients received from Valley Milk Product which may be contaminated with Salmonella
NACHO CHEESE TORTILLA CHIPS: Essential Everyday 1 oz bag (Multi-pak) UPC 4 13030 05979; Essential Everyday 1 oz bag UPC 4 13030 59821, 10 oz bag UPC 4 13030 37638 & Market Essential 11.5 oz bag UPC 9 84873 00119
Essential Everyday  1 oz bag (Multi-pak) Best By 11/12/2016 - 4/01/2017  Essential Everyday  1 oz bag Best By 11/12/2016 - 3/10/2017  10 oz bag Best By 11/7/2016 - 3/31/2017  Market Essential  11.5 oz bag Best By 11/15/2016 -0 2/19/2017
Larry The Cable Guy Biscuits & Gravy Thin Potato Chips 3 oz bag UPC 7 67212 62423 & 8 oz bag UPC 7 67212 62461
Larry The Cable Guy Jalapeno' Popper Thin Potato Chips 3 oz bag UPC 7 67212 80656 & 8 oz bag UPC 7 67212 80601
Delish Jalapeno' White Cheddar KETTLE COOKED FLAVORED POTATO CHIPS NET WT 8.5 oz (241g) bag CONTAINS: MILK, UPC 4 49022 83607 5
SPICY NACHO CHEESE TORTILLA CHIPS: Essential Everyday 10 oz bag UPC 0 41303 06389 7 & Market Essential 11.5 oz bag UPC 0 98487 30014 0
Essential Everyday 10 oz bag Best By 11/19/2016 - 3/19/2017  Market Essential 11.5 oz bag Best By 11/11/2016 - 2/19/2017
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed.  In an effort to mitigate a potential risk to patient health, Olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter.
Worldwide distribution-US Nationwide and country of: Canada.
Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories    The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.
1,627 units (769 URF-V2 and 858 URF-V2R)
Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures.  Some of these complaints are associated with tissue trauma, including perforation, and insertion tubes which were stuck inside the patient and had to be surgically removed.
U.S. distribution to the following; CA, NY.    No foreign distribution.
Best By: March 17th 2017, March 18th 2017, March 19th 2017, March 20th 2017
foxy's rocky road less travelled  1 Pint
foxy's salted caramel and english toffee  1 Pint
foxy's uncle mike's double chocolate  1 Pint
foxy's rather thoughtful vanilla  1 Pint
Maquet Datascope Corp - Cardiac Assist Division
CARDIOSAVE Hybrid IABP and CARDIOSAVE  Rescue IABP affected part number is 0998-:XX-0800-XX  Li-Ion Battery affected part number is 0146-00-0097      Product Usage:  The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.
Nationwide in the United States and Mexico
Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.
Marketed without an Approved NDA/ANDA and non-sterility:  NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., North Chicago, IL 60064 --- NDC 0074-3012-07
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
Lots:  1055692, Expiration Date (Frozen) 06/01/2018  1057881, Expiration Date (Frozen) 06/02/2018  1060138, Expiration Date (Frozen) 06/13/2018  1060140, Expiration Date (Frozen) 06/15/2018  1061258, Expiration Date (Frozen) 06/17/2018  1061262, Expiration Date (Frozen) 06/30/2018  1063033, Expiration Date (Frozen) 07/14/2018
Ten (10) retail store chains in NY, PA and MA
DARK PRETZEL 63% CACAO, Chip 'n Dipped Chocolatier, CRISP & SALTY DARK CHOCOLATE PRETZEL, NET WT. 2.9oz 82g, UPC 892470002222
Lot numbers: 1100489, 1100512 & 1100531 are stamped on the back of the packaging box, individual units are unmarked.
DARK ALMOND 63% CACAO, Chip 'n Dipped Chocolatier, DARK SEA SALTED ALMOND, NET WT. 3.0oz 85g, UPC 892470002185
Lot Numbers: 1100519, 1100518, 1100535 & 1100526 are stamped on the back of the packaging box, individual units are unmarked.
86% CACAO DARK, Chip 'n Dipped Chocolatier super smooth 86% DARK CHOCOLATE, NET WT. 2.8oz 79g, UPC 892470002345
Lot Numbers: 1100534, 1100533 & 1100532 are stamped on the back of the packaging box, individual units are unmarked.
DARK CRUNCH Chip 'n Dipped Chocolatier DARK CHOCOLATE CRUNCH, NET WT. 2.9oz 82g, UPC 892470002246
Lot# 1100524, 100506 and 1100483 are stamped on the back of the packaging box, individual units are unmarked.
72% CACAO DARK, Chip 'n Dipped Chocolatier extra dark 72% DARK CHOCOLATE, NET WT. 2.8oz 79g, UPC 89247002338
Lot Numbers: 1100515 & 1100516 are stamped on the back of the packaging box, individual units are unmarked.
MARSHMALLOW SUNDAE, Chip 'n Dipped Chocolatier DARK CHOCOLATE MARSHMALLOW SUNDAE, NET WT. 3.1oz 88g, UPC 892470002611
Lot numbers: 1100498, 1100513, 1100505 & 1100530 are stamped on the back of the packaging box, individual units are unmarked.
63% CACAO DARK Chip 'n Dipped Chocolatier 63% CACAO DARK CHOCOLATE, NET WT. 2.9oz 82g, UPC 892470002161
Lot# 1100501 & 1100536 are stamped on the back of the packaging box, individual units are unmarked.
HOT 63% CACAO, Chip 'n Dipped Chocolatier, HOT DARK CHOCOLATE with HABANERO PEPPER, NET WT. 2.8oz 79g, UPC 892470002581
Lot Number: 1100490 are stamped on the back of the packaging box, individual units are unmarked.
Blood and Blood Products for Reprocessing
Blood product, in which labeling applied to blood unit or product incorrect or missing information, was distributed.
Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
Lot number and expiration date    100183, 5/4/2019
Bayview Breast Pack, part number 009080-2
Custom Venous Kit, part number TVS4024(C
General Plastic Pack, part number PSS2432(A
Lot number and expiration date    95325, 6/18/2019
Bayview Abdominoplasty Pack, part number 009079-1
Lap/Pelviscopy Pack, part number PSS3256(B
Extremity Pack, part number AMS3240  Extremity Pack, part number AMS4764  Extremity Pack, part number AMS4788(A  Extremity Pack, part number PSS1798(A  Extremity Pack, part number PSS1798(A  Extremity Pack, part number PSS1798(A  Extremity Pack, part number PSS1842(A  Extremity Pack, part number PSS1842(A  Extremity Pack, part number PSS1842(A  Extremity Pack, part number PSS1842(A  Extremity Pack, part number PSS2706  Extremity Pack, part number PSS2706  Extremity Pack, part number PSS2706  Extremity Pack, part numbre PSS2706  Extremity Pack, part number PSS2706  Extremity Pack, part number PSS2706  Extremity Pack, part number PSS2706  Extremity Pack, part number PSS2706  Extremity Pack, part number PSS2706  Extremity Pack, part number PSS2706  Extremity Pack, part number PSS2706(A  Extremity Pack, part number PSS2706(A  Extremity Pack, part number PSS2706(A  Extremity Pack, part number PSS2706(A
Lap Gallbladder Pack, part number  AMS3707
Lot number and expiration date    101262, 5/9/2018
Lot number and expiration date    101265, 11/1/2018
Hand Pack, part number AMS3640  Hand Pack, part number AMS4213(A  Hand Pack, part number AMS4311(A  Hand Pack, part number AMS5343  Hand Pack., part number PSS1843(A
Minor Procedure Pack, part number AMS4799
Spine Pack	, part number AMS3753(A  Spine Pack, part number AMS3783(A  Spine Pack, part number AMS3783(B  Spine Pack, part number AMS6472
Lot number and expiration date    98651, 5/30/2017
Lot number and expiration date    101254, 10/14/2019
Laparoscopic Pack, part number AMS2499  Laparoscopic Pack, part number AMS2499(A  Laparoscopic Pack, part number AMS2499(B
Extremity Pack (1344), part number AMS6561
Lot number and expiration date    101250, 10/8/2019
Plastic General Pack, part number AMS4215
Upper Extremity Pack, part number AMS4670  Upper Extremity Pack, part number AMS4670(A
Basic Pack, part number AMS1868(B  Basic Pack, part number AMS2608(A  Basic Pack, part number AMS3861  Basic Pack, part number AMS4309  Basic Pack, part number PSS1833  Basic Pack, part number PSS1833(A  Basic Pack, part number PSS1848(A
Laparotomy Pack, part number 006268-9  Laparotomy Pack, part number AMS4418(A  Laparotomy Pack, part number PSS2190(A
Basic Extended Pack, part number AMS4421(A  Basic Extended Pack, part number AMS4421(B
General Laparoscopy Pack, part number AMS4798  General Laparoscopy Pack, part number AMS4798(A
Eye Tray, part number PSS1834  Eye Tray, part number PSS1834(A
Lot Number and Expiration date    101247, 10/9/2019
Pacemaker Kit, part number AMS4281  Pacemaker Kit, part number AMS4281(A  Pacemaker Kit, part number AMS4281(C  Pacemaker Kit, part number AMS4281(D
Percutaneous Entry Kit, part number TVS4022(D  Percutaneous Entry Kit	, part number TVS4022(E  Percutaneous Entry Kit, part number TVS4022(F
Hand Tray, part number PSS2365(F  Hand Tray, part number PSS2365(G
Lot number and expiration date    95176, 10/20/2019
Orbitofacial Pack, part number AMS5850(A
Lot number and expiration date    98286, 6/5/2019
Minor/General/Ortho Pack, part number PSS3258(B
Lap Minor Pack (1346), part number AMS6566
Lot number and expiration date    101255, 10/8/2019
Lot number and expiration date    96521, 1/31/2018
Hysteroscopy Pack, part number AMS4797  Hysteroscopy Pack, part number AMS4797(A  Hysteroscopy Pack, part number AMS4797(B
Dr Bragg Vein Tray - RX, part number 007912-8
Anterior Cervical Fusion Pack, part number AMS2502(A  Anterior Cervical Fusion Pack, part number AMS2502(C
Extremity Pack-N Brunswick, part number PSS1866(A
Lot number and expiration date    84476, 7/21/2018
Lap Chole Pack (6037)	, part number AMS6567
Lot number and expiration date    101256, 10/14/2019
Open Procedure Pack II, part number RMS1740(A
Dr. Newman Surgical Procedure Pack, part number PSS1689(A
Lot number and expiration date      88547, 1/7/2018
Open Procedure Pack, part number AMS4596  Open Procedure Pack, part number AMS4596(A  Open Procedure Pack, part number AMS4596(B
Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B.
General Plastics Pack, part number 008617-1
Shoulder Arthroscopy Pack, part number AMS2496(A  Shoulder Arthroscopy Pack, part number AMS2496(B  Shoulder Arthroscopy Pack, part number AMS2496(C  Shoulder Arthroscopy Pack, part number AMS2609  Shoulder Arthroscopy Pack, part number AMS3857  Shoulder Arthroscopy Pack, part numbr AMS4766  Shoulder Arthroscopy Pack, part number AMS4766(A  Shoulder Arthroscopy Pack, part number AMS4766(B
Lot number and expiration date      83798, 5/17/2018
Laparoscopy Pack (1184), part number AMS6562
Lot number and expiration date    101251, 8/9/2017
Lot number and expiration date    101253, 10/15/2018
Facial Plastic Pack, part number AMS3327(C
Knee Scope Pack, part number AMS2498(A  Knee Scope Pack, part number AMS2498(B  Knee Scope Pack, part number AMS2498(C
Lot number and expiration date    101277, 10/7/2019
Breast Pack, part number AMS3238(A  Breast Pack, part number AMS4419(A  Breast Pack, part number AMS4419(B  Breast Pack, part number AMS5750  Breast Pack, part number AMS5750(A  Breast Pack, part number AMS6120  Breast Pack, part number PSS1784(B  Breast Pack, part number PSS2272(A
Lot number and expiration date    97553, 4/25/2018
Lot number and expiration date    101490, 10/15/2019
General Pack, part number AMS2967(A  General Pack, part number AMS3239(A  General Pack, part number AMS3709(B  General Pack, part number AMS5341  General Pack, part number AMS5694
Liposuction Pack, part number AMS3323(B  Liposuction Pack, part number AMS5684  Liposuction Pack, part number AMS5699
Custom Pack - with Introducer Kit, part number TVS4011NI(L
Lot number and expiration date    100774, 6/9/2019
ENT Pack, part number AMS3237(A  ENT Pack, part number AMS4214
Lot number and expiration date    101499, 10/13/2019
Breast Augmentation Pack, part number AMS1786(A  Breast Augmentation Pack, part number AMS2790(A  Breast Augmentation Pack, part number AMS3324(B  Breast Augmentation Pack, part number AMS4382  Breast Augmentation Pack, part number AMS4382(A  Breast Augmentation Pack, part number AMS4382(B  Breast Augmentation Pack, part number AMS4392  Breast Augmentation Pack, part number PSS3430
Major Breast Pack, part number AMS3409(B
Reduction Mammoplasty Pack, part number AMS4380  Reduction Mammoplasty Pack, part number AMS4380(B
Morris Hysto Pack, part number PSS3198(A
Total Knee Pack (15710), part number AMS6563
Lot number and expiration date    101282, 6/12/2018
Knee Arthroscopy Pack	, part number AMS2610(A  Knee Arthroscopy Pack, part number AMS3236(A  Knee Arthroscopy Pack, part numbre AMS3860
Minor Pack, part number AMS3782(B  Minor Pack, part number AMS3782(C  Minor Pack, part number CMP1560  Minor Pack, part number PSS3518(B  Minor Pack, part number PSS3541(A
Major Laparotomy Pack - NS, part number AMS4347
Custom Pack, part number AMS4776  Custom Pack, part number AMS4776(A  Custom Pack, part number AMS5643  Custom Pack, part number AMS5643(A  Custom Pack, part number AMS6012  Custom Pack, part number AMS6383  Custom Pack, part number PSS2135(B  Custom Pack, part number PSS2798(B  Custom Pack, part number PSS2798(C  Custom Pack, part number PSS3463
Basic Setup Pack, part number AMS1787(A  Basic Setup Pack, part number AMS6519
Custom Breast Augmentation Pack, part number PSS2455(D
Arthroscopy Pack, part number AMS2938  Arthroscopy Pack, part number AMS3639  Arthroscopy Pack, part number AMS4765  Arthroscopy Pack, part number PSS1799  Arthroscopy Pack, part number PSS1845(A
Newport Coast Basic Pack, part number 007484-1
Lumbar Laminectomy Pack, part number AMS2501  Lumbar Laminectomy Pack, part number AMS2501(A  Lumbar Laminectomy Pack, part number AMS2501(B
Lot number and expiration date    100105, 6/21/2019
Lower Extremity Pack, part number AMS4669
General Surgery Pack, part number PSS1380(A
Plastic Surgery Pack, part number AMS5685
Vascular Pack, part number AMS4030  Vascular Pack, part number AMS4030(A
Breast Recon Pack, part number AMS5698  Breast Recon Pack, part number AMS5698(A
Ocular Plastic Pack, part number AMS3868(A
Shoulder Pack, part number AMS2936  Shoulder Pack, part number AMS3638  Shoulder Pack, part number AMS3711(B  Shoulder Pack, part numbere AMS4212  Shoulder Pack, part number AMS6460  Shoulder Pack, part numberPSS1852(A
Lot number and expiration date    84376, 5/25/2018
Plastic Pack, part number PSS2462  Plastic Pack, part number PSS3319  Plastic Pack, part number PSS3319(A
Dr. Landi EVLT Pack, part number AMS1483(E  Dr. Landi EVLT Pack, part number AMS1483(E
Podiatry Pack, part number AMS2778  Podiatry Pack, part number AMS2778(A  Podiatry Pack, part number AMS3785(B  Podiatry Pack, part number AMS3785(C  Podiatry Pack, part number AMS4011(A  Podiatry Pack, part number PSS3422(A
Nationwide.  Afghanistan, Albania, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium,  Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark,  Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia,  Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq,  Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Luxembourg, Macedonia,  Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Caledonia, New  Zealand, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal,  Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia,  Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan,  Thailand, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay,  Vatican, Vietnam
Siemens ADVIA Centaur Systems Calibrator A Kits,   Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack)  Cat No. 04800840, SMN 10285905 (6 pack - REF)
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A kit lots ending in 90 with the FT4 assay.  The performance of the FT4 assay when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur CP System is not affected.  Customers may continue to use Calibrator A kit lots ending in 90 for the ADVIA Centaur Systems FT3, T3, T4 and TUp assays.
ADM Polar Bear Flour, Bleached/Enriched, NET WT 50LB
Product sample tested positive for salmonella.
glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Blood products, collected from an ineligible donor, were distributed.
Apheresis Red Blood Cells, Leukocytes Reduced
distributed in Alaska, Idaho, Oregon, and Washington
Bakery Fresh Goodness Carrot Cupcakes sold in 6 ct. 12 ct. and 25 ct. hard plastic container.    Bakery Fresh Goodness Carrot Cupcakes, 6 count package, UPC 41573-27731;  Bakery Fresh Goodness Carrot Cupcakes, 12 count package, UPC 41573-27732;  Bakery Fresh Goodness Carrot Cupcakes, 25 count package, UPC 41573-27733.
Bakery Fresh Goodness Carrot Cupcakes are recalled due to undeclared milk and soy.
Domestic: MI, FL, MA, TX, GA, CO, OH    Firm updated customer list to include out of state customers on 02/09/2017.   Foreign:None  V/A: None
White Chocolate Toffee, 2.2oz pouches, 6oz pouches, 7oz boxes, one pound boxes
Bell Stone Toffee initiated a voluntary recall of all lots of White Chocolate Toffee, Dark Chocolate Toffee, and Toffee Chocolate Bars due to labeling that declared butter as an ingredient but failed to identify the allergen milk was present in products.
All Lots with Best By Dates Between November 18, 2016 and March 18, 2017
Dark Chocolate Toffee, 2.2oz pouches, 6oz pouches, 7oz boxes, one pound boxes
Domestic: AR, CA, CO, FL, GA, IL, IN, KY, LA, MI, MN, MO, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, WI, WV    Foreign: None    VA/DOD: None
EliA Sample Diluent, Article number, 83-1023-01
Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles.  Investigation showed problems with the liquid level detection in diluent bottle batch JJCA resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate.
EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C
Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Mislabeling.   The packaging labeled as left mandible contained a right mandible.
Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to Canada, Armenia, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Spain, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Kenya, Kuwait, Lithuania, Mauritius, Netherlands, Norway, Oman, Poland, Reunion, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom    VA/DOD: Yes
Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch.  Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch.  Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch.  Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.
TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch.  The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interventions. This device is also intended for injection of radiopaque contrast media for the purpose of angiography.
Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch.  Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Worldwide Distribution - US (nationwide) and internationally to  Argentina, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Canada, Chile, China, Columbia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macau, Malaysia, Mexico, Moldova, Montenegro, Netherlands, New Zealand, Nigeria, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Republic and Venezuela.
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061.  The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips
The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.
Product was shipped to the following states: AK, ID, OR & WA.
Fred Meyer 100% Whole Wheat Bread 16 oz plastic bag  DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 10294 2
During an internal investigationi at the manufacturing facility the firm discovered that hte product may contain undeclared undeclared milk.
Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43
Failed  Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, NDC 45802-806-01, UPC 3 45802-806-01 7.
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Allegan, MI 49010, NDC 45802-237-01,   UPC 3 45802-237-01 9.
US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, and TX.
DR Systems Unity PACS software, now known as Merge Unity PACS.    Product Usage:  Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
28 sites potentially have the affected software
The software is not adding the correct tomo image.
US: WY, TX,  VA, UT, ID, WA, OR, CA, OH, PA
The product also contains the following dietary ingredients that are missing from the label: molybdenum, pancreatin, diastase, papain, ox bile, vanadium, silicon, boron and bromelain.
all lots, Latest Lot 6800919 and 0780919
CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery.   Part numbers 03.820.350 and 03.820.352.  Used to hold the disc segment open and facilitate discectomy
These items are incorrectly etched and labeled.  The item etched and labeled as 10mm Strut 03.820.350 lot 5919005 is a 12 mm Strut.  The item etched and labeled as 12 mm Strut 03.820.352 lot 5919006 is a 10 mm Strut.
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and  WY  and to the countries of : AU, BE, IN, KR, SG,
BD  AffirM VPIII Microbial Identification Test
BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.
HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health  Deer Park, NY 11729
70,176 bottles; 9,000,000 tablets (bulk)
cGMP deviations - presence of rubber particles found loose in the bulk product.
Lot # 6K28817, Exp 10/19 (Packaged in bottle), 10/17 (Bulk)
Pepper Jack Cheese Half Moons, 15pkgs/case UPC 78279600895
Papa John's Salad and Produce is voluntarily recalling half-moon cheese products due to possible Listeria monocytogenes contamination.
Co-Jack Cheese Half Moons, 15pkgs/case UPC 78279600897
Colby Cheese Half Moons, 15pkgs/case UPC 78279600898
Monterey Jack Cheese Half Moons, 15pkgs/case UPC 78279600896
AK, CA, FL, HI, KY, MD, MI, MS, NH, OH, PA, TN, TX, VT
McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
Snak King is recalling cashew clusters because it may be contaminated with Salmonella.
Lot 5352533:  Date code on bag 8/30/17  Lot 5353827: Date code on bag 8/31/17  Lot 5354506: Date code on bag 8/31/17  Lot 5355694: Date code on bag 9/1/17  Lot 5355670: Date code on bag 9/1/17  Lot 5356902: Date code on bag 9/2/17
Worldwide Distribution - US Nationwide in the states of CA, NC and TX; and the countries of Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay.
SONNET Mini Battery Pack CableProduct Usage:  The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.
Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.
Organic IQF Dark Sweet Cherries, 900 cartons per lot
Sunrise Growers is recalling organic IQF Dark Sweet Cherries due to possible Listeria monocytogenes contamination.
Blood products collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, collected in a manner with a potential for air contamination, were distributed.
Blood Bank Of San Bernardino And Riverside Counties
Blood products, incorrectly labeled as having an extended expiration date, were distributed.
Sharp Cheddar Cheese Seasoning, #125121, Net Weight 50 lbs. bags
Gamay was notified by ingredient supplier that the milk powder ingredient was being recalled due to concerns about potential contamination with Salmonella.
Original Cheddar Cheese Seasoning, #117059, Net Weight 1600 lbs. bulk tote
Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count  cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090  India, NDC 55111-135-81
Failed dissolution specifications - low dissolution  results at S3 stage.
Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count  cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090  India, NDC 55111-136-81
Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count  cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090  India,NDC 55111-137-81
Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count  cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090  India, NDC 5511-113-81
Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, Gujarat, India, NDC 47335-956-88.
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.