The product was distributed to the following states: VA, TN.    There are no government accounts for this recall.    There are no Canada accounts for this recall.    There are no Mexico accounts for this recall.
Ultralyx Nutritional Supplement 24% + 3% Mag Composite Block For Beef Cattle on Pasture, 200 lb. plastic tubs
Cattle deaths due to elevated levels of non-protein nitrogen.
Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Supplied Directions for Use (DFU) did not contain a recommended service interval.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREY-MIA16.
Bearing Sleeve, 15CM Straight Taper    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-15ST.
eMax2 Hybrid Hand Control    Product Usage:  Electric system
All product shipped prior to 09/27/2016; DFU 18-0085;   Part No. eMax2-HC.
Bearing Sleeve, 19CM Straight Taper    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-19ST.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-P.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-MRA-L.
IMRI SHORT HD ATTACHMENT    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0093; Part No. IMRI-SHORT-HD.
Sagittal Saw    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MM-SAGITTAL.
Console, eMax2 Plus    Product Usage:  Electric system
All product shipped prior to 09/27/2016;   DFU 18-0085; Part No. SC2100.
B-SAGITTAL ASSEMBLY    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-SAGITTAL.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD11-S.
Minimal Access Attachment, BLACK MAX    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-D20BM.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-BLUE-S.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREY-ADG.
Foot Control, SC2100    Product Usage:  Electric system
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. EPLUS-FP.
Electronic Foot Control with Direction or Irrigation Switches    Product Usage:  Electric system
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-FP
All serial numbers shipped to customers; DFU 18-0062; Part No. B-MRA-S.
BLACKMAX-NEURO LOW PRESSURE    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016;   DFU 18-0040; Part No. BLACKMAX-N-LP
All product shipped prior to 09/27/2016;   DFU 18-0085; Part No. E-FP-DIR/RR
Otologic Curved Micro    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0100; Part No. OCM.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD8.
Autolube-III with 20ft hose    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016;   DFU 18-0040; Part No. AUTOLUBE-III-20
11.0cm Long Attachment    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG.
45 degree Contra Angle Attachment    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0030; Part No. ORANGE-45.
XMAX Motor (Pneumatic Drill System)    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016;   DFU 18-0040; Part No. xMAX.
11cm QD Angle Attachment    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD11.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-ORANGE-90.
Minimal Access Attachment    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-D21.
eMax2 PLUS    Product Usage:  Electric system
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. EMAX2PLUS.
Adult Craniotome    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. Crani-A.
8.0cm Medium Attachment    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MEDIUM.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0097; Part No. CSR60BM.
Autolube-III with Foot Guard    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016;   DFU 18-0040; Part No. AUTOLUBE-III-FG
All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD11.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. SHORT.
14cm QD Angle Attachment    Product Usage:  Product attachment
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD14.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. R-SAW.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD8.
14cm QD Angle Attachment    Product Usage:  Pneumatic system
10.5cm QD Angle Attachment    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD11-S.
Bearing Sleeve, 10CM Curved    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-10C.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREEN.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-BLACK.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. SHORT-HD.
Foot control irrigation system    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016;   DFU 18-0040; Part No. AL-III-IRR
Keyless Driver  Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. DRIVER.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-RED.
Bearing Sleeve, 15CM Straight    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-15S.
Bearing Sleeve, 15CM Curved    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-15C.
Bearing Sleeve, 10CM Straight    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-10S.
20.2cm Heavy Duty Long Heavy Short Attachment
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. XL-HD.
Electronic Foot Control with Direction Switch    Product Usage:  Electric system
All product shipped prior to 09/27/2016;   DFU 18-0085; Part No. E-FP-DIR.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. C-SYSTEM.
90 degree Contra Angle Attachment    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0030; Part No. ORANGE-90.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-L-R.
Rotating Adult Craniotome    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-A-R.
All serial numbers shipped to customers; DFU 18-0095; Part No. BM-DRIVER.
8.2CM ATTACHMENT, BLACK MAX    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-Violet.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. S-SAW.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. SA-JACOBS.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD14-S.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD14-S.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD14.
6.5CM ADLT CRANI, THIN FT PLATE    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-A-01.
Oscillating MICRO-SAW    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. O-SAW.
XMAX Motor, High Strength Hose    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016; DFU 18-0040; Part No. xMAX-H. Device Listing No. D015777.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-ORANGE-45.
10.5cm Long Attachment, Non-Tapered End    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-01.
PEDIATRIC CRANIOTOME, BM    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-TURQ-X.
System Console, Single Port, with irrigation    Product Usage:  Electric system
All product shipped prior to 09/27/2016;   DFU 18-0085; Part No. SC2101.
Minimal Access Straight Driver    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-Driver.
6.1CM ATTACHMENT, BLACK MAX    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-SILVER.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-GOLD.
Autolube-III with NK    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016;   DFU 18-0040; Part No. AUTOLUBE-III-NK
7.2cm Adjustable Drill Guide    Product Usage:  Electric system
All serial numbers shipped to customers; DFU 18-0048; Part No. ADG.
eMax2 Motor Assembly    Product Usage:  Electric system
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. eMax2.
IMRI SHORT ATTACHMENT    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0093; Part No. IMRI-SHORT.
Electric Handpiece EM Hand Control    Product Usage:  Electric system
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-HC.
IMRI AIR CONTROL    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016;   DFU 18-0093; Part No. IMRI-FOOT-CTRL
Autolube-III with Irrigation    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-IRR
12.4cm Heavy Duty Long Heavy Short Attachment    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-HD.
10.5cm Long Attachment    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-S.
AL-III W/ male disconnect and 30ft hose    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016;   DFU 18-0040  Part No. AL-III-DISS-30
All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREEN-R.
System Console, Single Port, no irrigation
All product shipped prior to 09/27/2016;   DFU 18-0085; Part No. SC2102.
Large Craniotome    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-L.
AL-III-DISS Adapter    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016;   DFU 18-0040; Part No. AUTOLUBE-III-DISS
IMRI CRANI-A ATTACHMENT    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0093; Part No. IMRI-CRANI-A.
5.9CM ATTACHMENT, BLACK MAX    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-TURQUOISE.
IMRI MOTOR    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016;   DFU 18-0093; Part No. IMRI-MOTOR
All serial numbers shipped to customers; DFU 18-0062; Part No. B-MRA-M.
8.0CM Heavy Duty Medium Attachment    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MEDIUM-HD.
6.8cm Controlled Depth Attachment    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CDA.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD8-S.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0097; Part No. CSR60.
16cm Minimally Invasive Attachment    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MIA16.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. SA-JLATCH.
Foot Control without Switches, SC2100    Product Usage:  Electric system
All product shipped prior to 09/27/2016;   DFU 18-0085; Part No. EPLUS-FP-NS.
19cm Attachment, Black Max    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016;   DFU 18-0062; Part No. BBLACK
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD8-S.
Autolube-III    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016;   DFU 18-0040; Part No. AUTOLUBE-III
12.6CM TAPERED ATTACHMENT, BLACK MAX    Product Usage:  Pneumatic system
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-TURQ-L.
AL-III W/ male disconnect and 20ft hose    Product Usage:  Pneumatic system
All product shipped prior to 09/27/2016;   DFU 18-0040; Part No. AL-III-DISS-20
Product was distributed to one stable in KY.
Product is suspect of drug contamination.
BD FlowSmart Set MiniMed Pro-set Rx Only   Distributed by Medtronic MiniMed  Inc.  8006464633  8185765555    Legal Manufacturer    Becton, Dickinson and Company   USA     BD Medical-Diabetes Care  Becton Dickinson France SAS
Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked.
MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are  MMT-1510, MMT-1710, MMT-1711, MMT-1712.
Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it leads to battery depletion and pump shutdown.
Olympus ENDOEYE HD II Video Telescopes  Models:  WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable;  WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable;   repair cable 10mm 0/30 deg., part number W7100603
A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.
Methocarbamol Suspension 100 mg/mL Suspension in a 500 mL white plastic bottle. UPC: 12/22/16-12/22/16
Puerto Rico, Dominican Republic, US Virgin Islands, St. Maarten, St. Eustatius, Anguilla, St. Martin, St. Vincent, and Curacao
, GOYA FOODS, INC., Secaucus N.J. 07096.
Product label states name and ingredients as octopus and real content is squid.
Lots: LGOBA31154, LGOBA51153  Manufactured: 7/30/15 and 12/16/15
Lots: LGOJA33153, LGOJA02163  Manufactured: 8/12/15 and 1/13/16
Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
Zimmer Trabecular Metal Technology, Inc.
The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.
This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content.    Information was disseminated to distributors and sales representatives during the 2016 National Sales Meeting held February 17-21, 2016.
Meridian Medical Technologies a Pfizer Company
Nationwide and Puerto Rico, Argentina, Austria, Australia, Belgium, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Japan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Sweden, Switzerland, Taiwan, Thailand,  United Kingdom.  There has been no U.S. government or military distribution.
EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
US:   lot 5GM631, exp. April 2017;  lot 5GM640, exp. May 2017;  lot 6GM072, exp. Sep 2017;  lot 6GM082, exp. Sep 2017;  lot 6GM088, exp. Oct 2017;   lot 6GM087, exp. Oct 2017;   lot 6GM198, exp. Oct 2017;   lot 6GM081, exp. Sep 2017;  lot 6GM091, exp. Oct 2017;  lot 6GM199, exp. Oct 2017:     INTERNATIONAL:  lot 5FA665, exp. April 2017;   lot 5GU763, exp. May 2017;   lot 6FA293, exp. Oct 2017;  lot 6FA292, exp. Oct 2017;  lot 6GH294, exp. Oct 2017.
EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS:  Epipen Auto-Injector Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.
US  lot 5GN767, expiration April 2017;  lot 5GN773, expiration April 2017;  lot 6GN215, expiration Sep 2017:    INTERNATIONAL  lot 5GR765, expiration March 2017;  lot 5GK771, expiration April 2017;  lot 5ED824, expiration April 2017; and   lot 6ED117, expiration ***
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
40/50 ct/kg (21/25 ct/lb) Farm Raised Head-On Shrimps, Keep Frozen, Must be fully cooked before serving.  1.02 kg, 2.24 lb.  Packed by:  Global Marketing Ent Inc, Chicago, IL 60616
Product label for frozen shrimp does not declare the presence of sulfites.
Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents.  Build-up of salt deposits on  unprotected electronic components may combust due to heat generated by electronics when instrument cycles. Completed CAPA identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of the electronic protective shield during manufacturing of the device.
Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
Nationwide, Sweden, Germany, New Zealand, Finland, Australia, Singapore, Korea, Luxembourg, Czech Republic, South Africa, Canada, Switzerland, United Arab Emirates,  Spain, Austria, Hong Kong, Iceland, Japan, Canada, Italy, Ireland, France, United Kingdom
ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology  and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may adversely affect the setup process resulting in an improper cushion setup. Sitting on an over inflated or under inflated Sensor Ready Cushion may reduce or eliminate the benefits provided by the cushion, increasing the risk to skin or to other soft tissue.
US Nationwide in the states of:  AL, AR, AZ, CA, CO, CT, DE, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,  MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV
Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android    Product Usage:  This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice.
A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.
Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android
Product distributed to manufacturers in Illinois, Ohio, and Wisconsin.
Safeguard Flour product code 5122286 packaged in 50 lb bags
Product potentially contaminated with Salmonella
Worldwide Distribution - US (Nationwide) Internationally to   Canada, Australia, Brazil, Japan, Korea, Mexico, Bahrain, Egypt, Greece  Hungary, Ireland, Israel, Jordan, Kazakhstan, Lithuania, Mauritius  Namibia, Norway,  Pakistan, Poland, Qatar, Romania,  Russian Federation  South Africa, Spain, Turkey, United Arab Emirates, United Kingdom  Algeria, Armenia, Austria, Bahrain, Belarus, Belgium, Botswana  Bulgaria, Cyprus,  Czech Republic, Denmark, Egypt, Finland, France  Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Kenya, Lebanon  Lithuania, Macedonia, Malawi, Malta, Mauritius,  Mozambique, Netherlands  Norway, Oman, Poland, Portugal,  Qatar, Republic of Moldova, Romania  Saudi Arabia, Serbia, Slovakia, Sudan, Sweden,  Switzerland, Tunisia  Turkey, Uganda, Ukraine,  United Kingdom, Yemen, and Zimbabwe
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only  Product Usage:    The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs). The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm.
All Newport Medical HT70 and HT70- Plus Ventilators
Possible contamination of chili seasoning mix with Salmonella.
Life Rising Formulas SHT Chest Relief, 54 Capsules; Manufactured for: Nature's Health (USA) Chicago, IL 60616
Product potentially contaminated with lead.
Worldwide Distribution - US Nationwide in the states of TX, FL, MO, NJ, WI, AL, TX, CA, OK, AZ, NC, GA, ID, WA, NY, NM and the countries of:  Brazil, Canada, China, Taiwan, Canada, and Belgium.
MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201    Product Usage:  The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the surgeon to follow in the excision of the lesion. Product Codes 47020, 475201, 477201,479201, and 470201 do not have the ultrasound enhancement shown in Figure 1. In addition,Product Codes 475201, 477201, 479201, and 470201 may be placed under MRI guidance.  .
It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire.
REYB1777  REZI0726  REZI0988  REZK0741  REZL0066  REAN0884
ALDI stores in Alabama, Kentucky, Michigan, Mississippi, North Carolina, South Carolina, Tennessee and Virginia.
Trail's End   Chicago Cubs Sweet and Savory Collection  Trail's End  Chicago Cubs Chocolate Lover's Collection  Trail's End  Chicago Blackhawks Collection Tin    Snack mixes containing: Chocolate Caramel Corn; Chocolate Pretzels; White Chocolate Pretzels; White Cheddar Popcorn; Butter Toffee Caramel Corn.     Tins contain 3-4, bags of the  snack items listed, each bag ranging in size from 5oz. to 20oz.
Product has the potential to be contaminated with Salmonella
Expiration dates found on individual bags  7/18/2017  7/31/2017  8/1/2017
Product was shipped to the following states: MN, NY, OH, PA & WI.
The firm was notified by a customer that they received product that was mislabeled due to undeclared peanuts.
Destination Renal Guiding Sheath    Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Terumo Product  Code - RSR01    Affected Lot  Numbers    RN19   RN26   RP03
Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R, QTY: (1)
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)
RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)
RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)
RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)
US Distribution was made to medical facilities located in AL, FL, ID, LA, MO, NC, OK, SC, TX, and UT.  There was government distribution and no foreign/military distribution.
Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001.  The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
after the flow zeroing procedure that is conducted automatically 1 hour after start up.  This could result in the potential of a small bias added to the CO2 measurement and affect the alarm notification.
US Distribution.    This product has been sold to both distribution companies with multiple locations and directly to end users/hospitals in US.
According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients.  A small percentage of the catheters in the affected lots may have damage to the ETFE catheter which may allow the catheter to break during withdrawal.
US: AL, AZ, CT, FL, HI, IL IN, IA, KY, LA, ME, MI, MO, NJ,NY, OH, OR, PA, SC, TN, TX, VA, WA, WI.    OUS; GERMANY, GREAT BRITAIN, POLAND, NETHERLANDS
The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The  System includes multiple distal ports located at the catheter tip, which are designed to provide independent infusion and aspiration functions for the active removal of fluid, excised tissue and thrombus from the peripheral treatment site.
Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these units being mislabeled. Some 1.85mm JETSTREAM SC catheters may have been labeled as 2.1mm catheters, and some 2.1mm JETSTREAM XC catheters may have been labeled as 1.85mm catheters.
Worldwide - US Nationwide in the countries of:  Angola, Australia, Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Israel, Italy, Malaysia, Nambia, Netherlands, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Kingdom and Zambia
AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1    Product Usage:  The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV).
Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files.
Distributed to the following states: DE, FL, MD, NC, NJ, NY, PA, TX, VA
Pre-cooked, chilled, Fresh Claw Crabmeat, 1 lb, packaged in plastic container with plastic lid.  King Crab and Seafood De Venezuela, product of Venezuela.
Products may be contaminated with Listeria monocytogenes.
Precooked, chilled, Fresh Jumbo Lump Crabmeat, 1 lb, packaged in plastic container with plastic lid. King Crab and Seafood De Venezuela, product of Venezuela.
Pre-cooked, chilled, Fresh Lump Crabmeat, 1 lb, packaged in plastic container with plastic lid.  King Crab and Seafood De Venezuela, product of Venezuela.
Worldwide Distribution -US ( Nationwide) and Internationally to Canada, Costa Rica,   Norway, Paraguay, Ireland, Panama,  Ecuador, Hong Kong, Malaysia,  Italy, UAE, Guatemala, Iceland, Indonesia, and Saudi Arabia.
Dale Medical Stabilock  Endotracheal Adhesive Base  Product # 273  The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation
ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.
Dale Medical Stabilock  Endotracheal Tube Holder  Product # 270  The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation
H.E. B. brand Pomegranate Infused Cranberries COVERED IN Dark Chocolate, NET WT. 8 OZ. (227g), UPC CODE 041220985883
The product may contain undeclared almonds.
Illinois, Michigan, Ohio, Virginia, and New Jersey
Nabelsi Thyme (also known on invoices as Zatar)  450g retail (24 packages per wholesale case)   4.5kg retail (2 bags per wholesale case)  Cardboard box wholesale case, retail packages flexible plastic
95 cases of 24(450g), 10 cases of 2 bags(4.5kg)
Dressing Rect L, P/N 02428    Product Usage:  These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
They may not have been sealed prior to sterilization.  Products with unsealed pouches will be non-sterile.
Dressing Back, P/N 09810    Product Usage:  These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Dressing Shldr, P/N 04908    Product Usage:  These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Dressing M/U XL, P/N 02344    Product Usage:  These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Dressing Knee/Shldr, P/N 02328    Product Usage:  These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Dressing, Knee L/XL, P/N 04708    Product Usage:  These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Dressing Shldr XL, P/N 04918    Product Usage:  These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
If Hip, Sterile Polar Dressing P/N 10680    Product Usage:  These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Allergy Relief, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072, UPC 3-59726-72025-0; (c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24, UPC 0-75450-12369-2; (d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24, UPC 3-59726-72025-0; (e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24, UPC 8-83967-39839-3.
Subpotent:  This product is being recalled due to low out of specification assay results at the 9 month time point.
Worldwide Distribution -- US: CA, CO, CT, DE, GA, HI, IA, IL, KS, MA, MS, NC, NH, NM, NY, OH, PA, PR, RI, UT, VA, VT, WA, and WV; and, the countries of AE,   BH, CA, CZ, FR, GB, HK, SA, and TR.
Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700  Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707  Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles.  Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle.    Intended for use as a kit in special stain techniques.
Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.
Beyond Beef Feisty Crumble Vegan Gluten-free Non-GMO Weight: 10 lbs. (2) 5 lb. bags UPC: 10852629004412 KEEP FROZEN 111 Main Street El Segundo, CA 90245 866-756-4112 customer@beyondmeat.com www.beyondmeat.com; Beyond Meat Beyond Beef Crumbles Feisty Net WT 11oz (312g) KEEP FROZEN Plant Based Protein Crumbles UPC: 852629004132
4665 cases (3856 retail packages/8366 food service packages)
Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m  NDC 51522-0694-5.
Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
Tropicana 100% JUICE, orange juice From Concentrate with Other Natural Flavors, 24-10 FL OZ (296 mL) BOTTLES, (TOTAL 240 FL OZ (1.8 GAL) 7L), UPC 48500 75823, Tropicana Manufacturing Company, Inc., Bradenton, Florida 34206 USA
One lot of Tropicana orange juice, may have small plastic fragments.
Lot Code # 030617WL, Use by Date: Sept 02 17
Plateletpheresis products, lacking proper quality control testing, were distributed.
Plateletpheresis products, lacking proper quality control procedures, were distributed.
Hand Crafted, LG Paleteria, La Granja, Mango Flavored Ice cream, Wt. 4 oz., in clear flexible plastic wrap.
UPC code 0010439212, Dates of Expiration are 210218 (February 21, 2018) and 280218 (February 28, 2018).
Worldwide Distribution - US  Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy
The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.
Blood and Blood Products for Reprocessing
Blood products, for which the donor gave history which warranted deferral and was not deferred, were distributed.
Blood products, for which unit labeling was incorrect, were distributed.
US: AZ (shipped through Belgium to USA), MN, TN
DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI  NDC 0904-6509-04
Superpotent Drug; out of specification results for assay (manufacturer)
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61
Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC  0904-6501-61
Source Naturals  Dietary Supplement Vitamin D-3;   Bioactive Form for Bone and Immune Health  2000 IU per serving, 500% DV.  Other ingredients: Vegetable Glycerin, Deionized water, citric acid, Natural orange flavor and lemon essential oil.  Use 5 drops once daily in a drink.  Packed in glass bottles in the following sizes:   Unit Size 1 fl. oz. (29.57 mL), UPC 0 21078 02274 9;  2 fl. oz. (59.14 mL) - UPC 0 21078 02275 6  4 fl. oz. (118.28 mL), UPC 0 21078 02276 3 glass bottles:    Codes: 1 ounce glass bottle: SN2274; XUB078;  2 ounce glass bottle: SN2275;  4 ounce glass bottle: SN2276.    Manufactured for:  Source Naturals, Santa Cruz, CA.
Testing of Vitamin D-3 as a result of a consumer complaint found specific lots to have lower concentrations than product specifications of ingredient labeling.
Platelet product, for which pH quality control testing did not meet specifications, was distributed.
American National Red Cross Great Lakes Region
Blood products, for which the donor health history screening  questions were unanswered, were distributed.
Whole Foods Market Cold Pressed Juice, Apple;  16 FL. Oz. (1 pt) 473 mL.  Keep refrigerated - Enjoy within 5 days of opening.  UPC 8 13377 02154 3
Urban Remedy is voluntarily recalling Non-Dairy Spiced Golden Milk that was mislabeled as cold pressed apple juice. The ingredient list does not list tree nuts.