Worldwide Distribution - US Distribution to the states of :  KS, MS, WI, NJ, KS, IN, LA, FL and WA., and to the countries of : Canada, Australia, Singapore, Netherlands, UK, Austria, Germany, Switzerland and Czech Republic.
NDI P7 Position Sensor, Stereotaxic Instrument
Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on  Sesamoid and Sesamoid Plasty CAS workstations due to a series  of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage.
Macaroni & Cheese microwaveable cups sold under the following brands:    1.  Big Win Original Macaroni & Cheese Dinner, UPC 11822-58403.    2.  Cheese Club express mac Macaroni  Cheese Dinner, UPC 41498-17167,    3.  Great Value Macaroni & Cheese Dinner, UPC  78742-08249.
Products containing cheddar cheese seasoning which may be contaminated with Salmonella.
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.
Indications for use are not cleared or approved for market in the U.S.
Apheresis Red Blood Cells, Leukocytes Reduced
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood and Blood Products for Reprocessing
Blood product, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.
Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India, NDC 62756-551-18.
Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
Sample probes associated with:  cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer   cobas c 501/502  cobas c 701/702  cobas 8000 ISE    Product Usage:  The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyzer Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit. The cobas c 311 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and lead to a disturbance of the sample liquid level detection (LLD). When disturbance of the sample liquid level detection (LLD) occurs, the affected  sample probe may dip into the sample material deeper than intended. This may lead to carryover and medical risk cannot be excluded.
During an internal investigation the firm discovered that an ingredient used in various spices may contain Salmonella.
US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.
Mentor Smooth Round SPECTRUM Post-  Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v)  240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412  USA   NDC: 0024-5862-01
Labeling: Incorrect or Missing Package Insert
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product was distributed to wholesalers for retail sale:  AL, CO, GA, KS, MO, MS, NY, OK, LA, PA, TX, WI. There was no foreign/government/military distribution.
Reser's Fine Foods, American Classics Macaroni Salad, Net Wt 1 lb. (454 g) UPC 7117.19007, packaged in 16 oz plastic tubs, 12 per case. Reser's Fine Foods, Inc. Beaverton, OR 97006.
Product contains undeclared milk and soy.
Distributed in MA and the following countries: Denmark, Germany, Japan, and The Netherlands.
on the case and has a poly liner.    This product was to be reprocessed and there are no UPC codes.    Grades PBO A, PBO X, PBO XL, PBO L, and MN PBO A.
Frozen Pollock fillet block is recalled because one customer has found metal fragments in fillet block.
on the case and has a poly liner.    This product was to be reprocessed and there are no UPC codes.    Grades Mince A and MN Mince A
Frozen Pollock mince block is recalled because one customer has found metal fragments in fillet block.
Kloosterboer warehouse lot codes: D-033982 and D-033983.
Blood product, prepared without the appropriate amount of additive, was distributed.
Blood product, which did not meet the acceptable product specifications, was distributed.
Great Value Bread and Butter Chips 24 Fl Oz.   Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716  UPC 078742145990
Glass fragments were found in Great Value Bread and Butter Chips.
Internationally to the country of : India
PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN  38116
This lot of left plates were laser etched and packaged as right plates.
Worldwide distributed - US Nationwide in AZ, CA, CO, CT, FL, GA, IA, IL, IN, MA, MN, MO, NC, NJ, NV, NY, OH, PA, TN, TX, WA, and WI, and internationally in Canada, Netherlands, and South Korea.
1773 devices (US =1570; International = 203)
Microfil Composite Instruments were distributed with a sterile symbol on their packaging label inserts, indicating that the products are sold as sterile devices. These products are not sterile and they are intended to be sterile prior to each use.
Worldwide Distribution - Nationwide Distribution and to the countries of: Turkey, Great Britain, Belgium, Kuwait, Poland, Italy, India, China, Costa Rica,  Australia, Malaysia, Jordan and  Egypt.
Mederi Stretta Catheter and Accessory Kit, Sterile   For Use with the MEDERI MDRF1 GENERATOR ONLY.  Used in the treatment of gastroesophageal reflux disease (GERD).    REF 175-5580
Product sterility compromised due to breach in sterile barrier package
Worldwide Distributed - US Nationwide in the states of: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN, KS,KY,LA,MA,MD, ME, MI, MN, MO, MS, MT, NC,ND,NE, N H, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and countries of: AUSTRALI A,BAHAMAS,BRAZIL,CANADA, COLOMBIA, COSTA RICA, DENMARK, ENGLAND, GREECE, GUAM, ISRAEL, LITHUANIA, MALAYSIA, NETHERLANDS, NEW ZEALAND, PANAMA, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, and SWEDEN
CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit.    Product Usage:  The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).
The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber.
Nationwide  Foreign:  Australia  Bangladesh  Chile  Colombia  France  Germany  Hong Kong  India  Ireland  Japan  Latvia  Mexico  Spain  Switzerland  Thailand  Uruguay
Potential Patient Demographic Error with Blank Patient ID Field
Fresh Mozzarella;  No brand name. Shipped in 30 lb. plastic bucket
Belfiore Cheese was notified by their direct account that cheese received had noticeable metal fragments in the product.
AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico  Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay  and (Japan - DOD)
Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Some eyelets broke from SwiveLock Anchor on insertion.
Unique Device Identifier: 00888867160231  Batch Number: 10070003 - Expiration Date 9/30/2021
Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Unique Device Identifier: 00888867026865  Batch Number: 10072425 - Expiration Date 10/31/2018  Batch Number: 10073992 - Expiration Date 10/31/2018  Batch Number: 10077133 - Expiration Date 10/31/2018  Batch Number: 10078077 - Expiration Date 11/30/2018  Batch Number: 10078340 - Expiration Date 11/30/2018  Batch Number: 10075792 - Expiration Date 10/31/2018
Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Unique Device Identifier: 00888867026803  Batch Number: 10078258  Expiration Date 12/01/2021
Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Unique Device Identifier: 00888867027329  Batch Number: 10072597 - Expiration Date 10/31/2018  Batch Number: 10074288 - Expiration Date 10/31/2018  Batch Number: 10076753 - Expiration Date 10/31/2018  Batch Number: 10076852 - Expiration Date 10/31/2018  Batch Number: 10081420 - Expiration Date 11/30/2018  Batch Number: 10075965 - Expiration Date 10/31/2018  Batch Number: 10077252 - Expiration Date 10/31/2018  Batch Number: 10084027 - Expiration Date 12/31/2017
Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Unique Device Identifier: 00888867026766  Batch Number: 1078259  Expiration Date 11/30/2018
Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Unique Device Identifier: 00888867026926  Batch Number: 10072597 - Expiration Date 10/31/2021
Stryker Instruments Div. of Stryker Corporation
US (nationwide) Distribution to the states of :  CA, CT, GA, IL, IN, MA, MD, NC, OH, PA, TN, and TX.
Stryker PROFESS Registration Kit.  The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a PROFESS Patient Tracker, and a PROFESS Adaptor Cable.
Product shipped proximate to or past the expiration date listed on the product label.
Lot #202085  Stryker Product Number: 6001-420-000
Stryker Medical Division of Stryker Corporation
USA (nationwide) Distribution and Internationally to Colombia.
The product is sold only in 7-11 stores in Colorado.
7-ELEVEN CAESAR SIDE SALAD 3 oz. packaged in clear plastic container
Undeclared milk, eggs, wheat and fish (anchovies).
US and worldwide:     Austria  Belgium  Croatia  Czech Republic  Denmark  Finland  France  Germany  Great Britain  Iceland  Ireland  Israel  Italy  Latvia  Lebanon  Lithuania  Netherlands  Norway  Portugal  Spain  Sweden  Switzerland  Tunisia  Turkey  Russian Fed  Guadeloupe  Sri Lanka  Australia  China  Hong Kong  Indonesia  Malaysia  Singapore  South Korea  Taiwan  Thailand  Japan  Chile  Colombia  Costa Rica  Ecuador
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
The Bakery Peanut Butter Chocolate Chunk Cookies, Net Wt. 14 oz. (396g), packaged in a clear plastic clam shell, UPC 0 78742 06652 3, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716
The Bakery Peanut Butter Chocolate Chunk Cookies may contain undeclared milk.
US Distribution to the state of : OK  and to the countries of : Italy, Germany, France , Belgium, Spain and Japan.
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle.
Distribution in the United States and Canada
The electrical controller, combined with motor, causes feedback, damaging a component on the control board, starting a fire.
s/n or lot number - Job Number lots 671494 - 672668
Nationwide, Canada, and Japan. No govt/VA/military consignees.
Stromaderm Age-Defying Serum, 1 fluid ounce jar, item number: 400600.  Packaged in Glass jar with glass dropper in a unit carton.  Sold as individual units, Distributed by: Jusuru International, Inc., Anaheim, CA
Maple Mountain Group is recalling Stromaderm Age-Defying Serum because the product may contain microorganisms that may present a potential health hazard.  Lot # 3925 - Pseudomonas aeruginosa and Candida boidinii were found.  Lot #3785-  Lactobacillus rhamnosus, Bacillus ginsengihumi, and  Staphylococcus saprophyticus were found
Lot 3925 Expiration Date: 10/2018  Lot 3785 Expiration Date: 5/2018
AL, AR, AZ, CA, CO, FL, GA, IL, LA, MA, MO, MS, NC, NJ, NY, OH,OK, PA, SC, TX and VA
Vertical Pharmaceuticals OB Complete with DHA Prenatal Multivitamin, 60 softgels Rx Only, Manufactured for: Vertical Pharmaceuticals, LLC Sayreville, NJ 08872 UPC 368025049603
Lot number 21511158 with expiry date 10/20/2017
IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only,  Manufactured by:  Akorn, Inc., NDC 17478-701-02
Product is being recalled due to low pH value.
Nationwide  throughout the US and Puerto Rico
12 count Lays Kettle Cooked Multipack Sack 10.2 oz packaged in flexible plastic
guaranteed fresh date of JUL 4 or prior; UPC 62930
20 count Frito-Lay Bold Mix Sack 18.4 oz. packaged in flexible plastic
guaranteed fresh date of JUL 4 or prior; UPC 64666
32 count Miss Vickies Multipack Box 44 oz. packaged in flexible plastic
guaranteed fresh date of JUL 4 or prior; UPC 22050
30 count Miss Vickies Multipack Tray 41.25 oz. packaged in flexible plastic
guaranteed fresh date of JUL 4 or prior; UPC 5003
30 count Lays Kettle Cooked Multipack Tray 41.25 oz. packaged in flexible plastic
guaranteed fresh date of JUL 4 or prior; UPC 23935
Soylent 1.8 Powder , 7 x 15oz pouches, SKU: 1WK-V108
Rosa Foods is recalling Soylent Bar because it may contain undeclared milk (whey).
Lot #: G7076PA, Expiration / Best Buy date: 02/2018.
Regenerex Patella  RGX 3 PEG SER A PATELLA 28MM  RGX 3 PEG SER A PATELLA 31MM  RGX 3 PEG SER A PATELLA 34MM  RGX 3 PEG SER A PATELLA 37MM    Product Usage:  The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Organic Cocoa-Dusted Chocolate Ginger was recalled due to undeclared hazelnuts.
Lot number on 5lb. bag: 17086.  Product was offered to consumers through a self-serve bulk bin at retail store without any lot coding available.
Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel
Microbial Contamination of Non-Sterile Products
No US distribution.  JAPAN  NETHERLANDS  SINGAPORE  SWITZERLAND
mislabeled as 8mm tube but it is  actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual  8mm subcomponent part.
Part Number: 900738  Lot Number (LN): 889990
Cobalt HV Bone Cement  Cobalt MV Bone Cement  Cobalt HV Bone Cement With Gentamicin
Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.
Model numbers:  402282 and 402282J - Cobalt HV Bone Cement  402438 - Cobalt MV Bone Cement  402283J - Cobalt HV Bone Cement With Gentamicin    402438  Lot: 507830    402282J  Lot: 668140    402282  Lot: 508220    402283J  Lot: 189780
Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).
Linear Broach Handle. Greatbatch Medical has received reports that that the product is breaking at the welds and that the locating pin at the distal end of the instrument is breaking off during use.
The Organic Basil Pesto with Watercress is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Shrimp Burgers are recalled because the Ingredients statement declared butter, shrimp, cod, and/or Pollock but the Contains statement declared only fish & shellfish.
Lot # 5302A. Best By: January 18, 2017.  Lot # 6174A. Best By: June 21, 2017.  Lot # 6259A. Best By: September 23, 2017.
Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY  10977.
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Red Blood Cells, Leukocytes Reduced, Irradiated
Blood products, in which donor suitability was not adequately determined, were distributed.
Red blood cell, for which antigen testing was documented incorrectly, was distributed.