Medical DeviceNov 7, 2018
CMP Industries IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) recall — FDA Z-0292-2019
Foreign material in product
Class IIFDA: TerminatedCMP Industries, LLC
November 2018 recalls — page 13
These records include useful source details for the selected month.
Medical DeviceNov 7, 2018
Beckman Coulter Software Package, Sorting-Drive 4.2 User Kit, Part No recall — FDA Z-0354-2019
Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the Sorting-Drive Client that is used for manual printing of barcodes. When printing…
Class IIIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceNov 7, 2018
Cook Medical Zilver 635 Biliary Stent 14mm x 60mm recall — FDA Z-0330-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Cook Medical Zilver 635 Biliary Stent 14mm x 80mm recall — FDA Z-0352-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Cook Medical Zilver 635 Biliary Stent 12mm x 60mm recall — FDA Z-0339-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Zimmer Biomet EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone recall — FDA Z-0286-2019
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Class IFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 7, 2018
Philips Medical Systems (Cleveland) Ingenuity Core (Model No. 728321), Software version recall — FDA Z-0309-2019
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceNov 7, 2018
Cook Medical Zilver 635 Biliary Stent 5mm x 30mm recall — FDA Z-0347-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Becton Dickinson & Co BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364 recall — FDA Z-0312-2019
A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true…
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceNov 7, 2018
Cook Medical Zilver 518 Biliary Stent 5mm x 30mm recall — FDA Z-0320-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Stryker GmbH Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040 recall — FDA Z-0291-2019
The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a…
Class IIFDA: TerminatedStryker GmbH
Medical DeviceNov 7, 2018
Becton Dickinson & Co BD Max Instrument, Catalog Number 441916 441927 recall — FDA Z-0313-2019
A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true…
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceNov 7, 2018
Cook Medical Zilver 635 Biliary Stent 14mm x 30mm recall — FDA Z-0341-2019
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Class IIFDA: TerminatedCook Medical Inc.
Medical DeviceNov 7, 2018
Philips Medical Systems (Cleveland) IQon Spectral CT (Model No. 728332), Software Version recall — FDA Z-0306-2019
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
FoodNov 7, 2018
Caito Foods LLC MUSHROOM PRTBELA SOUTHWEST STUFFED recall — FDA F-0360-2019
Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.
Class IIFDA: TerminatedCaito Foods LLC.
FoodNov 7, 2018
Vosges Haut-Chocolat Caramels et Chocolats recall — FDA F-0353-2019
Multi-pack product does not declare wheat on outer packaging, wheat is declared on inner packaged products.
Class IIFDA: TerminatedVosges Haut-Chocolat
FoodNov 7, 2018
Buddy's Kitchen Beef Barbacoa on Telera, Item 70663 recall — FDA F-0334-2019
Buddy's Kitchen is recalling several products in response to the McCain Foods recall due to potential Listeria or Salmonella contamination.
Class IIFDA: TerminatedBuddy's Kitchen Inc.
FoodNov 7, 2018
CFS West Holdings Houlihan's Creamy Garlic Ranch Dressing potentially labeled as recall — FDA F-0342-2019
A complaint received from a customer that a case of Creamy Ranch with Garlic was mislabeled as Horseradish Sauce. The ranch dressing contains the major food allergen of milk which is not…
Class IFDA: TerminatedCFS West Holdings Inc.
FoodNov 7, 2018
AJINOMOTO WINDSOR Posada Hatch Green Chile & Cheese Burrito, 72/4.5 oz burritos recall — FDA F-0344-2019
Firm was notified by a supplier of a voluntary recall of diced green peppers due to the potential contamination of Salmonella and/or Listeria.
Class IIFDA: TerminatedAJINOMOTO WINDSOR Inc.
FoodNov 7, 2018
APOLLO FOOD INTERNATIONAL Mini Roll, The product comes in a 2.469 ounce pink plastic recall — FDA F-0350-2019
Product contains undeclared eggs.
Class IFDA: TerminatedAPOLLO FOOD INTERNATIONAL Inc.
FoodNov 7, 2018
GOURMET SPECIALTIES Fresh Herb Basil 62/4oz., LB 2489, 135/5Bulk, 24/8oz., 12/10 recall — FDA F-0076-2019
Potential Cyclospora cayetanensis contamination.
Class IIFDA: TerminatedGOURMET SPECIALTIES Inc.
FoodNov 7, 2018
Caito Foods LLC SOUTHWEST CRIMINI STUFFED MUSHROOM recall — FDA F-0354-2019
Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.
Class IIFDA: TerminatedCaito Foods LLC.
FoodNov 7, 2018
D & D Foods Hy-Vee Spinach, Tomato, Mozzarella Twice Baked Potatoes, Net recall — FDA F-0347-2019
The firm received a recall notice for fire roasted tomatoes and mushrooms because they may potentially be contaminated with Listeria monocytogenes and Salmonella. The firm further…
Class IIFDA: TerminatedD & D Foods, Inc.
FoodNov 7, 2018
Buddy's Kitchen Beef Barbacoa on Panini Focaccia, Item 70659 recall — FDA F-0333-2019
Buddy's Kitchen is recalling several products in response to the McCain Foods recall due to potential Listeria or Salmonella contamination.
Class IIFDA: TerminatedBuddy's Kitchen Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.