Product Recalls in Colorado

Product recalls affecting Colorado — including food, drugs, consumer products, medical devices, and vehicles distributed to Colorado. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,425 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
2,425 in last 12 months

Showing 4258142600 of 51,434 recalls

Medical DeviceSeptember 30, 2014· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Siemens Dimension HB1C Flex reagent cartridge Recalled by Siemens Healthcare...

The Issue: Certain lots of the reagent cartridges show confirmed positive bias...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
DrugSeptember 30, 2014· Gilead Sciences, Inc.

Recalled Item: Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)...

The Issue: Presence of Foreign Substance: Truvada was found to contain small red...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
FoodSeptember 30, 2014· Ikea North America Srvcs Inc

Recalled Item: Elk shaped pasta Ekologiska PASTA-ALGAR FULLKORN Pasta elks wholemeal...

The Issue: Pasta-Algar and Pasta-Algar Fullkorn are recalled due to undeclared soy.

Recommended Action: Do not consume. Return to store for a refund or discard.

Class II — Potential Health HazardOngoing
Refund
FoodSeptember 30, 2014· Ikea North America Srvcs Inc

Recalled Item: Elk shaped pasta Ekologiska PASTA-ALGAR Pasta elks Recalled by Ikea North...

The Issue: Pasta-Algar and Pasta-Algar Fullkorn are recalled due to undeclared soy.

Recommended Action: Do not consume. Return to store for a refund or discard.

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 29, 2014· Baxter Healthcare Corp.

Recalled Item: DOPamine Hydrochloride and 5% Dextrose INJ Recalled by Baxter Healthcare...

The Issue: Lack of Assurance of Sterility: A small cut in the solution bag may have...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
Medical DeviceSeptember 29, 2014· Coloplast Manufacturing US, LLC

Recalled Item: Coloplast Conveen Urine Collection Leg Bag Recalled by Coloplast...

The Issue: Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 29, 2014· Merge Healthcare, Inc.

Recalled Item: Merge Healthcare Recalled by Merge Healthcare, Inc. Due to It has been...

The Issue: It has been reported that during use, the SpO2 value displayed on the Hemo...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 29, 2014· Smiths Medical ASD, Inc.

Recalled Item: CADD-Solis Medication Safety Software Recalled by Smiths Medical ASD, Inc....

The Issue: Smiths Medical has identified an issue with a single batch (Lot Number...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 29, 2014· Integra LifeSciences Corp.

Recalled Item: Integra Selector Kit Sterile single use device A bi-lumen Recalled by...

The Issue: Some specific lots of Selector Tubing may potentially leak irrigation fluid...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 29, 2014· Ortho-Clinical Diagnostics

Recalled Item: VITROS Software Version 3.1 utilized on the following systems: 1) Recalled...

The Issue: Calibration may not occur when using calibrator barcode labels supplied with...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
DrugSeptember 26, 2014· Actavis Laboratories, FL, Inc.

Recalled Item: Diclofenac Sodium and Misoprostol Delayed-Release Tablets Recalled by...

The Issue: Failed Tablet/Capsule Specifications: Presence of split or broken tablets.

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 26, 2014· Forest Pharmaceuticals Inc

Recalled Item: Bystolic (nebivolol) tablets Recalled by Forest Pharmaceuticals Inc Due to...

The Issue: Failed Dissolution Specification; at the 6-month stability time point

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 26, 2014· Sun Pharma Global Inc.

Recalled Item: Venlafaxine Hydrochloride Extended-Release Tablets Recalled by Sun Pharma...

The Issue: Failed Dissolution Specifications; 12 month stability time point

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
Medical DeviceSeptember 26, 2014· Teleflex Medical

Recalled Item: Pilling Knife Handles: a) b) c) Recalled by Teleflex Medical Due to The...

The Issue: The knife handles slot depth is out of specification, so blades may not fit...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2014· Amerx Health Care Corp.

Recalled Item: Amerigel Post-op Surgical Kits Wound management Recalled by Amerx Health...

The Issue: Formulation deviation

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2014· Biomet, Inc.

Recalled Item: Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments...

The Issue: An investigation identified that high level friction may exist between the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2014· Merit Medical Systems, Inc.

Recalled Item: Merit Maestro Microcatheter Recalled by Merit Medical Systems, Inc. Due to...

The Issue: These microcatheters were packaged with a 2.8 F distal tip, rather than the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2014· Amerx Health Care Corp.

Recalled Item: Amerigel Saturated Gauze Dressing Wound management Recalled by Amerx Health...

The Issue: Formulation deviation

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2014· Cook Medical Incorporated

Recalled Item: Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set...

The Issue: MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2014· Amerx Health Care Corp.

Recalled Item: Amerigel Hydrogel Wound Dressing Wound management Recalled by Amerx Health...

The Issue: Formulation deviation

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing