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. 2,509 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
2,509 in last 12 months

Showing 2584125860 of 28,964 recalls

Medical DeviceOctober 3, 2013· Synthes USA HQ, Inc.

Recalled Item: Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual Recalled...

The Issue: Complaints were received for intraoperative reamer head breakages which can...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 3, 2013· Synthes USA HQ, Inc.

Recalled Item: Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to...

The Issue: During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 3, 2013· Advanced Sterilization Products

Recalled Item: STERITITE Containers: STERITITE Container Kit Recalled by Advanced...

The Issue: Advanced Sterilization Products (ASP) is recalling the SteriTite containers...

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

Class III — Low RiskOngoing
Medical DeviceOctober 3, 2013· Synthes USA HQ, Inc.

Recalled Item: Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes...

The Issue: A potential exists for non conforming Synthes Titanium Trochanteric Fixation...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 2, 2013· Intuitive Surgical, Inc.

Recalled Item: Single Site Curved Needed Driver Intuitive Surgical Recalled by Intuitive...

The Issue: A limited number of FDA-cleared instruments for da Vinci Single Site use,...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 2, 2013· Nipro Diagnostics, Inc.

Recalled Item: MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for...

The Issue: Manufactured with an incorrect factory set unit of measure.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 2, 2013· Nipro Diagnostics, Inc.

Recalled Item: MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for...

The Issue: Manufactured with an incorrect factory set unit of measure.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 2, 2013· Beckman Coulter Inc.

Recalled Item: Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System...

The Issue: Beckman Coulter is initiating a recall for the Access Immunoassay Systems...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 2, 2013· Intuitive Surgical, Inc.

Recalled Item: Single Site Bipolar Maryland Forceps Intuitive Surgical Recalled by...

The Issue: A limited number of FDA-cleared instruments for da Vinci Single Site use,...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 2, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Recalled by Stryker Instruments Div. of Stryker Corporation Due to It was...

The Issue: It was discovered that the silicone potting failed to properly cure after...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2013· GE Healthcare, LLC

Recalled Item: GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System Recalled...

The Issue: Oxygen and air wall inlet fittings on the back panel of the resuscitation...

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

Class I — Serious Health HazardOngoing
Medical DeviceOctober 1, 2013· GE Healthcare, LLC

Recalled Item: GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Recalled by...

The Issue: Oxygen and air wall inlet fittings on the back panel of the resuscitation...

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

Class I — Serious Health HazardOngoing
Medical DeviceOctober 1, 2013· GE Healthcare, LLC

Recalled Item: GE Healthcare - Giraffe Warmer Recalled by GE Healthcare, LLC Due to Oxygen...

The Issue: Oxygen and air wall inlet fittings on the back panel of the resuscitation...

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

Class I — Serious Health HazardOngoing
Medical DeviceOctober 1, 2013· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker...

The Issue: Stryker received a report from the field indicating that a 5.5 mm Cancellous...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2013· Toshiba American Medical Systems Inc

Recalled Item: TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System Recalled by...

The Issue: Toshiba intitiated this recall because their investigation revealed that due...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2013· Helix Medical LLC

Recalled Item: Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3...

The Issue: InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable...

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

Class III — Low RiskOngoing
Medical DeviceSeptember 30, 2013· Draeger Medical, Inc.

Recalled Item: Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended Recalled by...

The Issue: Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 30, 2013· Ethicon Endo-Surgery Inc

Recalled Item: Adjustable Gastric Band Recalled by Ethicon Endo-Surgery Inc Due to During...

The Issue: During aging studies, the firm determined that the gastric belts were unable...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 30, 2013· Medtronic Neuromodulation

Recalled Item: Medtronic RestoreUltra Recalled by Medtronic Neuromodulation Due to...

The Issue: Medtronic notified customers regarding Loss of Stimulation of specific...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 30, 2013· Synthes USA HQ, Inc.

Recalled Item: Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Recalled by...

The Issue: A potential non conformance was identified with the Zero-P VA plate where...

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

Class II — Potential Health HazardOngoing