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. 2,538 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
2,538 in last 12 months

Showing 2208122100 of 28,964 recalls

Medical DeviceSeptember 6, 2015· Philips Healthcare

Recalled Item: Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System...

The Issue: Software Defects resulting in: (1) sagittal result shortened for axial...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 6, 2015· Philips Healthcare

Recalled Item: Philips Healthcare Ingenuity Core Computed Tomography X-Ray System Recalled...

The Issue: Software Defects resulting in: (1) sagittal result shortened for axial...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 6, 2015· Philips Healthcare

Recalled Item: Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System Recalled...

The Issue: Software Defects resulting in: (1) sagittal result shortened for axial...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 6, 2015· Philips Healthcare

Recalled Item: Philips Healthcare Ingenuity CT Computed Tomography X-Ray System Recalled by...

The Issue: Software Defects resulting in: (1) sagittal result shortened for axial...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2015· Synthes (USA) Products LLC

Recalled Item: 5.0mm Unit Rod 270mm Recalled by Synthes (USA) Products LLC Due to This...

The Issue: This product was produced using a finishing process not identified as part...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2015· Dako North America Inc.

Recalled Item: EnVision FLEX/HRP visualization reagent found in the following kits:...

The Issue: There is a defect in one lot of a buffer, non-specific background staining...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 3, 2015· Leica Microsystems, Inc.

Recalled Item: Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10)....

The Issue: These Lot numbers are not stable up to the expiry date on the product labeling.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 3, 2015· Synthes (USA) Products LLC

Recalled Item: Inserter for Titanium Elastic Nails (TEN) Recalled by Synthes (USA) Products...

The Issue: potential for mechanical failures such as breakage.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 3, 2015· Roche Diagnostics Operations, Inc.

Recalled Item: Cobas b 123 POC system The cobas b 123 POC Recalled by Roche Diagnostics...

The Issue: under specific settings, an issue may occur during simultaneous Sensor...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 3, 2015· Steris Corporation

Recalled Item: AMSCO 400 and AMSCO C Small Steam Sterilizers Recalled by Steris Corporation...

The Issue: In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the...

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

Class III — Low RiskOngoing
Medical DeviceSeptember 3, 2015· Bausch & Lomb Inc Irb

Recalled Item: BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A) Recalled by Bausch & Lomb...

The Issue: The firm determined that 25 lots had been manufactured with a minor surface...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 3, 2015· Zimmer Gmbh

Recalled Item: Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer...

The Issue: In about 5% of tested samples, the outer tray was found to be compromised....

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 1, 2015· Medtronic Inc. Cardiac Rhythm Disease Management

Recalled Item: Medtronic CryoConsole Recalled by Medtronic Inc. Cardiac Rhythm Disease...

The Issue: An issue with a USB memory component contained within a subset of...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2015· ConforMIS, Inc.

Recalled Item: ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2 Recalled by...

The Issue: May contain small amounts of ethylene glycol residue

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2015· ConforMIS, Inc.

Recalled Item: ConForMIS iDuo Knee Bicompartmental Knee Replacement System Recalled by...

The Issue: May contain small amounts of ethylene glycol residue

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2015· ConforMIS, Inc.

Recalled Item: ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2 Recalled by...

The Issue: May contain small amounts of ethylene glycol residue

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2015· ConforMIS, Inc.

Recalled Item: ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2 Recalled by...

The Issue: May contain small amounts of ethylene glycol residue

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2015· Elekta, Inc.

Recalled Item: XiO Radiation Treatment Planning System. Used to create treatment plans...

The Issue: Incorrect Treatment Delivery Using Third Party Fixed Wedges.

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2015· Fujifilm Medical Systems U.S.A., Inc.

Recalled Item: Fujifilm Medical Systems Duodenoscope Recalled by Fujifilm Medical Systems...

The Issue: A precautionary measure because the Duodenoscopes have been redesigned to...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2015· ConforMIS, Inc.

Recalled Item: ConFormis iDUO G2 Recalled by ConforMIS, Inc. Due to May contain small...

The Issue: May contain small amounts of ethylene glycol residue

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

Class II — Potential Health HazardOngoing