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. 2,652 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
2,652 in last 12 months

Showing 1214112160 of 28,964 recalls

Medical DeviceApril 2, 2020· Abbott Laboratories

Recalled Item: Accelerator APS Aliquoter Module Recalled by Abbott Laboratories Due to In...

The Issue: In the case of an AQM clot detection error a portion of the distilled water...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· GE Healthcare, LLC

Recalled Item: Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001...

The Issue: During Giraffe Shuttle charging, the batteries emit low concentrations of...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 1, 2020· Aesculap Implant Systems LLC

Recalled Item: PRESTIGE RETRACTION GRASPER Recalled by Aesculap Implant Systems LLC Due to...

The Issue: Endoscopic graspers may become separated at the weld from handle to the...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 1, 2020· Aesculap Implant Systems LLC

Recalled Item: PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION Recalled by Aesculap Implant...

The Issue: Endoscopic graspers may become separated at the weld from handle to the...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 1, 2020· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products CKMB Slides Recalled by Ortho-Clinical Diagnostics...

The Issue: The Spanish and Swedish language versions of the IFU state that the assay...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 1, 2020· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products CKMB Slides Recalled by Ortho-Clinical Diagnostics...

The Issue: The Spanish and Swedish language versions of the IFU state that the assay...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 31, 2020· Spectranetics Corporation

Recalled Item: Bridge Occlusion Balloon Recalled by Spectranetics Corporation Due to There...

The Issue: There is a potential for thrombus formation on balloons prepped and staged...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 31, 2020· Becton, Dickinson and Company, BD Biosciences

Recalled Item: Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US) Recalled by...

The Issue: False positive reaction on the reagent.

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 30, 2020· Beckman Coulter Inc.

Recalled Item: iChem¿VELOCITY Urine Chemistry System- Recalled by Beckman Coulter Inc. Due...

The Issue: A defect in the SATA power adapter cable within the instruments computer has...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 30, 2020· Beckman Coulter Inc.

Recalled Item: iQ200 Series Urine Microscopy Analyzer- All part numbers Recalled by Beckman...

The Issue: A defect in the SATA power adapter cable within the instrument s computer...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 30, 2020· Boston Scientific Corporation

Recalled Item: MoXy Laser Fiber Recalled by Boston Scientific Corporation Due to To...

The Issue: To reinforce existing instructions within the Directions for Use (DFU) and...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 30, 2020· Elekta Inc

Recalled Item: Leksell Vantage Stereotactic System. Instrument Carrier Recalled by Elekta...

The Issue: A faulty locking piece of the Instrument Carrier that does not fulfil the...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Shanghai United Imaging Healthcare Co., Ltd.

Recalled Item: Positron Emission Tomography and Computed Tomography System Recalled by...

The Issue: In affected software version, of Positron emission tomography and computed...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Medtronic Sofamor Danek USA Inc

Recalled Item: VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628...

The Issue: Nonconforming product; length of the product measured shorter than the...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Gentell, Inc

Recalled Item: Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing...

The Issue: During an FDA audit, it was discovered that the product was not properly...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Gentell, Inc

Recalled Item: Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing...

The Issue: During an FDA audit, it was discovered that the product was not properly...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Gentell, Inc

Recalled Item: Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing...

The Issue: During an FDA audit, it was discovered that the product was not properly...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Gentell, Inc

Recalled Item: Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing...

The Issue: During an FDA audit, it was discovered that the product was not properly...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 25, 2020· Abbott Vascular

Recalled Item: Xience Sierra TM Everolimus Eluting Coronary Stent System Recalled by Abbott...

The Issue: Incorrect expiration date

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 23, 2020· INARI MEDICAL

Recalled Item: Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/...

The Issue: The hemostasis valve of aspiration guide catheter devices may fail to seal...

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

Class II — Potential Health HazardOngoing