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 1280112820 of 28,964 recalls

Medical DeviceNovember 15, 2019· Arrow International Inc

Recalled Item: Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J Recalled by...

The Issue: Potential leak in the balloon extension line. If a leak was present and went...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 15, 2019· Arrow International Inc

Recalled Item: Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130 Recalled by...

The Issue: Potential leak in the balloon extension line. If a leak was present and went...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 14, 2019· Cardinal Health Inc.

Recalled Item: Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent...

The Issue: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 14, 2019· Cardinal Health Inc.

Recalled Item: S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent...

The Issue: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 14, 2019· Cardinal Health Inc.

Recalled Item: Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T....

The Issue: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 13, 2019· Linet Spol. S.r.o.

Recalled Item: Eleganza 5 (AC powered adjustable bed) Recalled by Linet Spol. S.r.o. Due to...

The Issue: A component used within the side rail mechanism may malfunction, resulting...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 13, 2019· GETINGE US SALES LLC

Recalled Item: Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion...

The Issue: Sterile barrier system may be compromised

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 12, 2019· Aesculap Implant Systems LLC

Recalled Item: ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with...

The Issue: Nonfunctional key due to the potential for damage to the key pins cause by...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 11, 2019· Nextremity Solutions

Recalled Item: Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST Recalled by...

The Issue: Components 2mm shorter than indicated on the package label

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 11, 2019· Nextremity Solutions

Recalled Item: Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST Recalled by...

The Issue: Components 2mm shorter than indicated on the package label

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 11, 2019· Nextremity Solutions

Recalled Item: Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST Recalled by...

The Issue: Components 2mm shorter than indicated on the package label

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 11, 2019· Abbott Medical

Recalled Item: CLASSIC Radiofrequency Cannula - Curved Recalled by Abbott Medical Due to A...

The Issue: A manufacturing error caused a single lot of 10mm active tip length Cannulas...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 11, 2019· Smith & Nephew, Inc.

Recalled Item: smith&nephew PROFIX Mallet Recalled by Smith & Nephew, Inc. Due to There is...

The Issue: There is a a potential failure mode associated with the use of the mallet,...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 8, 2019· Boston Scientific Corporation

Recalled Item: AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H...

The Issue: Missing Directions for Use (DFU) - Consoles shipped to customers without the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 7, 2019· Beckman Coulter Inc.

Recalled Item: iChem VELOCITY Urine Chemistry Analyzer Recalled by Beckman Coulter Inc. Due...

The Issue: Beckman Coulter has become aware of an issue affecting Specific Gravity...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 7, 2019· Ethicon Endo-Surgery Inc

Recalled Item: Ligamax 5 mm Endoscopic Multiple Clip Applier Recalled by Ethicon...

The Issue: A potential exists that certain LIGAMAX devices within the impacted lots may...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 7, 2019· Neuronetrix Solutions, LLC dba Cognision

Recalled Item: Cognision Recalled by Neuronetrix Solutions, LLC dba Cognision Due to...

The Issue: Product has the potential to be contaminated with Burkholderia cepacia (B....

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 7, 2019· Abbott Gmbh & Co. KG

Recalled Item: ARCHITECT HAVAB-G Calibrator Recalled by Abbott Gmbh & Co. KG Due to Abbott...

The Issue: Abbott has identified that Calibrator lot 08219BE00 is potentially impacted...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 6, 2019· Qualigen Inc

Recalled Item: The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative...

The Issue: The chemiluminescent immunoassay has been noted to have higher than expected...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 6, 2019· Allergan PLC

Recalled Item: Natrelle Silicone Filled Breast Implants for the following Styles and...

The Issue: The firm has became aware that 2D barcodes on breast implants and sizers may...

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

Class III — Low RiskOngoing