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. 1,124 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
1,124 in last 12 months

Showing 12841–12860 of 28,964 recalls

Medical DeviceNovember 4, 2019· Immuno-Mycologics, Inc

Recalled Item: Histoplasma Immunodiffusion (ID) Antigen Recalled by Immuno-Mycologics, Inc...

The Issue: False positive results due to potential contamination of reagent.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2019· Villa Sistemi Medicali S.P.A.

Recalled Item: Apollo Recalled by Villa Sistemi Medicali S.P.A. Due to An amendment to the...

The Issue: An amendment to the IFU and Service Manual is being issued to prescribe the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2019· Villa Sistemi Medicali S.P.A.

Recalled Item: Apollo DRF Recalled by Villa Sistemi Medicali S.P.A. Due to An amendment to...

The Issue: An amendment to the IFU and Service Manual is being issued to prescribe the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 1, 2019· Bio-Rad Laboratories, Inc.

Recalled Item: BioPlex 2200 ANA Screen Control Set Recalled by Bio-Rad Laboratories, Inc....

The Issue: A new lot of ANA screen control and any subsequent control lots are...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 30, 2019· Teleflex Medical

Recalled Item: HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube - Product Recalled by...

The Issue: The tracheal and brochial swivel connectors are incorrectly labeled.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 30, 2019· Allergan PLC

Recalled Item: XEN Gel Stent Recalled by Allergan PLC Due to Foreign Object Contamination

The Issue: Residual polishing compounds, that are used in the needle sleeve...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 30, 2019· Young Dental Manufacturing Co, LLC

Recalled Item: Oral-B Recalled by Young Dental Manufacturing Co, LLC Due to Product shelf...

The Issue: Product shelf life may be shorter than that indicated on the label.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 29, 2019· Bio-Signal Group Corp.

Recalled Item: HydroDot brand: Wave Prep Single use cups Recalled by Bio-Signal Group Corp....

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 DeviceOctober 29, 2019· Bio-Signal Group Corp.

Recalled Item: HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive...

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 DeviceOctober 28, 2019· Cardinal Health 200, LLC

Recalled Item: Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013...

The Issue: The frequency of calibration for the Genius Tympanic Thermometer as stated...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2019· Roche Diagnostics Operations, Inc.

Recalled Item: Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of...

The Issue: Current software version of the Anti-HAV IgM APP-file (version 06.05-101)...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2019· Cardinal Health 200, LLC

Recalled Item: Genius 2 Tympanic Thermometer Private Label Item Code: 3069 Recalled by...

The Issue: The frequency of calibration for the Genius Tympanic Thermometer as stated...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2019· Cardinal Health 200, LLC

Recalled Item: Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063 Recalled by...

The Issue: The frequency of calibration for the Genius Tympanic Thermometer as stated...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2019· Cardinal Health 200, LLC

Recalled Item: Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000 Recalled by...

The Issue: The frequency of calibration for the Genius Tympanic Thermometer as stated...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 28, 2019· Smiths Medical ASD Inc.

Recalled Item: Medfusion Syringe Pump Recalled by Smiths Medical ASD Inc. Due to There is...

The Issue: There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0...

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

Class I — Serious Health HazardOngoing
Medical DeviceOctober 28, 2019· Cardinal Health 200, LLC

Recalled Item: Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062 Recalled by...

The Issue: The frequency of calibration for the Genius Tympanic Thermometer as stated...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 25, 2019· Bard Peripheral Vascular Inc

Recalled Item: BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The...

The Issue: During the firm's review of May 2019 complaint data, a significant increase...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 25, 2019· Conformis, Inc.

Recalled Item: iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 -...

The Issue: Medial and lateral polyethylene inserts did not securely fit into the cobalt...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 24, 2019· Boston Scientific Corporation

Recalled Item: Rebel Monorail PtCr Coronary Stent System Recalled by Boston Scientific...

The Issue: Certain dilation and extension catheters are being recalled because these...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 24, 2019· Applied Medical Resources Corp

Recalled Item: Python Embolectomy Catheters Recalled by Applied Medical Resources Corp Due...

The Issue: The firm has received reports of tip separation during usage of the...

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

Class I — Serious Health HazardOngoing