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. 1,152 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
1,152 in last 12 months

Showing 7101–7120 of 51,434 recalls

DrugDecember 28, 2023· Fresenius Medical Care Holdings, Inc.

Recalled Item: DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose...

The Issue: Lack of Sterility Assurance

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugDecember 28, 2023· Denver Solutions, LLC DBA Leiters Health

Recalled Item: VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag Recalled...

The Issue: Superpotent Drug: semi-automated IV bag filling system can malfunction and...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
DrugDecember 28, 2023· Denver Solutions, LLC DBA Leiters Health

Recalled Item: PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL)...

The Issue: Superpotent Drug: semi-automated IV bag filling system can malfunction and...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
DrugDecember 28, 2023· Denver Solutions, LLC DBA Leiters Health

Recalled Item: VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag Recalled...

The Issue: Superpotent Drug: semi-automated IV bag filling system can malfunction and...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
Medical DeviceDecember 27, 2023· Abiomed, Inc.

Recalled Item: Impella catheters - Intravascular micro axial blood pumps that support...

The Issue: New warnings are being added to the Instructions for Use for all affected...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 27, 2023· Abiomed, Inc.

Recalled Item: Impella catheters - Intravascular micro axial blood pumps that support...

The Issue: IFU has been updated to include warnings about the risk of the inlet...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 27, 2023· TruAbutment Inc.

Recalled Item: Brand Name: TruScan Body Recalled by TruAbutment Inc. Due to Retroactive:...

The Issue: Retroactive: Due to defect and quality issues dental scanner may not scan...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 26, 2023· Ossur H / F

Recalled Item: Power Knee Recalled by Ossur H / F Due to Knee batteries may need...

The Issue: Knee batteries may need replacement with conforming batteries to ensure...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 26, 2023· GE Medical Systems, SCS

Recalled Item: Senographe Pristina Recalled by GE Medical Systems, SCS Due to X-ray...

The Issue: X-ray exposure termination audible signal on Senographe Pristina with...

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

Class II — Potential Health HazardOngoing
DrugDecember 26, 2023· Amneal Pharmaceuticals of New York, LLC

Recalled Item: Divalproex Sodium Extended-release Tablets Recalled by Amneal...

The Issue: Failed dissolution specifications

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugDecember 26, 2023· Haleon US Holdings LLC

Recalled Item: Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg Recalled by...

The Issue: Microbial Contamination of Non-Sterile Products

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
DrugDecember 26, 2023· Amerisource Health Services LLC

Recalled Item: Benzonatate Capsules Recalled by Amerisource Health Services LLC Due to...

The Issue: Superpotent drug: Assay results were slightly above specification at the...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugDecember 26, 2023· Haleon US Holdings LLC

Recalled Item: Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg Recalled by...

The Issue: Microbial Contamination of Non-Sterile Products

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
Medical DeviceDecember 22, 2023· Howmedica Osteonics Corp.

Recalled Item: HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use...

The Issue: Failed to meet the acceptance criteria for the seal integrity and/or package...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2023· Howmedica Osteonics Corp.

Recalled Item: HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use Recalled by...

The Issue: Failed to meet the acceptance criteria for the seal integrity and/or package...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2023· Onkos Surgical, Inc.

Recalled Item: ELEOS COLLAR STEM Recalled by Onkos Surgical, Inc. Due to Mislabeling

The Issue: Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2023· Onkos Surgical, Inc.

Recalled Item: ELEOS COLLAR STEM Recalled by Onkos Surgical, Inc. Due to Mislabeling

The Issue: Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2023· AMD Medicom Inc.

Recalled Item: HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)...

The Issue: Level 3 masks were produced on alternate non-validated production equipment...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2023· Covidien LP

Recalled Item: Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT...

The Issue: Specific lots of sutures were sterilized with gamma doses that exceeded the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2023· Ivoclar Vivadent, Inc.

Recalled Item: Article No. NA6050411 Recalled by Ivoclar Vivadent, Inc. Due to Affected...

The Issue: Affected product may not perform as expected; the amalgam powder may not...

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

Class II — Potential Health HazardOngoing