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. 2,724 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
2,724 in last 12 months

Showing 11011120 of 51,434 recalls

DrugOctober 9, 2025· Breckenridge Pharmaceutical, Inc.

Recalled Item: Duloxetine Delayed-Release Capsules Recalled by Breckenridge Pharmaceutical,...

The Issue: CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment...

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

Class II — Potential Health HazardOngoing
Refund
DrugOctober 9, 2025· USV Private Limited

Recalled Item: Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % Recalled by USV...

The Issue: Failed Impurities/Degradation Specifications: The result for 'Any individual...

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

Class II — Potential Health HazardOngoing
Refund
DrugOctober 9, 2025· Amerisource Health Services LLC

Recalled Item: Sucralfate Tablets Recalled by Amerisource Health Services LLC Due to CGMP...

The Issue: CGMP Deviations: The recalling firm filed for Chapter 11 on September 30,...

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

Class II — Potential Health HazardOngoing
Refund
DrugOctober 9, 2025· STAQ Pharma, Inc.

Recalled Item: Hydromorphone HCL PF Recalled by STAQ Pharma, Inc. Due to Labeling:...

The Issue: Labeling: Incorrect or Missing Lot and/or Exp Date

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

Class III — Low RiskOngoing
Refund
DrugOctober 9, 2025· STAQ Pharma, Inc.

Recalled Item: FentaNYL Citrate PF Recalled by STAQ Pharma, Inc. Due to Labeling: Incorrect...

The Issue: Labeling: Incorrect or Missing Lot and/or Exp Date

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

Class III — Low RiskOngoing
Refund
Medical DeviceOctober 9, 2025· C-RAD POSITIONING AB

Recalled Item: Brand Name: Catalyst+ Product Name: Catalyst Recalled by C-RAD POSITIONING...

The Issue: Due to issues with the system's stereotactic radiosurgery (SRS) treatment...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2025· Myofunctional Research Company USA

Recalled Item: Myosa for Kids KS1 /Sp/Mb/Mp/Lb/Lc KS2 /Sc/Mb/Mc/Mp/Lb/Lc Myosa Recalled by...

The Issue: Due to firm mistakenly distributing product within the U.S. without FDA...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2025· Pivotal Health Solutions, Inc.

Recalled Item: Quantum Intersegmental Table Recalled by Pivotal Health Solutions, Inc. Due...

The Issue: The heat function may become damaged over time due to patients pressing on...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2025· Pivotal Health Solutions, Inc.

Recalled Item: Quantum Intersegmental Table Recalled by Pivotal Health Solutions, Inc. Due...

The Issue: The heat function may become damaged over time due to patients pressing on...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2025· Thoratec LLC

Recalled Item: Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone)...

The Issue: Due to potential corrosion issues associated with the Backup Battery cable...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2025· Thoratec LLC

Recalled Item: Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone)...

The Issue: Due to potential corrosion issues associated with the Backup Battery cable...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2025· Thoratec LLC

Recalled Item: Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Recalled...

The Issue: Due to potential corrosion issues associated with the Backup Battery cable...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2025· Thoratec LLC

Recalled Item: Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System...

The Issue: Due to potential corrosion issues associated with the Backup Battery cable...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2025· B-K Medical A/S

Recalled Item: Ultrasound System 1300 Recalled by B-K Medical A/S Due to GE HealthCare has...

The Issue: GE HealthCare has become aware that the Instructions for Use within the user...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2025· B-K Medical A/S

Recalled Item: bk5000 Ultrasound System w/battery Recalled by B-K Medical A/S Due to GE...

The Issue: GE HealthCare has become aware that the Instructions for Use within the user...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2025· B-K Medical A/S

Recalled Item: UUltrasound System 2300 Recalled by B-K Medical A/S Due to GE HealthCare has...

The Issue: GE HealthCare has become aware that the Instructions for Use within the user...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2025· B-K Medical A/S

Recalled Item: 1202 Flex Focus Ultrasound System Recalled by B-K Medical A/S Due to GE...

The Issue: GE HealthCare has become aware that the Instructions for Use within the user...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2025· B-K Medical A/S

Recalled Item: bk3000 Ultrasound System w/battery Recalled by B-K Medical A/S Due to GE...

The Issue: GE HealthCare has become aware that the Instructions for Use within the user...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2025· B-K Medical A/S

Recalled Item: bk3500 Ultrasound System w/battery Recalled by B-K Medical A/S Due to GE...

The Issue: GE HealthCare has become aware that the Instructions for Use within the user...

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

Class II — Potential Health HazardOngoing
DrugOctober 8, 2025· Mohamed Hagar

Recalled Item: Mojo Max Fusion XXX Recalled by Mohamed Hagar Due to Undeclared Sildenafil

The Issue: Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared...

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

Class I — Serious Health HazardOngoing
Refund