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. 1,065 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
1,065 in last 12 months

Showing 17961–17980 of 51,434 recalls

FoodSeptember 5, 2020· COOLHAUS

Recalled Item: Coolhaus Awesome Ice Cream -That Dough Though Ice Cream Sandwich Recalled by...

The Issue: Package label does not declare soy lecithin.

Recommended Action: Do not consume. Return to store for a refund or discard.

Class II — Potential Health HazardOngoing
Refund
Medical DeviceSeptember 4, 2020· Biomet, Inc.

Recalled Item: Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055 Recalled by...

The Issue: Product not properly being aligned with the adequate gamma sterilization...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2020· AB ULAX

Recalled Item: 1500 Flex Heat and Moisture Exchanger Recalled by AB ULAX Due to Firm has...

The Issue: Firm has received 6 complaints that the Heat Moisture Exchanger (HME)...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2020· Braxton Medical Corporation

Recalled Item: B. Braun Introcan IV Safety Catheters Recalled by Braxton Medical...

The Issue: Recalled products do not have FDA approval for sale in the United States.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2020· Biomet, Inc.

Recalled Item: Biomet Regenerex Primary Taper Cap Item Number 141269 Recalled by Biomet,...

The Issue: Product not properly being aligned with the adequate gamma sterilization...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2020· Biomet, Inc.

Recalled Item: Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055 Recalled by Biomet, Inc....

The Issue: Product not properly being aligned with the adequate gamma sterilization...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2020· Biomet, Inc.

Recalled Item: Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050 Recalled by Biomet,...

The Issue: Product not properly being aligned with the adequate gamma sterilization...

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

Class II — Potential Health HazardOngoing
DrugSeptember 4, 2020· Teva Pharmaceuticals USA

Recalled Item: Buprenorphine Transdermal System 5 mcg/hour Recalled by Teva Pharmaceuticals...

The Issue: Failed Stability Specifications: Below specification result for...

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 3, 2020· Akorn, Inc.

Recalled Item: Eye Itch Relief Recalled by Akorn, Inc. Due to CGMP Deviations

The Issue: CGMP Deviations

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceSeptember 3, 2020· Biomet, Inc.

Recalled Item: (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar...

The Issue: Zimmer Biomet is conducting a medical device recall for three lots of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 2, 2020· Biomet, Inc.

Recalled Item: Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper...

The Issue: Product potentially being packaged without a taper adapter or baseplate. The...

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

Class II — Potential Health HazardOngoing
DrugSeptember 2, 2020· pH-D Feminine Health

Recalled Item: pH-D Feminine Health Boric Acid Vaginal Suppositories Recalled by pH-D...

The Issue: Marketed without an Approved NDA/ANDA.

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 1, 2020· The Protein Shoppe

Recalled Item: Red-E Tablet Recalled by The Protein Shoppe Due to Marketed Without An...

The Issue: Marketed Without An Approved NDA/ANDA: product found to be tainted with...

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

Class I — Serious Health HazardOngoing
Refund
Medical DeviceAugust 31, 2020· Cook Inc.

Recalled Item: Pediatric Nephrostomy Stent Set Recalled by Cook Inc. Due to The indwell...

The Issue: The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Cook Inc.

Recalled Item: Percutaneous Neonatal Pigtail Nephrostomy Set Recalled by Cook Inc. Due to...

The Issue: The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Brainlab AG

Recalled Item: Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for...

The Issue: Brainlab Ultrasound Navigation Software does not support the modification of...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001...

The Issue: Potential for Fluid leaks within the instruments, creating an electrical...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Ultradent Products, Inc.

Recalled Item: PermaFlo Flowable Composite 948 Shade: A2 - Product Usage: Recalled by...

The Issue: Due to a potential manufacturing issue (cross contamination), composite is...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Olympus Corporation of the Americas

Recalled Item: Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope...

The Issue: The BF-Q180 bronchoscope is being recalled because it does not have a 510(k)...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· ICU Medical, Inc.

Recalled Item: 30" (76 cm) Appx 3.3 ml Recalled by ICU Medical, Inc. Due to Potential for...

The Issue: Potential for spinning versions of male luers to exhibit leaks due to a...

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

Class II — Potential Health HazardOngoing