Product Recalls in North Carolina

Product recalls affecting North Carolina — including food, drugs, consumer products, medical devices, and vehicles distributed to North Carolina. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 1,042 recalls have been distributed to North Carolina in the last 12 months.

54,363 total recalls
1,042 in last 12 months

Showing 18861–18880 of 54,363 recalls

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· 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 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
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 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-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 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
DrugSeptember 3, 2020· CORGIOMED LLC

Recalled Item: Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v) Recalled by...

The Issue: Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol...

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

Class I — Serious 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
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
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
Medical DeviceSeptember 1, 2020· Fresenius Medical Care Holdings, Inc.

Recalled Item: AquaBplus and AquaBplus B2 Water Purification System. For use with Recalled...

The Issue: Incorrectly crimped connectors were installed on the main protective earth...

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

Class II — Potential Health HazardOngoing
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· 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· Encore Medical, LP

Recalled Item: AltiVate Reverse Small Socket Insert Recalled by Encore Medical, LP Due to...

The Issue: Product mislabeled. Use may result in a delay in surgery, stopping of...

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

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

Recalled Item: Langston Dual Lumen Catheter. Recalled by Vascular Solutions, Inc. Due to...

The Issue: The inner lumen of the Langston catheter may separate from the hub during...

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

Class I — Serious Health HazardOngoing
Medical DeviceAugust 31, 2020· Vascular Solutions, Inc.

Recalled Item: Langston Dual Lumen Catheter Recalled by Vascular Solutions, Inc. Due to The...

The Issue: The inner lumen of the Langston catheter may separate from the hub during...

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

Class I — Serious Health HazardOngoing
Medical DeviceAugust 31, 2020· Olympus Corporation of the Americas

Recalled Item: Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to...

The Issue: The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the...

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: Spinning Spiros Recalled by ICU Medical, Inc. Due to Potential for spinning...

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
Medical DeviceAugust 31, 2020· ICU Medical, Inc.

Recalled Item: 5 IN (13 cm) Appx 1.5 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