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Recalls distributed in North Carolina

These notices name North Carolina in the distribution list the company gave its agency. That list says where the product was shipped, not where it ended up — a recalled item can travel with a shopper, and some notices list no states at all.

4,689 stored notices name North Carolina, reported between Jun 20, 2012 and Sep 23, 2026. A further 48,122 notices were distributed nationwide, so they reach North Carolina too — those are in the archive.

Medical devices

Reported Jun 6, 2018

LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a.…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Torax Medical, Inc.

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 6, 2018

AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

WRP Asia Pacific Sdn Bhd

FDA (openFDA device enforcement)

Food

Reported Jun 6, 2018

Ziyad Brand Tahini, 8oz, 16oz, ¿ gal, 32oz. , packed in glass jars

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Ziyad Brothers Importing, Inc.

FDA (openFDA food enforcement)

Medical devices

Reported May 30, 2018

Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number:…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Edwards Lifesciences, LLC

FDA (openFDA device enforcement)

Food

Reported May 30, 2018

Southwestern Gourmet Butter Popcorn Grand Canyon Foods, Phoenix, AZ

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Grand Canyon Foods International LLC.

1 more product in this recall

FDA (openFDA food enforcement)

Medical devices

Reported May 30, 2018

ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Implant Direct Sybron Manufacturing, LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 30, 2018

Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #:…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

LivaNova USA

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 30, 2018

First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Madison Polymeric Engineering

5 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 30, 2018

smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Smith & Nephew, Inc.

5 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 30, 2018

AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Spinal Elements

FDA (openFDA device enforcement)

Medical devices

Reported May 30, 2018

Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Synthes (USA) Products LLC

FDA (openFDA device enforcement)

Medical devices

Reported May 23, 2018

Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Abbott

FDA (openFDA device enforcement)

Food

Reported May 23, 2018

DIABEATIC Chocolate Berry Crunch bar NET WT 1.4 oz (42g)Manufactured and Distributed by eBars, LLC, Franklin, TN 37064…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

eBars

12 more products in this recall

FDA (openFDA food enforcement)

Medical devices

Reported May 23, 2018

Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Tosoh Bioscience Inc.

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 23, 2018

Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Volcano Corporation

FDA (openFDA device enforcement)

Medical devices

Reported May 23, 2018

Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Zimmer Biomet, Inc.

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 16, 2018

ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Abbott GmbH & Co. KG

FDA (openFDA device enforcement)

Medical devices

Reported May 16, 2018

BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Datascope Corporation

27 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 16, 2018

Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Draeger Medical, Inc.

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 16, 2018

ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Hyphen BioMed

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 16, 2018

Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

ICU Medical, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 16, 2018

RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Mako Surgical Corporation

FDA (openFDA device enforcement)

Medical devices

Reported May 16, 2018

EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

MHC Medical Products LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 16, 2018

ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Siemens Medical Solutions USA, Inc.

FDA (openFDA device enforcement)

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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.