Browse Device Recalls

709 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 709 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 709 FDA device recalls in NC.

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DateProductReasonClassFirm
Dec 18, 2025 Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784... Due to product that may contain a void in the material that separates the wire guide and cutting ... Class II Wilson-Cook Medical Inc.
Dec 15, 2025 Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 Nasal feeding tube packaged without the nasal transfer tube component. Class II Wilson-Cook Medical Inc.
Nov 18, 2025 Intelerad InteleShare software, with ProViewer component Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical st... Class II DICOM Grid, Inc.
Sep 4, 2025 Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Int... Carotid stent and post-dilation balloon system with integrated embolic protection system has an i... Class II Contego Medical LLC
Aug 29, 2025 DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressi... Wound dressing may have foreign matter on the product. Class II ConvaTec, Inc
Aug 19, 2025 Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator ... Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel sepa... Class II Greiner Bio-One North America, Inc.
Aug 8, 2025 Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 Blood collection tubes were manufactured with the label applied too high on the tube, which shif... Class II Greiner Bio-One North America, Inc.
Aug 4, 2025 Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Mo... Two new potential laser safety failure modes have been identified in the product design. Overcurr... Class II WASATCH PHOTONICS
Jun 26, 2025 VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation ... Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas ... Class II bioMerieux, Inc.
Nov 29, 2024 Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a t... Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut... Class II ConvaTec, Inc
Oct 31, 2024 Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, ste... Specific lots of product have been manufactured with nonconforming raw materials resulting in the... Class II Wilson-Cook Medical Inc.
Sep 3, 2024 Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a st... The patient label stickers may have the wrong expiration date recorded. The contract manufacturer... Class III Trackx Technology Inc
Aug 29, 2024 Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Steril... Specific lots of product have been manufactured with nonconforming raw materials. Class II Wilson-Cook Medical Inc.
Aug 27, 2024 Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-3... Incorrect expiration date. Class II Safeguard US Operating LLC
Aug 27, 2024 HAWK Warming Grid, Item Number: 59-300 Incorrect expiration date. Class II Safeguard US Operating LLC
Aug 27, 2024 HAWK Advanced Hypothermia Management Set, Item Number: 59-320 Incorrect expiration date. Class II Safeguard US Operating LLC
Jul 26, 2024 Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray w... Reports have been received regarding open seals on the packaging. Class II ARROW INTERNATIONAL Inc.
Jun 11, 2024 Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each ... The protective pouches were identified to have been improperly labeled with UDI that is associate... Class II Medical Action Industries, Inc. 306
May 14, 2024 VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow... The firm received reports that some blood collection tubes have experienced issues with clotting ... Class II Greiner Bio-One North America, Inc.
May 13, 2024 Non-sterile, single use, disposable gloves intended for medical purposes to b... Firm received complaints regarding skin irritation when using the gloves, disintegration of the g... Class II SVS LLC
Apr 29, 2024 Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b)... Teleflex received reports indicating an infrequent condition that, when not identified and correc... Class I ARROW INTERNATIONAL Inc.
Apr 29, 2024 Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) R... Teleflex received reports indicating an infrequent condition that, when not identified and correc... Class I ARROW INTERNATIONAL Inc.
Apr 29, 2024 Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; ... Teleflex received reports indicating an infrequent condition that, when not identified and correc... Class I ARROW INTERNATIONAL Inc.
Feb 27, 2024 ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Contro... The product does not meet sterility assurance level. Class II ConvaTec, Inc
Feb 19, 2024 Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 42... Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the E... Class II ConvaTec, Inc
Feb 12, 2024 ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Nu... Teleflex is initiating this voluntary recall for the above-mentioned products due to reports rece... Class I ARROW INTERNATIONAL Inc.
Jan 17, 2024 ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 4169... The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for... Class II ConvaTec, Inc
Jan 15, 2024 IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Ster... The kits contain saline flush syringes which were recalled by the supplier. Class II Medical Action Industries, Inc. 306
Dec 12, 2023 VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 ... Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clott... Class II Greiner Bio-One North America, Inc.
Nov 3, 2023 QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; use... Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... Class II Wilson-Cook Medical Inc.
Nov 3, 2023 QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; us... Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... Class II Wilson-Cook Medical Inc.
Nov 3, 2023 QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used ... Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... Class II Wilson-Cook Medical Inc.
Nov 3, 2023 QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used... Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... Class II Wilson-Cook Medical Inc.
Nov 3, 2023 QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; use... Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... Class II Wilson-Cook Medical Inc.
Nov 3, 2023 QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used ... Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... Class II Wilson-Cook Medical Inc.
Nov 3, 2023 QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used ... Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... Class II Wilson-Cook Medical Inc.
Sep 15, 2023 Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ... Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Sur... Class I Asensus Surgical Inc
Aug 10, 2023 Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854... This recall has been initiated due to reports that the product code and product name were incorre... Class I ARROW INTERNATIONAL Inc.
Aug 10, 2023 Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pr... This recall has been initiated due to reports that the product code and product name were incorre... Class I ARROW INTERNATIONAL Inc.
Aug 10, 2023 Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen... This recall has been initiated due to reports that the product code and product name were incorre... Class I ARROW INTERNATIONAL Inc.
Aug 10, 2023 Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS ... This recall has been initiated due to reports that the product code and product name were incorre... Class II ARROW INTERNATIONAL Inc.
Aug 10, 2023 Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC p... This recall has been initiated due to reports that the product code and product name were incorre... Class I ARROW INTERNATIONAL Inc.
Aug 10, 2023 Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; cathe... This recall has been initiated due to reports that the product code and product name were incorre... Class II ARROW INTERNATIONAL Inc.
Jun 26, 2023 Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software Software issue Class II Digisonics, Inc
Jun 22, 2023 Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion... Non-conforming product may appear in the field as inability to advance or retract the basket, or ... Class II Wilson-Cook Medical Inc.
Jun 22, 2023 Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion ... Non-conforming product may appear in the field as inability to advance or retract the basket, or ... Class II Wilson-Cook Medical Inc.
May 25, 2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cu... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cu... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 1700100 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.