Browse Device Recalls
726 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 726 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 726 FDA device recalls in NC.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 10, 2026 | Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-153... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 10, 2026 | NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 10, 2026 | Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I,... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 10, 2026 | Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-1519... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| Mar 17, 2026 | Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, R... | Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting... | Class I | Medical Action Industries, Inc. 306 |
| Mar 11, 2026 | Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - ... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)108019022... | Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PU... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 ... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CAT... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOU... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)1... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters R... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 3, 2026 | Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO | Due to increased in complaints their is the potential for endoscopic clipping device to malfunct... | Class II | Wilson-Cook Medical Inc. |
| Feb 16, 2026 | Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm | Drainable large pouch may leak due to manufacturing issue. | Class II | ConvaTec, Inc |
| Feb 16, 2026 | Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm | Drainable large pouch may leak due to manufacturing issue. | Class II | ConvaTec, Inc |
| Feb 16, 2026 | Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm | Drainable large pouch may leak due to manufacturing issue. | Class II | ConvaTec, Inc |
| 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. |
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.