Browse Device Recalls

712 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 712 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 712 FDA device recalls in NC.

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DateProductReasonClassFirm
Apr 21, 2017 PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Cat... Labeling: The expiration date is not stated on the labeling, there is a potential for expired pro... Class II Teleflex Medical
Apr 21, 2017 PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter C... Labeling: The expiration date is not stated on the labeling, there is a potential for expired pro... Class II Teleflex Medical
Apr 19, 2017 Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Tow... Lint present on sterile Operating Room Towels. Class II Medical Action Industries Inc
Apr 19, 2017 White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Inte... Lint present on sterile Operating Room Towels. Class II Medical Action Industries Inc
Apr 10, 2017 eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intend... Some anomalies have been identified during manufacturing controls. Class II bioMerieux, Inc.
Mar 29, 2017 Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079. Some of the individual unit packaging (pouches) may be missing the lot number an expiration date. Class III Teleflex Medical
Mar 24, 2017 WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, ... Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visi... Class II Teleflex Medical
Jan 30, 2017 LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx... Labeling: The labeled storage temperature is not consistent with the temperature conditions teste... Class II Tearscience, Inc
Jan 13, 2017 Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130... Labeling error Class II Teleflex Medical
Jan 10, 2017 Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intuba... The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as c... Class II Teleflex Medical
Nov 22, 2016 RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 ... Labeling Inconsistency: The products have been labeled with the incorrect expiration date which ... Class II Teleflex Medical
Nov 18, 2016 WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medica... Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured. Class II Teleflex Medical
Nov 16, 2016 Weck Facial Closure Systems have application in laparoscopic procedures for ... The devices wings may become partially detached from the EFx Shield during use. Class II Teleflex Medical
Nov 8, 2016 ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow On... Sterility: Due to a potential incomplete seal on the outer sterile package. Class II Teleflex Medical
Nov 8, 2016 ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Ar... Sterility: Due to a potential incomplete seal on the outer sterile package. Class II Teleflex Medical
Nov 8, 2016 OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnCon... Sterility: Due to a potential incomplete seal on the outer sterile package. Class II Teleflex Medical
Nov 8, 2016 ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow ... Sterility: Due to a potential incomplete seal on the outer sterile package. Class II Teleflex Medical
Nov 8, 2016 ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufacture... Sterility: Due to a potential incomplete seal on the outer sterile package. Class II Teleflex Medical
Oct 27, 2016 LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: ... Product Defect; These products may produce a straight stream instead of a fully atomized plume of... Class II Teleflex Medical
Oct 27, 2016 FLEXI NOZZLE SHORT Product Usage: These products are used for the deliver... Product Defect; These products may produce a straight stream instead of a fully atomized plume of... Class II Teleflex Medical
Oct 27, 2016 FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These product... Product Defect; These products may produce a straight stream instead of a fully atomized plume of... Class II Teleflex Medical
Oct 27, 2016 LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Produc... Product Defect; These products may produce a straight stream instead of a fully atomized plume of... Class II Teleflex Medical
Oct 27, 2016 LMA MADdy, Rx only, Product Usage: These products are used for the deliv... Product Defect; These products may produce a straight stream instead of a fully atomized plume of... Class II Teleflex Medical
Oct 27, 2016 LMA MADomizer, Rx only, Product Usage: These products are used for the d... Product Defect; These products may produce a straight stream instead of a fully atomized plume of... Class II Teleflex Medical
Oct 27, 2016 Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with ... Product Defect; These products may produce a straight stream instead of a fully atomized plume of... Class II Teleflex Medical
Oct 18, 2016 Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed ... Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units l... Class II Teleflex Medical
Sep 20, 2016 CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syring... Sterility of syringe product could not be assured. Class II Custom Medical Specialties, Inc.
Sep 13, 2016 LipiFlow thermal Pulsation System, consisting of Console and Activator, Model... Complaints related to an error condition occurring during patient treatment where the FipiFlow Sy... Class II Tearscience, Inc
Sep 13, 2016 ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US,... Customers complained of low/empty reagent vials. Class II TEM Systems Inc
Sep 9, 2016 Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile ... The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johan... Class II Teleflex Medical
Sep 9, 2016 Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile... The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johan... Class II Teleflex Medical
Aug 26, 2016 Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patie... The connector may disconnect from the tracheostomy tube during use. Class I Teleflex Medical
Aug 24, 2016 WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horiz... Misbranded: Incorrect etching on the device. Class II Teleflex Medical
Jul 25, 2016 Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance... The batteries have the potential to overheating, melt or char. Class II Tecan US, Inc.
Jul 25, 2016 Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate ... The batteries have the potential to overheating, melt or char. Class II Tecan US, Inc.
Jul 25, 2016 Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The... The batteries have the potential to overheating, melt or char. Class II Tecan US, Inc.
Jul 25, 2016 Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader fo... The batteries have the potential to overheating, melt or char. Class II Tecan US, Inc.
Jul 25, 2016 Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochrom... The batteries have the potential to overheating, melt or char. Class II Tecan US, Inc.
Jul 25, 2016 Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional m... The batteries have the potential to overheating, melt or char. Class II Tecan US, Inc.
Jul 25, 2016 SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance read... The batteries have the potential to overheating, melt or char. Class II Tecan US, Inc.
Jul 18, 2016 NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X... Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had ... Class II Aribex Inc
Jul 18, 2016 NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged... Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had ... Class II Aribex Inc
May 20, 2016 Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Mer... Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle. Class II Merz North America, Inc.
May 16, 2016 Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients... Product had torn/loose seal around the mouthpiece. Class II FSC Laboratories, Inc
May 5, 2016 Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.... The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a... Class II Teleflex Medical
Apr 26, 2016 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolyt... The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride a... Class II Greiner Bio-One North America, Inc.
Mar 30, 2016 Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08... The label on the Tyvek bag is missing. This is used by customers to identify material code, lot ... Class II Teleflex Medical
Mar 24, 2016 Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is ... Incorrect expiration date was printed on the product label. Class II Teleflex Medical
Mar 8, 2016 Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The produc... The firm received two customer complaints local Pelton & Crane distributors that the Helios 3000 ... Class II Pelton & Crane / Marus / DCI Equipment / KaVo
Feb 18, 2016 ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diag... Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA i... Class II TEM Systems 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.