Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

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Date	Product	Reason	Class	Firm
Nov 8, 2016	PRO-STIM 10cc INJECTABLE, Part Number 86SR0410	The firm discovered a lack of adequate documentation confirming sterility on certain products.	Class II	Wright Medical Technology, Inc.
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
Nov 7, 2016	MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses ...	Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Integ...	Class II	Bayer Healthcare
Nov 7, 2016	Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte,...	Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies ...	Class II	Exactech, Inc.
Nov 7, 2016	Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.	The device defect associated with this recall may result in HbA1c values with a negative bias in ...	Class II	Tosoh Bioscience, Inc.
Nov 7, 2016	The Hemotherm 400CE 115v, containing power board p/n 39945	The device may not maintain water flow or temperature control.	Class II	Cincinnati Sub-Zero Products Inc
Nov 7, 2016	PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only,...	DeRoyal received complaints of mold on Tennis Elbow Straps.	Class II	DeRoyal Industries Inc
Nov 7, 2016	Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6	Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies ...	Class II	Exactech, Inc.
Nov 7, 2016	Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase I...	Due to a customer experiencing complaints on bone fraction of assay not being in range. The co...	Class III	Helena Laboratories, Inc.
Nov 7, 2016	AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +...	Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies ...	Class II	Exactech, Inc.
Nov 7, 2016	BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use ...	BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, l...	Class II	Becton Dickinson & Company
Nov 7, 2016	TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Onl...	DeRoyal received complaints of mold on Tennis Elbow Straps.	Class II	DeRoyal Industries Inc
Nov 7, 2016	Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6...	Firm received reports about "acquisition errors" and the deterioration of material covering the a...	Class II	Siemens Medical Solutions USA, Inc.
Nov 4, 2016	MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool ...	The firm failed to notify current customers of IFU update/warning. During a recent FDA inspection...	Class II	Thayer Intellectual Property, Inc.
Nov 3, 2016	VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M...	Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Univ...	Class II	Voco GmbH
Nov 3, 2016	GE Healthcare, Avance, Avance CS2, Amingo.	GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and A...	Class II	GE Healthcare, LLC
Nov 3, 2016	Monaco RTP System; Used to make treatment plans for patients with prescriptio...	Incorrect Dose when using the reset function.	Class II	Elekta, Inc.
Nov 3, 2016	HF Cable WA00014A, Endoscopic electrosurgical unit and accessories	Software malfunction that results in incorrect generation or display of error codes.	Class II	Olympus Corporation of the Americas
Nov 3, 2016	Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.	Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System b...	Class II	Terumo BCT, Inc.
Nov 2, 2016	SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM ...	Siemens is releasing a software update that provides bug-fixes to improve system performance for ...	Class II	Siemens Medical Solutions USA, Inc
Nov 2, 2016	SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATO...	Siemens is releasing a software update that provides bug-fixes to improve system performance for ...	Class II	Siemens Medical Solutions USA, Inc
Nov 2, 2016	SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMAT...	Siemens is releasing a software update that provides bug-fixes to improve system performance for ...	Class II	Siemens Medical Solutions USA, Inc
Nov 1, 2016	AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems ...	The possibility exists that the semi-automatic focus switch may not work as intended when pressin...	Class II	Siemens Medical Solutions USA, Inc
Nov 1, 2016	IVEA 500A Intended for Med-Surg patient care.	The dowel pin could potentially slip out of its press fit, resulting in the product potentially s...	Class II	Firefly Medical, Inc.
Nov 1, 2016	Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis syste...	The possibility exists that the semi-automatic focus switch may not work as intended when pressin...	Class II	Siemens Medical Solutions USA, Inc
Nov 1, 2016	Alaris System PC unit, model no. 8000 and 8015. The central programming, mon...	Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered bef...	Class II	CareFusion 303, Inc.
Nov 1, 2016	Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a...	The possibility exists that the semi-automatic focus switch may not work as intended when pressin...	Class II	Siemens Medical Solutions USA, Inc
Nov 1, 2016	Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile	Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm ...	Class II	Synthes (USA) Products LLC
Oct 31, 2016	ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The...	iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).	Class II	ConforMIS, Inc.
Oct 31, 2016	ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-00...	Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Cath...	Class II	Spectranetics Corporation
Oct 31, 2016	CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102...	20 Pumps sold to the Finnish market contain a message in which one word in the message is mistran...	Class II	Smiths Medical ASD, Inc.
Oct 31, 2016	Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2...	Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Pr...	Class II	Owens & Minor Distribution, Inc.
Oct 31, 2016	Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159,...	Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Cath...	Class II	Spectranetics Corporation
Oct 31, 2016	HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotl...	HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the requir...	Class III	Smiths Medical ASD, Inc.
Oct 31, 2016	Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible...	Non-conforming material used.	Class II	Synthes (USA) Products LLC
Oct 31, 2016	Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the s...	Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Cath...	Class II	Spectranetics Corporation
Oct 31, 2016	MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: coba...	Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and ca...	Class II	Roche Diagnostics Operations, Inc.
Oct 31, 2016	Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Per...	Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve ...	Class II	Sorin Group USA, Inc.
Oct 31, 2016	MEVION S250 Product Usage: Proton Radiation Therapy	Completing Setup Without Program Move Complete Can Cause An Isocenter Error	Class II	Mevion Medical Systems, Inc.
Oct 28, 2016	12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usag...	IBA is initiating this recall to address an issue identified with AdaPTinsight software and to re...	Class II	Ion Beam Applications S.A.
Oct 28, 2016	Gomco Circumcision Clamps with separate O-Ring Component: The device is packa...	Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.	Class II	Aesculap Implant Systems LLC
Oct 28, 2016	SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. ...	Breach in sterile barrier compromising product sterility	Class II	Hologic, Inc
Oct 28, 2016	Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, L...	A change in the calibration curve causing an increase in false prozone flags.	Class II	The Binding Site Group, Ltd.
Oct 28, 2016	Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved...	The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate c...	Class II	Integra York PA, Inc
Oct 28, 2016	Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pea...	The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate c...	Class II	Integra York PA, Inc
Oct 28, 2016	Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to...	neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recal...	Class II	Natus Medical Incorporated
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	Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analy...	Possible unintentional x-ray emission after users attempt early termination of the sequence.	Class II	Olympus Scientific Solutions Americas
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

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.