Browse Device Recalls

774 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 774 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 774 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jan 20, 2017	Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 2002...	The firm information that the product was reporting false positive results	Class II	Gibson Laboratories LLC
Dec 16, 2016	IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spec...	Multiple issues have caused the device to result in CT rescans or incorrect scan location or misr...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 15, 2016	Boston Scientific Imager II Angiographic Catheter, a pathway for delivering c...	A field report indicated some units within this lot were missing the bottom pouch seal. The comp...	Class II	Boston Scientific Corporation
Nov 29, 2016	symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C1313...	Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid...	Class II	Symmetry Surgical, Inc.
Nov 29, 2016	symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134...	Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid...	Class II	Symmetry Surgical, Inc.
Nov 29, 2016	symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C1...	Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid...	Class II	Symmetry Surgical, Inc.
Oct 26, 2016	3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Univer...	3M is recalling Universal Electrosurgical Pads because a report of an unintended material (proces...	Class II	3M Company - Health Care Business
Oct 12, 2016	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCR...	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.	Class II	DePuy Spine, Inc.
Oct 12, 2016	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW ...	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.	Class II	DePuy Spine, Inc.
Oct 12, 2016	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCRE...	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.	Class II	DePuy Spine, Inc.
Oct 12, 2016	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SC...	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.	Class II	DePuy Spine, Inc.
Oct 12, 2016	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCRE...	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.	Class II	DePuy Spine, Inc.
Oct 12, 2016	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING ...	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.	Class II	DePuy Spine, Inc.
Oct 12, 2016	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCR...	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.	Class II	DePuy Spine, Inc.
Oct 6, 2016	The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, infla...	AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device ...	Class II	AccessClosure, Inc., A Cardinal Health Company
Sep 29, 2016	Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 1...	The insert and case label description of the device incorrectly reads Counter Incrementing Actuat...	Class II	Thayer Medical Corporation
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
Aug 16, 2016	Pathfast D-Dimer, Reference number: PF1051-KUS	Two complaints were received about decrease in sensitivity (control value and/or calibration valu...	Class II	Lsi Medience Corporation
Aug 12, 2016	Medtronic, Evera Implantable Cardioverter Defibrillators: Product Mo...	78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failure
Aug 12, 2016	Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product...	78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failure
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	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	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 15, 2016	Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOP...	Quality control identified a component issue where the pinion gear in the device could fail under...	Class II	Ethicon Endo-Surgery Inc
Jul 15, 2016	Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH E...	Quality control identified a component issue where the pinion gear in the device could fail under...	Class II	Ethicon Endo-Surgery Inc
Jun 30, 2016	Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of ...	Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t...	Class II	Stryker Howmedica Osteonics Corp.
Jun 30, 2016	Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intend...	Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t...	Class II	Stryker Howmedica Osteonics Corp.
Jun 10, 2016	Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vi...	An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in thi...	Class II	Dako North America Inc.
May 6, 2016	Ariol is an automated scanning microscope and image analysis system. It is in...	An issue during the manufacturing process caused systems to have an improperly activated Windows ...	Class III	Leica Biosystems Richmond Inc.
Mar 31, 2016	Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog...	Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some ...	Class III	Biocare Medical, LLC
Mar 28, 2016	Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar C...	Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with L...	Class II	Becton Dickinson & Co.
Mar 25, 2016	The Plum 360 is a large volume infuser capable of delivering fluids for a var...	Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were att...	Class II	Hospira Inc.
Feb 16, 2016	Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retrac...	Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retract...	Class II	Biomet, Inc.
Feb 12, 2016	BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, ...	BD has confirmed that a portion of BD SurePath" collection vials associated with specific product...	Class II	Becton Dickinson & Co.
Jan 11, 2016	VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, ...	LDPE bag containing the implant adheres to the highly polished implant surface.	Class II	Zimmer Biomet, Inc.
Jan 11, 2016	Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, ceme...	LDPE bag containing the implant adheres to the highly polished implant surface.	Class II	Zimmer Biomet, Inc.
Jan 11, 2016	VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, ...	LDPE bag containing the implant adheres to the highly polished implant surface.	Class II	Zimmer Biomet, Inc.
Jan 11, 2016	VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, ...	LDPE bag containing the implant adheres to the highly polished implant surface.	Class II	Zimmer Biomet, Inc.
Jan 11, 2016	VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC...	LDPE bag containing the implant adheres to the highly polished implant surface.	Class II	Zimmer Biomet, Inc.
Jan 8, 2016	Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localizati...	Product potentially exposed to body fluids during processing. Potential adverse events that may ...	Class II	Cook Inc.
Dec 1, 2015	CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively...	Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood...	Class II	Partners In Medicine Llc
Nov 20, 2015	IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Numbe...	During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ...	Class II	Boston Scientific Corp
Nov 20, 2015	IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Numbe...	During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ...	Class II	Boston Scientific Corp
Nov 20, 2015	IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: ...	During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ...	Class II	Boston Scientific Corp
Nov 20, 2015	IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M00...	During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ...	Class II	Boston Scientific Corp
Oct 23, 2015	GE Healthcare, Revolution CT Scanners. Revolution CT- The system is inte...	GE Healthcare has recently become aware of a potential issue with routine head scans on your Revo...	Class II	GE Medical Systems, LLC
Oct 9, 2015	RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev...	Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque...	Class I	Boston Scientific Corporation
Oct 9, 2015	RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev...	Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque...	Class I	Boston Scientific Corporation
Oct 6, 2015	Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path	Leakage from the inlet port of the 15L Cycler Drainage Bags.	Class II	Baxter Healthcare Corp.

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.