Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

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Date	Product	Reason	Class	Firm
Aug 5, 2013	Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic...	The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has be...	Class II	Toshiba American Medical Systems Inc
Aug 5, 2013	Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic...	The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has be...	Class II	Toshiba American Medical Systems Inc
Aug 5, 2013	3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product co...	3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these prod...	Class II	3M Company/3m Espe Dental Products
Aug 5, 2013	Outlook Safety Infusion System Burette Set. For intravenous fluid administ...	Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Pro...	Class II	B. Braun Medical, Inc.
Aug 2, 2013	Juno DRF System. Mobile X-ray system These are general, multi-function x-r...	It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro m...	Class II	Villa Radiology Systems LLC
Aug 2, 2013	Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50...	AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viabil...	Class II	Getinge USA Inc
Aug 1, 2013	00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, ...	Zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distracto...	Class II	Zimmer, Inc.
Aug 1, 2013	Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates e...	The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malf...	Class II	Synthes USA HQ, Inc.
Aug 1, 2013	NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1....	Under certain circumstances, the Left eye image may be saved as the Right eye image.	Class II	Nidek Inc
Jul 31, 2013	Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic image...	A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which include...	Class II	Fujinon Inc
Jul 31, 2013	PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS D...	Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i...	Class II	DePuy Spine, Inc.
Jul 31, 2013	Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiatio...	Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut...	Class II	Boston Scientific Corporation
Jul 31, 2013	"*Flo Trac Sensor Model MHD85*" Sterile, single use kit that monitors ...	The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance ...	Class II	Edwards Lifesciences, LLC
Jul 31, 2013	PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS D...	Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i...	Class II	DePuy Spine, Inc.
Jul 31, 2013	VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint config...	The product has the potential to be laser marked as a Medium when it actually is a Small.	Class II	Spine Smith Holdings, LLC
Jul 31, 2013	Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumb...	Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction I...	Class II	Synthes USA HQ, Inc.
Jul 31, 2013	2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixatio...	Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issu...	Class II	Synthes USA HQ, Inc.
Jul 31, 2013	Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leic...	The affected lots of the product may contain a contaminant of fungus that can cause a loss of sta...	Class II	Leica Biosystems Newcastle Ltd.
Jul 31, 2013	Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The ...	Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock state...	Class II	Arrow International Inc
Jul 31, 2013	Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irrad...	Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut...	Class II	Boston Scientific Corporation
Jul 31, 2013	Slipped Capital Femoral Epiphysis System Product Usage: Intended for fra...	There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to sti...	Class II	Synthes USA HQ, Inc.
Jul 31, 2013	PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dila...	Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i...	Class II	DePuy Spine, Inc.
Jul 31, 2013	PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holdi...	Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i...	Class II	DePuy Spine, Inc.
Jul 31, 2013	Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Lar...	The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints ...	Class II	Synthes USA HQ, Inc.
Jul 31, 2013	PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Di...	Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i...	Class II	DePuy Spine, Inc.
Jul 31, 2013	Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional...	All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction for...	Class II	Synthes USA HQ, Inc.
Jul 30, 2013	ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLAT...	Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, ...	Class II	Zimmer, Inc.
Jul 30, 2013	Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1...	Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concer...	Class II	Edwards Lifesciences, LLC
Jul 30, 2013	Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifr...	The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is et...	Class II	Synthes USA HQ, Inc.
Jul 30, 2013	Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for frac...	A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate.	Class II	Synthes (USA) Products LLC
Jul 30, 2013	Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fi...	Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect label...	Class II	Synthes USA HQ, Inc.
Jul 30, 2013	High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessor...	During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigati...	Class II	Smith & Nephew, Inc., Endoscopy Div.
Jul 30, 2013	Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product U...	Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series e...	Class II	Getinge Disinfection
Jul 30, 2013	Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-439...	Stryker received reports of the desiccant bag in the kit leaking silica gel granulate. This coul...	Class II	Stryker Craniomaxillofacial Division
Jul 30, 2013	Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product ...	The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are e...	Class II	Synthes USA HQ, Inc.
Jul 30, 2013	Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment...	The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole...	Class II	Synthes USA HQ, Inc.
Jul 30, 2013	Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable a...	Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the n...	Class II	Synthes USA HQ, Inc.
Jul 30, 2013	Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog n...	One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the produ...	Class II	Synergetics Inc
Jul 30, 2013	ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/US...	Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up t...	Class II	Siemens Healthcare Diagnostics
Jul 30, 2013	Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject P...	Complaints were received of inconsistencies in the expiration dates shown on the packaging of the...	Class II	Synthes USA HQ, Inc.
Jul 29, 2013	SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSI...	These products are being recalled because they were distributed without adequate labeling and ins...	Class II	Sarken, Inc.
Jul 29, 2013	SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC...	These products are being recalled because they were distributed without adequate labeling and ins...	Class II	Sarken, Inc.
Jul 29, 2013	SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC...	These products are being recalled because they were distributed without adequate labeling and ins...	Class II	Sarken, Inc.
Jul 29, 2013	SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENS...	These products are being recalled because they were distributed without adequate labeling and ins...	Class II	Sarken, Inc.
Jul 29, 2013	SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC...	These products are being recalled because they were distributed without adequate labeling and ins...	Class II	Sarken, Inc.
Jul 29, 2013	SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC...	These products are being recalled because they were distributed without adequate labeling and ins...	Class II	Sarken, Inc.
Jul 29, 2013	Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The D...	GE Healthcare has recently become aware of a potential safety issue involving the pre-operative c...	Class II	GE Healthcare, LLC
Jul 26, 2013	Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1...	The operators manual does not fully describe the sequence of expected events that will occur when...	Class II	Terumo Cardiovascular Systems Corporation
Jul 26, 2013	Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/...	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ...	Class II	ASO, LLC
Jul 26, 2013	Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in...	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ...	Class II	ASO, 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.