Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

Date	Product	Reason	Class	Firm
Dec 29, 2017	INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM	During an examination a device error occurred and the ceiling drive operation was disabled. It wa...	Class II	Toshiba American Medical Systems Inc
Dec 29, 2017	INFX-8000H Fluoroscopic X-Ray Systems	During an examination a device error occurred and the ceiling drive operation was disabled. It wa...	Class II	Toshiba American Medical Systems Inc
Dec 29, 2017	INFX-8000F Fluoroscopic X-Ray Systems	During an examination a device error occurred and the ceiling drive operation was disabled. It wa...	Class II	Toshiba American Medical Systems Inc
Dec 29, 2017	INFX-8000C Fluoroscopic X-Ray Systems	During an examination a device error occurred and the ceiling drive operation was disabled. It wa...	Class II	Toshiba American Medical Systems Inc
Dec 28, 2017	NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile	Potential for stylet to protrude from the distal end of the catheter	Class II	Epimed International
Dec 28, 2017	HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: ...	Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for us...	Class II	Southwest Technologies Inc
Dec 28, 2017	HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brand...	Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for us...	Class II	Southwest Technologies Inc
Dec 28, 2017	NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile	Potential for stylet to protrude from the distal end of the catheter	Class II	Epimed International
Dec 28, 2017	PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Pac...	Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub...	Class II	Bard Access Systems Inc.
Dec 28, 2017	2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant ace...	Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is i...	Class II	IMPLANTCAST GMBH
Dec 28, 2017	HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (...	Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for us...	Class II	Southwest Technologies Inc
Dec 27, 2017	Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 2...	Communication-connection error.	Class II	Mako Surgical Corporation
Dec 27, 2017	Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers ...	Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).	Class II	Ormco/Sybronendo
Dec 27, 2017	EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code ...	The secondary supplier provided material was within specification but did not meet our design nee...	Class II	LITTLE RAPIDS CORPORATION
Dec 22, 2017	Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbe...	Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro...	Class II	Arrow International Inc
Dec 22, 2017	Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB	Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro...	Class II	Arrow International Inc
Dec 22, 2017	AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK...	Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro...	Class II	Arrow International Inc
Dec 22, 2017	(1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Po...	Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro...	Class II	Arrow International Inc
Dec 22, 2017	Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Numbe...	Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro...	Class II	Arrow International Inc
Dec 22, 2017	(1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arteria...	Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro...	Class II	Arrow International Inc
Dec 22, 2017	(1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheter...	Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro...	Class II	Arrow International Inc
Dec 22, 2017	LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXP...	Reports of product loosening or coming unscrewed from the handle.	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Dec 22, 2017	Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only	Medtronic has discovered the product lot in question was noted as having a longer drill tip exten...	Class II	Medtronic Sofamor Danek USA Inc
Dec 22, 2017	ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-2430...	Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro...	Class II	Arrow International Inc
Dec 22, 2017	Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part ...	Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro...	Class II	Arrow International Inc
Dec 22, 2017	Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination...	Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to th...	Class II	Roche Diagnostics Corporation
Dec 22, 2017	(1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use wi...	Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro...	Class II	Arrow International Inc
Dec 22, 2017	ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume I...	Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro...	Class II	Arrow International Inc
Dec 22, 2017	(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2...	Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro...	Class II	Arrow International Inc
Dec 22, 2017	AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-428...	Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro...	Class II	Arrow International Inc
Dec 22, 2017	(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) ...	Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro...	Class II	Arrow International Inc
Dec 21, 2017	ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage:...	Certain lots may be missing information at the bottom of the lid including the lot number, expira...	Class II	Arrow International Inc
Dec 21, 2017	Custom Made Implant System with Minimum Invasive Grower (MIG) component	From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to cl...	Class II	Howmedica Osteonics Corp.
Dec 21, 2017	Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetri...	The kits contained an incorrect lot of Dropper Plus Level 1 vials	Class III	Quantimetrix Corporation
Dec 21, 2017	3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per bo...	Inadvertent shipment of expired units.	Class II	Stryker Corporation
Dec 21, 2017	MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 8...	Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was...	Class II	Baxter Healthcare Corporation
Dec 21, 2017	Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control ...	During continuous postmarket surveillance activities, we have noticed a potential malfunction of ...	Class II	W & H DentalWerk Burmoos GMBH - Site 1
Dec 21, 2017	(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100,...	The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system ...	Class II	DePuy Orthopaedics, Inc.
Dec 20, 2017	ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST ...	Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af...	Class II	Zimmer Biomet, Inc.
Dec 20, 2017	ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM ST...	Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af...	Class II	Zimmer Biomet, Inc.
Dec 20, 2017	Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, ...	Medtronic is initiating a voluntary recall because the products identified above did not adequate...	Class II	Medtronic Neurosurgery
Dec 20, 2017	Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (01006083370...	The controls and calibrators contained within the cocaine test kit may cause false positive resul...	Class III	OraSure Technologies, Inc.
Dec 20, 2017	ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 13...	Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af...	Class II	Zimmer Biomet, Inc.
Dec 20, 2017	Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: ...	Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), mi...	Class II	Philips Electronics North America Corporation
Dec 20, 2017	SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600	Certain lots of devices may have the working channel sleeve protruding from the camera cap which ...	Class II	Boston Scientific Corporation
Dec 20, 2017	ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER ...	Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af...	Class II	Zimmer Biomet, Inc.
Dec 20, 2017	The humeral stems trials are packaged in a kit for Titan Modular Shoulder Sys...	Incidents of stem trial breakage were reported to the firm suggesting that these fractures all oc...	Class II	Integra LifeSciences Corp.
Dec 20, 2017	ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM ...	Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af...	Class II	Zimmer Biomet, Inc.
Dec 20, 2017	Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: ...	Mix-up between adult and pediatrics PD catheter.	Class II	Merit Medical Systems, Inc.
Dec 20, 2017	ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST ...	Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af...	Class II	Zimmer Biomet, 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.