Browse Device Recalls

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

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Date	Product	Reason	Class	Firm
Nov 25, 2015	Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 ...	Pouches may not have been sealed during packing.	Class II	Biomet 3i, LLC
Nov 24, 2015	Persona EM Proximal Tube, orthopedic manual surgical instrument for use with ...	Complaints that the ratchet teeth of the tube are not latching onto the rod.	Class II	Zimmer, Inc.
Nov 24, 2015	Persona EM Distal Rod, orthopedic manual surgical instrument for use with Per...	Complaints that the ratchet teeth of the tube are not latching onto the rod.	Class II	Zimmer, Inc.
Nov 24, 2015	MOSAIQ Oncology Information System. Used to manage workflows for treatment...	First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies dr...	Class II	Elekta, Inc.
Nov 24, 2015	Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use wit...	The sterile blade will not fit into the handle provided with the ETTD system.	Class II	Instratek, Incorporated
Nov 23, 2015	The ZYTO Tower is the input device to program the software with various virtu...	ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite S...	Class II	ZYTO Technologies, Inc.
Nov 23, 2015	VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)	Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation b...	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 23, 2015	0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41...	This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 m...	Class II	Intuitive Surgical, Inc.
Nov 23, 2015	Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshiel...	Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion S...	Class II	Terumo Medical Corp
Nov 23, 2015	The ZYTO Select and ZYTO Elite software programs are used to rank pairs of ga...	ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite S...	Class II	ZYTO Technologies, Inc.
Nov 23, 2015	Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units ...	The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date o...	Class II	Stryker Instruments Div. of Stryker Corporation
Nov 23, 2015	30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-4...	This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 m...	Class II	Intuitive Surgical, Inc.
Nov 23, 2015	Granada Biphasic Broth The product is a selective medium for the screening...	FDA has determined that the product requires 510(k) clearance to continue marketing/distribution ...	Class II	Biomerieux Inc
Nov 20, 2015	FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 ...	Product is incorrectly labeled. The blade configuration in the affected lots does not match the d...	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
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	Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with EN...	Potential for leaking between the purple ENFit connector and the white transitional stepped conne...	Class II	MOOG Medical Devices Group
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	A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization ...	These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in th...	Class II	Biomet, Inc.
Nov 20, 2015	Cardinal Health Tiny Toes; 11470-010T Infant heel warmer	Heel warmers may cause first and second degree burns.	Class II	Philips Electronics North America Corporation
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	WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of stea...	"The public reason for the recall is that the product is being recalled out of an abundance of ca...	Class II	Bigwall Enterprises
Nov 20, 2015	FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Inte...	Product is incorrectly labeled. The blade configuration in the affected lots does not match the d...	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 20, 2015	AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the ...	The firm discovered that information printed on the quick reference magnet is incorrect; specific...	Class II	Steris Corporation
Nov 20, 2015	FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 In...	Product is incorrectly labeled. The blade configuration in the affected lots does not match the d...	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
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
Nov 20, 2015	Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument ...	Manufacturing error within the Torque Handle may prohibit some handles from being able to fully a...	Class II	DePuy Spine, Inc.
Nov 19, 2015	Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW ...	Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically fa...	Class I	Biomerieux
Nov 19, 2015	Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene o...	Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientifi...	Class I	Boston Scientific Corporation
Nov 19, 2015	Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantita...	Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically fa...	Class I	Biomerieux
Nov 19, 2015	Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Num...	Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves wh...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 19, 2015	VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access an...	Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricul...	Class II	Cook Inc.
Nov 19, 2015	Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitati...	Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically fa...	Class I	Biomerieux
Nov 19, 2015	Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantita...	Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically fa...	Class I	Biomerieux
Nov 19, 2015	MOVES System Lithium Polymer Batteries The MOVES System is a portable comp...	Batteries found unresponsive after storage, not recognized by main device, and are perpetually en...	Class I	Thornhill Research Inc
Nov 19, 2015	MOVES System, an emergency ventilator with suction, oxygen concentrator and m...	Batteries found unresponsive after storage, not recognized by main device, and are perpetually en...	Class I	Thornhill Research Inc
Nov 18, 2015	Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106	Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartb...	Class II	Cyberonics, Inc
Nov 18, 2015	Software version VD10E for Syngo X-Workplace; Picture archiving and communica...	Potential post-processing software issue when using tabcard "4D" on X-Workplace with software ver...	Class II	Siemens Medical Solutions USA, Inc
Nov 18, 2015	Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingred...	Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because ...	Class II	Rainbow Specialty & Health Products
Nov 18, 2015	FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A f...	The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fung...	Class II	Hardy Diagnostics
Nov 18, 2015	IBS - Osteosynthesis screws for bone fixation Model S25 ST014.	One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw...	Class II	In2Bones, SAS
Nov 18, 2015	Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingred...	Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because ...	Class II	Rainbow Specialty & Health Products
Nov 18, 2015	TCM CombiM Modules 903-111	Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that ca...	Class II	Radiometer America Inc
Nov 18, 2015	MEVION S250 Radiation therapy system	The treatment table positioning belt can slip gear positions, resulting in deviation of patient s...	Class II	Mevion Medical Systems, Inc.
Nov 17, 2015	Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retra...	AAG received a customer complaint that corrosion had been found by a hospitals central sterile s...	Class II	Aesculap, Inc.
Nov 17, 2015	MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirt...	MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor wer...	Class II	Owens & Minor Distribution, Inc.
Nov 17, 2015	Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a post...	Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through prod...	Class II	Zimmer Biomet, Inc.
Nov 17, 2015	MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirt...	MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor wer...	Class II	Owens & Minor Distribution, Inc.
Nov 17, 2015	Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne ...	Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Pie...	Class II	Lumenis Ltd
Nov 17, 2015	BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Us...	Some tubes were manufactured with the stopper not fully inserted into the tube. This may result i...	Class II	Becton Dickinson & Company
Nov 17, 2015	The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pne...	Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Se...	Class I	Stryker Sustainability Solutions

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.