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
Jul 8, 2013	PrepStain Tecan US-II. For use in the screening and detection of cervical ...	PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine pr...	Class II	Becton Dickinson & Co.
Jul 8, 2013	PrepStain Tecan US-I. For use in the screening and detection of cervical c...	PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine pr...	Class II	Becton Dickinson & Co.
Jul 5, 2013	pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. ...	RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on...	Class II	Radiometer America Inc
Jul 5, 2013	Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40,...	The patient support may move in an unintended manner if the footswitch cover impinges on the foot...	Class II	Philips Medical Systems (Cleveland) Inc
Jul 3, 2013	Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332...	Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and...	Class II	Medtronic MiniMed
Jul 3, 2013	Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Pai...	Lancets were not sterilized within the dose range established by sterilization validation.	Class II	KooJoo Trading Company
Jul 2, 2013	MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoS...	Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper...	Class II	Ecolab Inc
Jul 2, 2013	MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R),...	Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper...	Class II	Ecolab Inc
Jul 2, 2013	Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, RE...	Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper...	Class II	Ecolab Inc
Jul 2, 2013	MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R...	Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper...	Class II	Ecolab Inc
Jul 2, 2013	MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 1...	Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper...	Class II	Ecolab Inc
Jul 2, 2013	Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedul...	Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.	Class II	Stryker Howmedica Osteonics Corp.
Jul 2, 2013	Monaco RTP System Radiation treatment planning	Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch ...	Class II	Elekta, Inc.
Jul 2, 2013	MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSil...	Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper...	Class II	Ecolab Inc
Jul 1, 2013	MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an opti...	The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate v...	Class I	Iradimed Corporation
Jul 1, 2013	Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performan...	The safety margin values detailed in the Engineering Design were entered incorrectly into the pro...	Class II	Stryker Instruments Div. of Stryker Corporation
Jul 1, 2013	Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (D...	Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimens...	Class II	Siemens Healthcare Diagnostics, Inc.
Jul 1, 2013	CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used wit...	The safety margin values detailed in the Engineering Design were entered incorrectly into the pro...	Class II	Stryker Instruments Div. of Stryker Corporation
Jul 1, 2013	RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and T...	The safety margin values detailed in the Engineering Design were entered incorrectly into the pro...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 28, 2013	REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, ...	There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to frac...	Class II	Zimmer, Inc.
Jun 28, 2013	REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, ...	There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to frac...	Class II	Zimmer, Inc.
Jun 28, 2013	ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04...	Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 A...	Class III	Siemens Healthcare Diagnostics, Inc
Jun 28, 2013	Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated f...	Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer cart...	Class II	Medtronic Neurosurgery
Jun 28, 2013	Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior F...	The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 4...	Class II	Alphatec Spine, Inc.
Jun 27, 2013	MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25-...	The product was registered and distributed as a Class I medical device and was subsequently deter...	Class II	Insight Instruments, Inc.
Jun 26, 2013	ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21...	Siemens issued a customer safety advisory notice and field safety corrective action for a potenti...	Class II	Siemens Medical Solutions USA, Inc
Jun 26, 2013	PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog N...	Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the...	Class II	Siemens Healthcare Diagnostics
Jun 26, 2013	Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 302...	High inlet water pressure beyond specification and the solenoid valve does not meet application w...	Class II	Mar Cor Purification
Jun 26, 2013	ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . ...	The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When th...	Class II	Siemens Healthcare Diagnostics
Jun 25, 2013	ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN...	ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for t...	Class II	Siemens Healthcare Diagnostics, Inc
Jun 25, 2013	ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage:...	ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu...	Class III	Convatec Inc.
Jun 25, 2013	ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage f...	ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu...	Class III	Convatec Inc.
Jun 24, 2013	SC2316, Distal Femoral Augment with Screw Total knee replacement due to os...	The firm became aware of an incident relating to a breach of sterility in the sterility barrier p...	Class II	Stelkast Co
Jun 24, 2013	Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Cat...	The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner...	Class II	Stryker Neurovascular
Jun 24, 2013	Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Pro...	A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet C...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 24, 2013	Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product ...	A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet C...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 24, 2013	Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product...	A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet C...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 22, 2013	Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The M...	A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking ...	Class II	Synthes USA HQ, Inc.
Jun 21, 2013	LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product...	Product contains particulates (fibers)	Class II	Genzyme Corporation, A Sanofi Company
Jun 21, 2013	LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number:...	Product contains particulates (fibers)	Class II	Genzyme Corporation, A Sanofi Company
Jun 21, 2013	LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Produ...	Product contains particulates (fibers)	Class II	Genzyme Corporation, A Sanofi Company
Jun 21, 2013	Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surg...	The outer box label of the product was labeled with a down revision label which did not include t...	Class II	Myoscience Inc
Jun 21, 2013	MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or e...	Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue asso...	Class II	MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA...
Jun 21, 2013	LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a w...	Product contains particulates (fibers)	Class II	Genzyme Corporation, A Sanofi Company
Jun 21, 2013	LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Produc...	Product contains particulates (fibers)	Class II	Genzyme Corporation, A Sanofi Company
Jun 21, 2013	LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Produc...	Product contains particulates (fibers)	Class II	Genzyme Corporation, A Sanofi Company
Jun 21, 2013	LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a wa...	Product contains particulates (fibers)	Class II	Genzyme Corporation, A Sanofi Company
Jun 21, 2013	LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is...	Product contains particulates (fibers)	Class II	Genzyme Corporation, A Sanofi Company
Jun 21, 2013	Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized f...	Difficulty removing screws from the Invue caddies.	Class II	SpineFrontier, Inc.
Jun 21, 2013	LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is...	Product contains particulates (fibers)	Class II	Genzyme Corporation, A Sanofi Company

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.