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
Apr 18, 2019	Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350	Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock...	Class II	Maquet Cardiovascular, LLC
Apr 18, 2019	Maquet Getinge- BEQ-TOP 32200 ECC Pack Material: 701053319R01	Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock...	Class II	Maquet Cardiovascular, LLC
Apr 18, 2019	Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295	Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock...	Class II	Maquet Cardiovascular, LLC
Apr 18, 2019	Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Ma...	Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock...	Class II	Maquet Cardiovascular, LLC
Apr 18, 2019	Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577	Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock...	Class II	Maquet Cardiovascular, LLC
Apr 18, 2019	Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168	Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock...	Class II	Maquet Cardiovascular, LLC
Apr 18, 2019	Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 70105...	Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock...	Class II	Maquet Cardiovascular, LLC
Apr 18, 2019	Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867	Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock...	Class II	Maquet Cardiovascular, LLC
Apr 18, 2019	Maquet Getinge-BEQ-TOP 22701 Material: 701050790	Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock...	Class II	Maquet Cardiovascular, LLC
Apr 18, 2019	Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01	Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock...	Class II	Maquet Cardiovascular, LLC
Apr 18, 2019	Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060	Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock...	Class II	Maquet Cardiovascular, LLC
Apr 18, 2019	Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01	Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock...	Class II	Maquet Cardiovascular, LLC
Apr 9, 2019	Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assaye...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assaye...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 3, 2019	Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 4...	An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) Ig...	Class II	Bio-Rad Labs
Feb 28, 2019	SmartSite Syringe Administration Set-Product Package Size 50, Catalog Numbe...	Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infu...	Class I	Becton Dickinson & Company
Feb 22, 2019	xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitativ...	Reports have been received of lower MS2 MFI values when using the panel.	Class II	Luminex Molecular Diagnostics
Feb 19, 2019	Foot Switches used with the following systems: 722001 Allura Xper FD 10 C ...	Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitc...	Class II	Philips Medical Systems Nederlands
Feb 1, 2019	NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, ...	Potentially comingled, resulting in the product in the box potentially not matching the product o...	Class II	Zimmer Trabecular Metal Technology, Inc.
Feb 1, 2019	NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, ...	Potentially comingled, resulting in the product in the box potentially not matching the product o...	Class II	Zimmer Trabecular Metal Technology, Inc.
Jan 28, 2019	Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: ...	The product may not have met sterility requirements . Use of a non-sterile device on a patient m...	Class II	Applied Medical Resources Corp
Jan 14, 2019	BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX S...	False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically...	Class II	Becton Dickinson & Co.
Jan 9, 2019	Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Lab...	An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.	Class II	ConvaTec, Inc
Dec 26, 2018	Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) G...	On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplifica...	Class III	Luminex Corporation
Dec 21, 2018	SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resona...	There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ...	Class II	Philips Medical Systems Nederlands
Dec 21, 2018	Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper A...	The product was potentially being packaged without a taper adapter.	Class II	Zimmer Biomet, Inc.
Dec 21, 2018	SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic...	There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ...	Class II	Philips Medical Systems Nederlands
Dec 12, 2018	GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with...	Unintentional shifting of the tip insulation of the firm's electrosurgical probes.	Class II	Applied Medical Resources Corp
Nov 27, 2018	ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp...	Reports of pressure tubing separation between the sampling port and the high pressure tubing on c...	Class II	ICU Medical, Inc.
Nov 27, 2018	ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp...	Reports of pressure tubing separation between the sampling port and the high pressure tubing on c...	Class II	ICU Medical, Inc.
Nov 27, 2018	ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp...	Reports of pressure tubing separation between the sampling port and the high pressure tubing on c...	Class II	ICU Medical, Inc.
Nov 19, 2018	Medex High Pressure Stopcock used to control the direction of IV fluid flow. ...	Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that m...	Class II	Smiths Medical ASD Inc.
Oct 17, 2018	Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should ...	There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally rel...	Class II	Richard Wolf GmbH
Oct 16, 2018	MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PUL...	Devices were distributed despite the Helium-fine leak test results not being within the cochlear ...	Class II	MED-EL Elektromedizinische Gereate, Gmbh
Oct 16, 2018	MED EL Cochlear Implant System, SONATATIi100, sold under the following implan...	Devices were distributed despite the Helium-fine leak test results not being within the cochlear ...	Class II	MED-EL Elektromedizinische Gereate, Gmbh
Oct 16, 2018	MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the follo...	Devices were distributed despite the Helium-fine leak test results not being within the cochlear ...	Class II	MED-EL Elektromedizinische Gereate, Gmbh
Oct 10, 2018	L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic f...	Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of...	Class II	Baxter Healthcare Corporation
Oct 9, 2018	BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2...	This recall has been initiated due to a software defect found in the Guide System software when u...	Class I	Synaptive Medical Inc
Oct 5, 2018	GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066...	The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. ...	Class I	GE Healthcare, LLC
Sep 21, 2018	BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos...	The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. ...	Class III	Becton Dickinson & Co.
Sep 14, 2018	VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pac...	Potential to lead to a false negative results.	Class II	Luminex Corporation
Sep 7, 2018	Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administr...	Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer...	Class II	Bayer Medical Care, Inc.
Aug 1, 2018	Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - ...	There is a potential for increased imprecision, out of range quality controls and prolonged sampl...	Class II	Instrumentation Laboratory Co.
Jul 30, 2018	Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 P...	The item is labeled as an 8.3mm, but it is actually a 12 mm.	Class II	Zimmer Biomet, Inc.
Jul 3, 2018	AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient ...	Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the ...	Class II	ConvaTec, Inc
Jul 2, 2018	Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the foll...	From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried o...	Class II	Radiometer America Inc
Jun 19, 2018	NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath ...	Mislabeled hook pouch included a transport/storage label rather than the product label containin...	Class II	Nico Corp.
May 25, 2018	Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (...	This voluntary recall is being conducted due to the curved tip introducer needle which is include...	Class II	Medtronic Neuromodulation
May 25, 2018	Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a...	This voluntary recall is being conducted due to the curved tip introducer needle which is include...	Class II	Medtronic Neuromodulation
May 22, 2018	Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat....	The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ...	Class II	Randox Laboratories Ltd.

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.