Browse Device Recalls

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

Date	Product	Reason	Class	Firm
Dec 16, 2021	Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300	26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxyg...	Class II	Draeger Medical, Inc.
Dec 16, 2021	Digital Angiography System Bransist safire Generator Model D150GC-40	Due to the inadequate adjusting criteria in installation, the system generator on two Digital Ang...	Class II	Shimadzu Medical Systems
Dec 15, 2021	Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, ...	As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) bei...	Class II	Medtronic Xomed, Inc.
Dec 15, 2021	CURAD REUSABLE GEL HOT/COLD PACK	The product contains natural rubber latex but the label states that it does not.	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 15, 2021	20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box	Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b...	Class III	CellEra LLC
Dec 15, 2021	20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box	Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b...	Class III	CellEra LLC
Dec 15, 2021	20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box	Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b...	Class III	CellEra LLC
Dec 15, 2021	20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box	Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b...	Class III	CellEra LLC
Dec 15, 2021	20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box	Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b...	Class III	CellEra LLC
Dec 14, 2021	OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. ...	The firm has received complaints of the OXY-1 System Console experiencing a power interruption wh...	Class I	Abiomed, Inc.
Dec 14, 2021	Acufex Access Advanced Positioning Kit - indicated for use to position and di...	Products were shipped to the Global Distribution Center instead of the sterilizer and therefore p...	Class II	Smith & Nephew, Inc.
Dec 13, 2021	RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for ...	Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk o...	Class II	Collagen Matrix, Inc.
Dec 13, 2021	OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfecti...	The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If th...	Class II	Olympus Corporation of the Americas
Dec 13, 2021	DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0...	Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk o...	Class II	Collagen Matrix, Inc.
Dec 13, 2021	The EnPlace is a single use trans-vaginal pelvic floor repair system which en...	Certain lots may not have been packaged wth the Channel Tube Limiter.	Class II	FEMSelect Ltd
Dec 10, 2021	THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA	This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. Th...	Class II	Mallinckrodt Pharmaceuticals Ireland Ltd
Dec 10, 2021	VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales ...	The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or re...	Class II	Ortho-Clinical Diagnostics, Inc.
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the fo...	A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) h...	Class I	Getinge Usa Sales Inc
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 9, 2021	greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-...	Some of the blood collection tubes show clotting due to variation of Lithium Heparin.	Class II	Greiner Bio-One North America, Inc.
Dec 9, 2021	ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray p...	Potential safety issue under specific preconditons that may result in a user selecting the wrong ...	Class II	Siemens Medical Solutions USA, Inc
Dec 9, 2021	The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E...	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o...	Class II	DIXI MEDICAL USA
Dec 8, 2021	AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850	Lipemic interference for the Magnesium serum application failed to meet the performance claim as ...	Class II	Beckman Coulter Inc.
Dec 8, 2021	R82 by ETAC Push Brace for High-Low	The chrome surface of the push brace can crack during use, potentially cutting the user.	Class II	R82 A/S
Dec 8, 2021	Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model ...	There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needl...	Class II	Technomed Europe
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- ...	Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the N...	Class II	Fresenius Medical Care Holdings, Inc.
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 6, 2021	Alinity m System, Part No. 08N53-002	There is an issue with the installation of updated camera firmware on the system.	Class II	Abbott Molecular, Inc.
Dec 6, 2021	Alinity m System, Part No. 08N53-002	There is a software defect that can cause the Amplification Detection clamp CLEAN position to be ...	Class II	Abbott Molecular, Inc.
Dec 6, 2021	Alinity m System, Part No. 08N53-002	There is a software issue associated with the ability to properly complete a Field Service Engine...	Class II	Abbott Molecular, Inc.
Dec 6, 2021	LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number L...	Customers reported that the device jaws were difficult to open or would not open following applic...	Class II	Covidien Llc
Dec 6, 2021	Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1...	Reports have been received of tip damage during use of the devices which resulted in some instanc...	Class I	ev3 Inc.
Dec 6, 2021	Alinity m System, Part No. 08N53-002	There is a potential for abnormal (non-sigmoidal) amplification curves.	Class II	Abbott Molecular, Inc.
Dec 6, 2021	Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1...	Reports have been received of tip damage during use of the devices which resulted in some instanc...	Class I	ev3 Inc.
Dec 3, 2021	Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.	The incorrect product is contained in the packaging.	Class II	Wright Medical Technology Inc
Dec 3, 2021	ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing a...	lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incor...	Class II	Konica Minolta Healthcare Americas, 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.