Browse Device Recalls

2,049 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,049 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 2,049 FDA device recalls in N/A.

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Date	Product	Reason	Class	Firm
Sep 25, 2020	Osteosynthesis Compression Staple EasyClip	The device has the potential to release nickel above the acceptable margin of safety in pediatric...	Class II	Stryker GmbH
Sep 22, 2020	ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038...	When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated se...	Class I	Flexicare Medical Ltd.
Sep 22, 2020	TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, ...	Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).	Class II	Gordian Surgical
Sep 11, 2020	Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Produc...	The magnet located inside the foot pedal may come off and may result in unattended start of unsto...	Class II	Bien-Air Surgery Sa
Sep 11, 2020	Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Us...	The magnet located inside the foot pedal may come off and may result in unattended start of unsto...	Class II	Bien-Air Surgery Sa
Sep 11, 2020	Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: i...	The magnet located inside the foot pedal may come off and may result in unattended start of unsto...	Class II	Bien-Air Surgery Sa
Sep 11, 2020	Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product U...	The magnet located inside the foot pedal may come off and may result in unattended start of unsto...	Class II	Bien-Air Surgery Sa
Sep 11, 2020	Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Pr...	The magnet located inside the foot pedal may come off and may result in unattended start of unsto...	Class II	Bien-Air Surgery Sa
Sep 10, 2020	Instructions For Use document of the GPS Trackers.	Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some...	Class II	Blue Ortho
Sep 8, 2020	AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM...	The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result ...	Class II	ESAOTE S.P.A
Sep 8, 2020	AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM...	The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result ...	Class II	ESAOTE S.P.A
Sep 4, 2020	1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage:...	Firm has received 6 complaints that the Heat Moisture Exchanger (HME) disconnected from the close...	Class II	AB ULAX
Sep 2, 2020	GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: ...	The firm has identified lots of calibrators that have shown to measure incorrect high values over...	Class II	Gentian AS
Aug 31, 2020	Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cr...	Brainlab Ultrasound Navigation Software does not support the modification of the probe's image wi...	Class II	Brainlab AG
Aug 25, 2020	Change Healthcare Radiology Solutions 14.0	Software defect which may potentially result in one or more images missing in a study	Class II	CHANGE HEALTHCARE CANADA COMPANY
Aug 24, 2020	Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component ...	The firm has received reports concerning the patient fiducial disk separating from the body and u...	Class II	Imactis
Aug 21, 2020	SwiftHook sold as the following: a. Individually as SwiftHook b. Included w...	Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook com...	Class II	Handicare AB
Aug 20, 2020	Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56...	Holding force of the Positioning Arm can be reduced by prolonged non-use.	Class II	Brainlab AG
Aug 11, 2020	Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage...	An update to the carryover avoidance technical bulletin to introduce additional steps for reagent...	Class II	Randox Laboratories Ltd.
Aug 11, 2020	Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: devic...	An update to the carryover avoidance technical bulletin to introduce additional steps for reagent...	Class II	Randox Laboratories Ltd.
Aug 7, 2020	FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-...	Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has ...	Class II	Inpeco S.A.
Aug 7, 2020	Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual r...	Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has ...	Class II	Inpeco S.A.
Aug 7, 2020	Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual r...	Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has ...	Class II	Inpeco S.A.
Aug 6, 2020	Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device ...	Due to the incorrect DC/DC converter being assembled onto the communication board. As a result t...	Class II	Carl Zeiss Meditec AG
Aug 6, 2020	Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnosti...	Due to the incorrect DC/DC converter being assembled onto the communication board. As a result t...	Class II	Carl Zeiss Meditec AG
Jul 30, 2020	AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in v...	Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol...	Class II	RANDOX LABORATORIES, LTD.
Jul 30, 2020	AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in v...	Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol...	Class II	RANDOX LABORATORIES, LTD.
Jul 29, 2020	Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only...	LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce...	Class II	Sorin Group Italia S.r.l.
Jul 29, 2020	Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only...	LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce...	Class II	Sorin Group Italia S.r.l.
Jul 29, 2020	Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, U...	LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce...	Class II	Sorin Group Italia S.r.l.
Jul 29, 2020	RayCare, device is stand-alone software - Product Usage: used to support work...	When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image re...	Class II	RAYSEARCH LABORATORIES AB
Jul 29, 2020	Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only,...	LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce...	Class II	Sorin Group Italia S.r.l.
Jul 29, 2020	Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only,...	LivaNova received complaints indicating the impossibility to collapse Perceval valve during proce...	Class II	Sorin Group Italia S.r.l.
Jul 27, 2020	Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is ...	Sample leaking from the sleeve covering the needle inside the cannula	Class II	C.A. Greiner & Sohne Gesellschaftmbh
Jul 23, 2020	Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Numb...	Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not perfor...	Class II	Remel Europe Ltd.
Jul 22, 2020	CombiDiagnost R90 Software Version R1.0 and R1.1	Philips has become aware of a software issue, where the kV and mA values are not locked immediate...	Class II	Philips Medical Systems Gmbh, DMC
Jul 22, 2020	POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 008855565...	Multiple lots being recalled due to a product design issue	Class II	Smith & Nephew Orthopaedics AG
Jul 21, 2020	Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is ...	Modular Junction Box (MJB) cables can melt and affect the bed functionality.	Class II	ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Jul 20, 2020	NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Us...	Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant me...	Class II	NOBEL BIOCARE SERVICES AG
Jul 17, 2020	Match Point System The Match Point System is intended to by uses as a surg...	The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly i...	Class II	Materialise N.V.
Jul 17, 2020	Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal p...	A low risk of a false positive result being issued with a laboratory developed test (LDT) that ut...	Class II	Cytocell Ltd.
Jul 17, 2020	Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Pl...	IBA became aware of an issue to resume aborted irradiations because the plan to complete the trea...	Class II	Ion Beam Applications S.A.
Jul 16, 2020	uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is inte...	1) Service function problem may cause false marking of a bad channel resulting in ring artifacts;...	Class II	Shanghai United Imaging Healthcare Co., Ltd.
Jul 16, 2020	Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usag...	Incorrect expiration date included in test kit labeling and/or in Substrate component label.	Class III	Oxford Immunotec
Jul 16, 2020	Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usag...	Incorrect expiration date included in test kit labeling and/or in Substrate component label.	Class III	Oxford Immunotec
Jul 16, 2020	uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is in...	1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Poten...	Class II	Shanghai United Imaging Healthcare Co., Ltd.
Jul 16, 2020	BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; ...	Incorrect manufacturer calibration	Class II	Brainlab AG
Jul 16, 2020	BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 U...	Incorrect manufacturer calibration	Class II	Brainlab AG
Jul 10, 2020	Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked...	Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the qu...	Class II	RANDOX LABORATORIES, LTD.
Jul 10, 2020	Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent	Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the qu...	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.