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
Jun 28, 2021	MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001	There is an incorrect version of the needle in the introducer part of devices. The affected Lots ...	Class II	MY01, INC.
Jun 25, 2021	CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323	Product labeled as Cutting Electrode may contain BIVAP electrode.	Class II	Richard Wolf GmbH
Jun 25, 2021	The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS...	Potential patient exposure to the graphite substrate.	Class II	Tornier S.A.S.
Jun 22, 2021	MYLA software. Used to manage microbiology test workflow from the reception ...	Software anomaly - Under certain conditions, unwanted alterations to results could be applied whe...	Class II	BioMerieux SA
Jun 21, 2021	DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b...	Problems related to the sterilization of the medical devices; possible missing sterility of the m...	Class II	Delta Med SpA
Jun 21, 2021	NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122	Problems related to the sterilization of the medical devices; possible missing sterility of the m...	Class II	Delta Med SpA
Jun 21, 2021	DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3...	Problems related to the sterilization of the medical devices; possible missing sterility of the m...	Class II	Delta Med SpA
Jun 21, 2021	DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) ...	Problems related to the sterilization of the medical devices; possible missing sterility of the m...	Class II	Delta Med SpA
Jun 21, 2021	WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c)...	Problems related to the sterilization of the medical devices; possible missing sterility of the m...	Class II	Delta Med SpA
Jun 21, 2021	NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822	Problems related to the sterilization of the medical devices; possible missing sterility of the m...	Class II	Delta Med SpA
Jun 21, 2021	DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 383257...	Problems related to the sterilization of the medical devices; possible missing sterility of the m...	Class II	Delta Med SpA
Jun 21, 2021	NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 ...	Problems related to the sterilization of the medical devices; possible missing sterility of the m...	Class II	Delta Med SpA
Jun 21, 2021	NEO DELTA SELFSAFE PUR T, I.V. Catheter:	Problems related to the sterilization of the medical devices; possible missing sterility of the m...	Class II	Delta Med SpA
Jun 21, 2021	NEO DELTA Self Safe, I.V. Catheter REF 3738222	Problems related to the sterilization of the medical devices; possible missing sterility of the m...	Class II	Delta Med SpA
Jun 21, 2021	NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5...	Problems related to the sterilization of the medical devices; possible missing sterility of the m...	Class II	Delta Med SpA
Jun 18, 2021	Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000	When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system con...	Class II	WOM World of Medicine AG
Jun 17, 2021	Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(...	Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire T...	Class II	Medicalplastic S.R.L.
Jun 14, 2021	Proteus 235- designed to produce and deliver a proton beam for the treatment ...	Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology...	Class II	Ion Beam Applications S.A.
Jun 10, 2021	Arjo Citadel beds originally assembled with the IndiGo modules during manufct...	The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord...	Class II	ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Jun 8, 2021	RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1...	Initial delivery positions will be set incorrectly when having setup beam(s) at the localization ...	Class II	RAYSEARCH LABORATORIES AB
Jun 4, 2021	Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08...	The patient may be exposed to potential aluminum ion release during warming therapy under certain...	Class I	Eight Medical International BV
Jun 4, 2021	Simpleware ScanIP medical software. For transfer of imaging information from...	A issue (bug) has been identified with the interface and image software which could result in an...	Class II	Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Jun 4, 2021	Simpleware ScanIP software. For transfer of imaging information from a medica...	A issue (bug) has been identified with the interface and image software which could result in an...	Class II	Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
May 27, 2021	Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte sp...	May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe fai...	Class II	Cytocell Ltd.
May 26, 2021	Azurion systems with software release R1.x	In the Azurion system, the user can add a new study to a patient by selecting the option Add St...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
May 26, 2021	Proteus 235-Proton Therapy System	if the user forgets to select the trigger input manually while beam gating is prescribed for the...	Class II	Ion Beam Applications S.A.
May 25, 2021	OxyMask O2 Adult REF OM-1125-14	Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in ...	Class II	Southmedic, Inc.
May 25, 2021	Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. ...	The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can...	Class II	Remote Diagnostic Technologies Ltd.
May 17, 2021	Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Num...	The recalling firm was notified by the contract sterilizer that the process parameters of the ste...	Class II	ADRIA SRL
May 17, 2021	AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monit...	In some cases the equipment fails to power up and/or key or button unresponsive or not working.	Class II	Mediana Co., Ltd.
May 17, 2021	CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number L...	The device may show unexpected locus specific signals in addition to those at 22q. Users may obse...	Class II	Cytocell Ltd.
May 17, 2021	Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749	The recalling firm was notified by the contract sterilizer that the process parameters of the ste...	Class II	ADRIA SRL
May 17, 2021	Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745	The recalling firm was notified by the contract sterilizer that the process parameters of the ste...	Class II	ADRIA SRL
May 14, 2021	ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Ins...	Display of potential patient movement might be delayed to the user for high dose treatments.	Class II	Brainlab AG
May 10, 2021	NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA ...	Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect va...	Class II	Randox Laboratories Ltd.
May 5, 2021	Omnera 400T Digital Radiographic System	There is the potential for the X-Ray system to short circuit due to an ingress of liquid in th...	Class II	Arcoma AB
May 5, 2021	Omnera 400A Digital Radiographic System	There is the potential for the X-Ray system to short circuit due to an ingress of liquid in th...	Class II	Arcoma AB
Apr 27, 2021	Quanta System Sterile Optical Laser Fiber, single use	Product sterility is potentially compromised.	Class II	Quanta System, S.p.A.
Apr 27, 2021	Olympus Sterile Optical Laser Fiber, single use and reusable	Product sterility is potentially compromised.	Class II	Quanta System, S.p.A.
Apr 27, 2021	Quanta System Sterile Optical Laser Fiber, reusable	Product sterility is potentially compromised.	Class II	Quanta System, S.p.A.
Apr 26, 2021	Concerto User Interface Software provided with the following systems: (1) ...	If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not u...	Class II	Xstrahl Limited
Apr 23, 2021	Synaptive Trackable Suction Set Standard and Malleable	Due to visible burrs/metal filings affixed along the suction tube inner perimeter.	Class II	Synaptive Medical Inc
Apr 21, 2021	Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f...	Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel...	Class II	INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021	Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f...	Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel...	Class II	INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021	Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the fo...	Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel...	Class II	INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021	Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination b...	Removing parts for safety reasons due to possible breakage.	Class II	Dentech Corp.
Apr 21, 2021	RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 ...	Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after ...	Class II	RAYSEARCH LABORATORIES AB
Apr 12, 2021	DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 0...	failed rivet at the chafe tab of arm sling.	Class II	DJ Orthopedics de Mexico S.A. de C.V.
Apr 12, 2021	DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)001904466735...	failed rivet at the chafe tab of arm sling.	Class II	DJ Orthopedics de Mexico S.A. de C.V.
Apr 12, 2021	DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446...	failed rivet at the chafe tab of arm sling.	Class II	DJ Orthopedics de Mexico S.A. de C.V.

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.