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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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.

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DateProductReasonClassFirm
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 Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm ... The firm has identified a potential for the backrest to become detached from the chair. Class II Accora Inc
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 Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. T... It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 a... Class I Respironics California, LLC
Jun 18, 2021 Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10.... It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 a... Class I Respironics California, LLC
Jun 18, 2021 ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the... Out of Specification Class II Remel Inc
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 Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. ... There is a potential risk of device contamination and patient infection associated with the devic... Class II Gentherm Medical, LLC
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 16, 2021 Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 7... The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalp... Class I Cardinal Health 200, LLC
Jun 15, 2021 EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites throu... There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration dat... Class II Baxter Healthcare Corporation
Jun 14, 2021 DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Ser... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Conti... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, R... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Venti... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Suppo... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 Revolution EVO, Optima CT660, Optima CT680 CT Systems. Improperly loaded software options may result in additional X -ray radiation exposure to the pati... Class II GE Healthcare, LLC
Jun 14, 2021 Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience k... Instructions for use updated to include the following cautionary statement for the heel warmer, "... Class II ROi CPS LLC
Jun 14, 2021 Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF... Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to t... Class II Arthrex, Inc.
Jun 14, 2021 Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience k... Instructions for use updated to include the following cautionary statement for the heel warmer, "... Class II ROi CPS LLC
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 14, 2021 Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators. The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience k... Instructions for use updated to include the following cautionary statement for the heel warmer, "... Class II ROi CPS LLC
Jun 11, 2021 CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D... Due to reports of actuator separation for various delivery catheter systems. Affected products w... Class II Medtronic Heart Valves Division
Jun 11, 2021 CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N; Due to reports of actuator separation for various delivery catheter systems. Affected products w... Class II Medtronic Heart Valves Division
Jun 11, 2021 CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16; Due to reports of actuator separation for various delivery catheter systems. Affected products w... Class II Medtronic Heart Valves Division
Jun 10, 2021 REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architec... There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) sample... Class II Abbott Laboratories
Jun 10, 2021 REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architec... There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) sample... Class II Abbott Laboratories
Jun 10, 2021 OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and ... There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplet... Class II GE OEC Medical Systems, Inc
Jun 10, 2021 Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box. No 510(k) clearance Class II Mercedes Medical, Inc.
Jun 10, 2021 Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, contai... No 510(k) clearance Class II Mercedes Medical, Inc.
Jun 10, 2021 basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate... Due to a design issue, inflation syringe handle separating from the inflation device when handle ... Class II Merit Medical Systems, Inc.
Jun 10, 2021 OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product... There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplet... Class II GE OEC Medical Systems, Inc
Jun 10, 2021 REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Ki... There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples... Class II Abbott Laboratories
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 10, 2021 REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architec... There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) sample... Class II Abbott Laboratories
Jun 9, 2021 MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product ... A portion of a validation lot was inadvertently released to the US Market. The product did not m... Class II CAREFUSION
Jun 9, 2021 Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, me... Expired adhesive used as an electrical insulation barrier and as a secondary retention bond faile... Class II Olympus Corporation of the Americas
Jun 9, 2021 Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU M... A caution statement is being added to remind the user to activate away from face and infant as r... Class II Cardinal Health 200, LLC
Jun 9, 2021 Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH000... A caution statement is being added to remind the user to activate away from face and infant as r... Class II Cardinal Health 200, LLC
Jun 9, 2021 Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in ... The product in the packaging is larger (both inner and outer diameter) than the labeling indicates. Class II Cordis Corporation
Jun 8, 2021 Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-r... When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... Class II Philips North America Llc
Jun 8, 2021 Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #... intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calib... Class II Terumo Cardiovascular Systems Corporation
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 8, 2021 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iC... When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... Class II Philips North America Llc
Jun 8, 2021 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... Class II Philips North America Llc
Jun 8, 2021 728332 IQon Spectral CT-Computed Tomography X-ray system When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... Class II Philips North America Llc
Jun 8, 2021 728333 Spectral CT 7500 -Computed Tomography X-ray system When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... Class II Philips North America Llc

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.