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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

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

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DateProductReasonClassFirm
Mar 16, 2021 REF Spinning Spiros Closed Male Luer - Product Usage: provides access for th... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, A... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides acce... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: prov... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filt... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" -... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLoc... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Ve... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Sp... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Dri... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PO... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. F... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLo... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave D... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port L... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/Che... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClav... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Ve... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 10, 2021 Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus ... When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than n... Class II Remel Inc
Mar 10, 2021 Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus... When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than n... Class II Remel Inc
Mar 8, 2021 BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Produc... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 -... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Prod... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 -... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Produc... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Pr... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Prod... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Produ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Produ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usag... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usa... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usa... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Produ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usag... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usa... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Pr... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm... Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the b... Class II Arrow International Inc
Mar 8, 2021 BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Pro... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK 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.