Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

Clear
DateProductReasonClassFirm
Jul 27, 2020 Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z184... Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... Class II Karl Storz Endoscopy
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Ki... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z184... Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... Class II Karl Storz Endoscopy
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 068... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB ... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan)... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 27, 2020 Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual:... Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... Class II Karl Storz Endoscopy
Jul 27, 2020 Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z184... Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... Class II Karl Storz Endoscopy
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N:... Potential Endotoxin Contamination Class II Datascope Corporation
Jul 24, 2020 DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intend... Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user o... Class II Ra Medical Systems, Inc.
Jul 24, 2020 Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barrica... The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner co... Class II Intrinsic Therapeutics, Inc.
Jul 24, 2020 Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 modu... The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connec... Class II Siemens Medical Solutions USA, Inc
Jul 24, 2020 Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD... Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples Class II Siemens Healthcare Diagnostics, Inc.
Jul 24, 2020 NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur... During explantation, standard removal tools can generate sufficient forces to cause distal plug t... Class II Nuvasive Specialized Orthopedics Inc
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 ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile) Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
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 ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
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 22, 2020 ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 21, 2020 Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI:... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKI... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
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 21, 2020 Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI:... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm -... May have one or more dimensional features out of tolerance includes: thread pitch diameter depth,... Class II Synthes (USA) Products LLC
Jul 21, 2020 Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: ... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: ... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: ... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: markete... Disposable face masks labeled as non-medical were distributed to customers expecting medical use ... Class II BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA

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.