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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

2,939 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,939 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 2,939 FDA device recalls in PA.

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DateProductReasonClassFirm
Sep 21, 2020 END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 18, 2020 ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intende... There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Ph... Class II Siemens Medical Solutions USA, Inc
Sep 9, 2020 Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector... After the March 2019 corrective action on the monitor support arm, there is a residual risk of th... Class II Siemens Medical Solutions USA, Inc
Sep 9, 2020 Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector flu... After the March 2019 corrective action on the monitor support arm, there is a residual risk of th... Class II Siemens Medical Solutions USA, Inc
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, ... Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... Class II Aesculap Implant Systems LLC
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, p... Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... Class II Aesculap Implant Systems LLC
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE ... Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... Class II Aesculap Implant Systems LLC
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE ... Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... Class II Aesculap Implant Systems LLC
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE ... Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... Class II Aesculap Implant Systems LLC
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, ... Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... Class II Aesculap Implant Systems LLC
Aug 31, 2020 Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to b... The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associate... Class II Olympus Corporation of the Americas
Aug 31, 2020 Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Ol... The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the d... Class II Olympus Corporation of the Americas
Aug 19, 2020 Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_... Calibration offset between the central CT image plane and the external RT lasers has been set aut... Class II Siemens Medical Solutions USA, Inc
Aug 3, 2020 Artis zee or Artis Q systems (listed below) - Product Usage: for single and b... Potential exists for the collision supervision not to work properly following loss of the individ... Class II Siemens Medical Solutions USA, Inc
Jul 30, 2020 Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and... Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after... Class II Siemens Medical Solutions USA, Inc
Jul 30, 2020 Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and ... Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after... Class II Siemens Medical Solutions USA, Inc
Jul 27, 2020 Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024 Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F inst... Class II Medical Components, Inc dba MedComp
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 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 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 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 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 15, 2020 CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: ind... Unit boxes not properly sealed Class III OraSure Technologies, Inc.
Jul 15, 2020 Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product... Unit boxes not properly sealed Class III OraSure Technologies, Inc.
Jul 15, 2020 Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 100... Unit boxes not properly sealed Class III OraSure Technologies, Inc.
Jul 14, 2020 Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement ... Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143... Class II Olympus Corporation of the Americas
Jul 14, 2020 Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cio... Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D... Class II Siemens Medical Solutions USA, Inc
Jul 14, 2020 Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement... Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143... Class II Olympus Corporation of the Americas
Jul 13, 2020 ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle... Class II Aesculap Implant Systems LLC
Jul 13, 2020 Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate ... Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included ... Class III OraSure Technologies, 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.