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Vehicle Safety

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

2,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,969 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 2,969 FDA device recalls in PA.

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DateProductReasonClassFirm
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.
Jul 13, 2020 Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate... Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included ... Class III OraSure Technologies, Inc.
Jul 8, 2020 Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usa... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product U... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usa... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Us... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Us... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Us... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 6, 2020 Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Cathete... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Ne... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in t... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to prov... Suspect poor weld on back KD bar. Class II Golden Technologies, Inc.
Jun 24, 2020 syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation ... Class II Siemens Medical Solutions USA, Inc
Jun 22, 2020 Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATO... Sporadic problems with the current software may result in scanning workflow interruptions and une... Class II Siemens Medical Solutions USA, Inc
Jun 18, 2020 MatrixNEURO Screws - Product Usage: The intended use for this device is in fi... One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm s... Class II Synthes, Inc.
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0... A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International Inc
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code ... A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International Inc
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP... A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International Inc
May 20, 2020 Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product... A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International Inc
May 20, 2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code ... A potential issue with a component within the above-referenced IABPs may impact the ability of th... Class I Arrow International 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.