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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
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Dec 31, 2025 Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 ... Products were mislabeled as the 6mm product but included the 5 mm product. Class II Centinel Spine, Inc.
Dec 29, 2025 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Materia... Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring si... Class II Siemens Medical Solutions USA, Inc
Dec 29, 2025 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Materia... Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring si... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification ... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist ... The supplier manufactured anatomical left plates with an incorrect thread orientation. Class II Tyber Medical
Dec 19, 2025 NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification sy... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist ... The supplier manufactured anatomical left plates with an incorrect thread orientation. Class II Tyber Medical
Dec 11, 2025 Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Ca... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog ... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges ... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 8155... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog ... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: ... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 5, 2025 LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software ve... Class II Siemens Medical Solutions USA, Inc
Nov 24, 2025 Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. A certain component of affected devices was not delivered within specification and contained impu... Class I Draeger, Inc.
Nov 24, 2025 Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer. A certain component of affected devices was not delivered within specification and contained impu... Class I Draeger, Inc.
Nov 14, 2025 Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-... Ongoing investigations identified additional instances of the device Generator remaining in a bli... Class II Olympus Corporation of the Americas
Nov 14, 2025 Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse... Ongoing investigations identified additional instances of the device Generator remaining in a bli... Class II Olympus Corporation of the Americas
Nov 14, 2025 Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lit... Ongoing investigations identified additional instances of the device Generator remaining in a bli... Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological ... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatmen... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagn... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for uro... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for uro... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and t... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and tre... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. R... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatmen... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic appl... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gyne... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. ... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for ur... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological ... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 11, 2025 Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treat... Complaints of the ceramic tip of the resection sheath breaking have been received. Class II Olympus Corporation of the Americas
Nov 10, 2025 ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for c... Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. Class I Draeger, Inc.
Nov 10, 2025 ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for condu... Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. Class I Draeger, 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.