Browse Device Recalls

2,862 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,862 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 2,862 FDA device recalls in PA.

Date	Product	Reason	Class	Firm
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.
Nov 10, 2025	ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for co...	Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.	Class I	Draeger, Inc.
Nov 10, 2025	ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for c...	Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.	Class I	Draeger, Inc.
Oct 30, 2025	Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Mod...	Potential that the ligation loop was unable to release or detach as expected during use, causing ...	Class I	Olympus Corporation of the Americas
Oct 29, 2025	Outlook set utilized in gravity IV administration sets and pump administratio...	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con...	Class II	B Braun Medical Inc
Oct 29, 2025	IV Administration Set utilized in gravity IV administration sets and pump adm...	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con...	Class II	B Braun Medical Inc
Oct 29, 2025	IV Administration Set utilized in gravity IV administration sets and pump adm...	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con...	Class II	B Braun Medical Inc
Oct 29, 2025	Extension Set utilized in gravity IV administration sets and pump administrat...	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con...	Class II	B Braun Medical Inc
Oct 29, 2025	Anesthesia IV Set utilized in gravity IV administration sets and pump adminis...	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con...	Class II	B Braun Medical Inc
Oct 29, 2025	B.BRAUN utilized in gravity IV administration sets and pump administration se...	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con...	Class II	B Braun Medical Inc
Oct 29, 2025	IV Administration Set utilized in gravity IV administration sets and pump adm...	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con...	Class II	B Braun Medical Inc
Oct 29, 2025	IV Administration Set utilized in gravity IV administration sets and pump adm...	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con...	Class II	B Braun Medical Inc
Oct 29, 2025	IV Administration Set utilized in gravity IV administration sets and pump adm...	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con...	Class II	B Braun Medical Inc
Oct 29, 2025	IV Administration Set utilized in gravity IV administration sets and pump adm...	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con...	Class II	B Braun Medical Inc
Oct 29, 2025	IV Administration Set utilized in gravity IV administration sets and pump adm...	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con...	Class II	B Braun Medical Inc
Oct 29, 2025	SafeDAY set utilized in gravity IV administration sets and pump administratio...	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con...	Class II	B Braun Medical Inc
Oct 29, 2025	Blood Administration Set utilized in gravity IV administration sets and pump ...	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con...	Class II	B Braun Medical 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.