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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

407 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 407 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 407 FDA device recalls.

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DateProductReasonClassFirm
Jan 7, 2026 Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Mod... 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 (Distal Wire guided) Model... 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 (Distal Wire guided) Model... 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 (Distal Wire guided) Model... 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: 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
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
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
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 22, 2025 Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 45 cm Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat 5 mm, 10 cm, Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas

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.