Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

389 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 389 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 389 FDA device recalls.

Clear
DateProductReasonClassFirm
Feb 25, 2026 Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PK... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Produc... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Fo... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS C... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 12, 2026 Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... Class II Olympus Corporation of the Americas
Feb 12, 2026 Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... Class II Olympus Corporation of the Americas
Feb 12, 2026 Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... Class II Olympus Corporation of the Americas
Feb 12, 2026 Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... Class II Olympus Corporation of the Americas
Jan 29, 2026 Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per... Potential for rubber fragment detachment during use. Class II Olympus Corporation of the Americas
Jan 29, 2026 Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per ... Potential for rubber fragment detachment during use. Class II Olympus Corporation of the Americas
Jan 16, 2026 Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insuffla... Issue with software algorithm which may lead to overpressure events. Class I Olympus Corporation of the Americas
Jan 16, 2026 Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insuf... Issue with software algorithm which may lead to overpressure events. Class I Olympus Corporation of the Americas
Jan 16, 2026 Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insuff... Issue with software algorithm which may lead to overpressure events. Class I Olympus Corporation of the Americas
Jan 8, 2026 Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product ... Mis-wired component-the improperly wired component can result in additional noise on the power su... 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: 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: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog... 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 Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable ... 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 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: 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: 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 (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 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

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.