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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | XXX | Class II | Olympus Corporation of the Americas |
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
| Feb 27, 2026 | Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTI... | Following a complaint investigation, Olympus identified a potential defect in the 24V power suppl... | Class II | Olympus Corporation of the Americas |
| Feb 27, 2026 | Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: S... | Following a complaint investigation, Olympus identified a potential defect in the 24V power suppl... | Class II | Olympus Corporation of the Americas |
| 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 |
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.