Olympus
55 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Olympus and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-08FDA-DeviceClass IIStop using affected Olympus SOLTIVE Pro laser units
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
- 2026-04-08FDA-DeviceClass IIStop using affected Olympus SOLTIVE laser systems
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
- 2026-04-01FDA-DeviceClass IIStop using Olympus PKS Cutting Forceps
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- 2026-04-01FDA-DeviceClass IIStop using Olympus PKS Cutting Forceps
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- 2026-04-01FDA-DeviceClass IIStop using Olympus PKS Cutting Forceps
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- 2026-04-01FDA-DeviceClass IIStop using Olympus HALO PKS Cutting Forceps
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- 2026-04-01FDA-DeviceClass IIStop using Olympus PK Cutting Forceps model PK-CF0533
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- 2026-04-01FDA-DeviceClass IIStop using Olympus Everest Bipolar Cutting Forceps
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- 2026-04-01FDA-DeviceClass IIStop using Olympus Everest Bipolar Cutting Forceps
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- 2026-04-01FDA-DeviceClass IICheck your Olympus endoscope reprocessor compatibility
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- 2026-04-01FDA-DeviceClass IICheck your Olympus endoscope reprocessor compatibility
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- 2026-04-01FDA-DeviceClass IIStop using Olympus MAJ-1444 valve with OER reprocessors
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- 2026-04-01FDA-DeviceClass IIStop using Olympus MAJ-1443 suction valve with OER reprocessors
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- 2026-03-11FDA-DeviceClass IIContact Olympus about ShockPulse-SE Lithotripsy System
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.
- 2026-03-11FDA-DeviceClass IIStop using Olympus MAJ-1218 biopsy valves
Potential for rubber fragment detachment during use.
- 2026-03-11FDA-DeviceClass IIStop using Olympus MAJ-210 biopsy valves
Potential for rubber fragment detachment during use.
- 2026-03-11FDA-DeviceClass IIStop using Olympus ShockPulse-SE lithotripsy generators
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
- 2026-03-11FDA-DeviceClass IIContact Olympus about ShockPulse-SE device issues
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
- 2026-03-11FDA-DeviceClass IIStop using Olympus ShockPulse-SE lithotripsy systems
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Resection Sheath A2666T
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Inner Sheath Model A2642
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Inner Sheath Model A2641
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Model A37004A sheaths
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIContact Olympus about recalled urological sheath
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIStop using Olympus resection sheath Model A2666
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIStop using Olympus WA22017T inner sheath
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Inner Sheath WA22017A
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Inner Sheath Model A4741
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Resection Sheath Model A42011A
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Inner Sheath Model A2660
Complaints of the ceramic tip of the resection sheath breaking have been received.
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