Olympus Corporation of the Americas
286 federal recalls on file, showing the 122 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Olympus Corporation of the Americas and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-04FDA-DeviceClass IIStop using Olympus resection sheath Model A2666
Olympus has recalled its Model A2666 resection sheath, a medical device used in urologic procedures, because the ceramic tip can break during use. The FDA has classified this as a Class II recall affecting all lots of this device.
- 2026-03-04FDA-DeviceClass IIStop using Olympus WA22017T inner sheath
Olympus has recalled its Inner Sheath, Long (Model WA22017T) used in urological and gynecological procedures because the ceramic tip of the resection sheath can break during use. The company received multiple complaints about this defect. About 1,141 units are affected nationwide.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Inner Sheath WA22017A
Olympus has recalled its Inner Sheath Long (Model WA22017A), a medical device used in urological and gynecological procedures. The ceramic tip on the resection sheath can break during use. The FDA has classified this as a Class II recall affecting 437 units distributed nationwide.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Inner Sheath Model A4741
The ceramic tip on Olympus Inner Sheath Model A4741, used in gynecological endoscopy procedures, can break during use. The FDA has received complaints of this breakage. Approximately 91 units are affected nationwide.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Resection Sheath Model A42011A
The ceramic tip on Olympus Resection Sheath Model A42011A (8 mm) can break during use. This gynecological surgical instrument is used in medical procedures, and a broken tip could create complications. No injuries have been reported, but the FDA is recalling all units as a precaution.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Inner Sheath Model A2660
Olympus has recalled the Inner Sheath Model A2660, a medical device used in urological procedures. The ceramic tip of the resection sheath can break during use, which could affect the safety and effectiveness of the procedure.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Resection Sheath A22043T
The ceramic tip on Olympus Resection Sheath Model A22043T (28 Fr. with Deflecting Obturator) can break during use. This device is used in urologic surgical procedures. The FDA has identified 207 affected units across the US.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Resection Sheath 28 Fr.
The ceramic tip on Olympus Resection Sheath model A22043A can break during use. This is a medical device used in urologic procedures. No injuries have been reported, but the broken tip could affect the device's function.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Resection Sheath A22042T
Olympus Corporation of the Americas is recalling the Resection Sheath 26 Fr. with Deflecting Obturator (Model A22042T), a medical device used in urologic procedures. The ceramic tip on this device can break during use, which may affect the procedure or patient safety.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Resection Sheath Model A22042A
Olympus has recalled its Resection Sheath 26 Fr. (Model A22042A) used in urologic procedures because the ceramic tip can break during use. The company has received complaints about this defect. All lots of this device are affected.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Resection Sheath Model A22041T
Olympus is recalling a urologic resection sheath because the ceramic tip can break during use. This affects Model No. A22041T units distributed nationwide. No injuries have been reported, but a broken tip could affect the device's function.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Resection Sheath 24 Fr
Olympus has recalled the Resection Sheath, 24 Fr (Model A22041A), a urologic medical device, because the ceramic tip can break during use. The company has received multiple complaints about this problem. About 3,484 units are affected nationwide.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Resection Inner Sheath A22040T
Olympus has recalled a urologic resection sheath (Model A22040T) because the ceramic tip can break during use. The FDA has classified this as a Class II recall, meaning the defect could cause serious harm. No injuries have been reported so far.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Resection Inner Sheath Model A22040A
Olympus has recalled a urologic resection sheath (Model A22040A) because the ceramic tip can break during use. The FDA has classified this as a Class II recall affecting 6,949 units distributed nationwide. No injuries have been reported.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Resection Sheath immediately
The ceramic tip on Olympus Resection Sheath models A22014A and A22014T can break during use. These devices are used by doctors during urological procedures. The company has received complaints about this issue affecting 29 units nationwide.
- 2026-03-04FDA-DeviceClass IIStop using Olympus Cystoscope Outer Sheath WA22810A
Olympus is recalling the Cystoscope Outer Sheath model WA22810A because it is incompatible with GreenLight Laser systems used for prostate (BPH) treatment. Using this sheath with the laser can damage the tip of the device, potentially affecting the safety and function of the cystoscope.
- 2026-02-25FDA-DeviceClass IIStop using Olympus Thunderbeat surgical instruments
Olympus Corporation is recalling the Thunderbeat 5 mm, 10 cm surgical instrument (Model TB-0510IC) worldwide due to continued reports of adverse events during use. The company has decided to remove all 1,538 units from distribution.
- 2026-02-25FDA-DeviceClass IIStop using Olympus Thunderbeat surgical devices
Olympus Corporation is removing Thunderbeat 5 mm, 20 cm surgical instruments from the market due to ongoing reports of adverse events during use. About 140 units with model number TB-0520IC have been distributed worldwide, including across the US and in Brazil, Canada, Germany, Mexico, and Japan.
- 2026-02-25FDA-DeviceClass IIStop using Olympus Thunderbeat surgical instruments
Olympus is recalling the Thunderbeat 5 mm, 35 cm inline grip surgical instrument (Model TB-0535IC) due to ongoing reports of adverse events during use. This medical device is used in surgical procedures and distributed worldwide.
- 2026-02-25FDA-DeviceClass IIStop using Olympus Thunderbeat surgical instruments
Olympus Corporation is removing Thunderbeat 5 mm, 45 cm Inline Grip surgical instruments (Model TB-0545IC) due to continued reports of adverse events during use. The recall affects 30 units distributed worldwide, including the United States, Brazil, Canada, Germany, Mexico, and Japan.
- 2026-02-25FDA-DeviceClass IIStop using Olympus Thunderbeat surgical instruments
Olympus Corporation is removing Thunderbeat 5mm pistol grip surgical instruments (Model TB-0535PC) from the market worldwide due to ongoing reports of adverse events during use. No specific injuries have been reported, but the company is taking action out of caution.
- 2026-02-25FDA-DeviceClass IIStop using Olympus Thunderbeat surgical instruments
Olympus Corporation is removing Olympus Thunderbeat 5 mm, 45 cm pistol grip surgical instruments (Model TB-0545PC) from the market due to ongoing reports of adverse events during use. This Class II recall affects approximately 30 units distributed worldwide, including the United States, Brazil, Canada, Germany, Mexico, and Japan.
- 2026-02-25FDA-DeviceClass IIStop using Olympus Thunderbeat surgical instruments
Olympus Corporation is recalling the Thunderbeat 5 mm, 20 cm front-actuated grip surgical instrument due to continued reports of adverse events during use. The recall affects all lots of this model worldwide, including the US and several other countries.
- 2026-02-25FDA-DeviceClass IIStop using Olympus Thunderbeat 5mm instruments
Olympus is removing the Thunderbeat 5 mm, 35 cm, Front-Actuated Grip surgical instrument (Model TB-0535FC) from distribution due to ongoing reports of adverse events during use. The device has been distributed worldwide, including across the US and several other countries.
- 2026-02-25FDA-DeviceClass IIStop using Olympus Thunderbeat surgical instruments
Olympus is recalling the Thunderbeat 5 mm, 45 cm Front-Actuated Grip surgical instrument (Model TB-0545FC) worldwide due to continued reports of adverse events during use. The company has determined that removal of this device from the market is necessary.
- 2026-02-25FDA-DeviceClass IIStop using Olympus Thunderbeat instruments
Olympus Corporation is removing Thunderbeat 5 mm, 20 cm surgical instruments (Model TB-0520FCS) from the market due to ongoing reports of adverse events during use. The company has identified a safety concern affecting all lots of this device.
- 2026-02-25FDA-DeviceClass IIStop using Olympus Thunderbeat devices
Olympus is recalling its Thunderbeat 5 mm, 35 cm Front-Actuated Grip Type S surgical instruments (Model TB-0535FCS) due to ongoing reports of adverse events. The recall affects 88,268 units distributed worldwide, including in the United States, Brazil, Canada, Germany, Mexico, and Japan.
- 2026-02-25FDA-DeviceClass IIStop using Olympus Thunderbeat surgical instruments
Olympus Corporation is removing the Thunderbeat 5 mm, 45 cm Front-Actuated Grip Type S surgical instrument from use worldwide due to ongoing reports of adverse events during use. This affects approximately 9,542 units across the US and several other countries.
- 2026-02-25FDA-DeviceClass IContact Olympus about UHI-3 insufflation unit recall
Olympus has recalled the High Flow Insufflation Unit Model UHI-3 due to a software algorithm issue that can cause overpressure events during abdominal cavity insufflation procedures. This medical device is used in laparoscopic surgery to maintain proper pressure and clear the surgical field. No injuries have been reported.
- 2026-02-25FDA-DeviceClass IStop using Olympus UHI-2 insufflation units
Olympus has recalled its High Flow Insufflation Unit (Model UHI-2) used during abdominal surgery because a software problem may cause the device to create excessive pressure in the abdominal cavity. The issue affects all 744 units distributed nationwide. No injuries have been reported.
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