Olympus resection sheath recalled due to ceramic tip breakage
Olympus is recalling 207 units of its Resection Sheath, Model A22043T, after receiving complaints that the ceramic tip can break during use. The recall affects all lots distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. The device is a medical device used in urologic procedures, and the reported ceramic tip breakage poses a risk of harm during use. Per the rubric, FDA Class II recalls with risk-of-harm products where injury has not yet been reported are classified as Severe (score 4).
Plain-English summary
Olympus Corporation of the Americas is recalling 207 units of the Olympus Resection Sheath, 28 Fr. with Deflecting Obturator, Model No. A22043T. The device is a resection sheath intended for urologic applications.
The recall is being issued because complaints have been received reporting that the ceramic tip of the resection sheath can break. No other information about the cause or frequency of the breakage was provided in the recall notice.
The recalled devices were distributed nationwide in the United States. The recall includes all lots of Model A22043T with UDI 04042761021012.
Healthcare facilities and users should discontinue use of the affected devices and contact Olympus Corporation of the Americas regarding the recall. Consumers or patients with questions should consult their healthcare provider.
The recalled product
- Product
- Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- device-breakage
- ceramic-tip-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. A22043T
- UDI: 04042761021012
- All Lots.
Distribution
Distributed nationwide across the United States.
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