Olympus Gynecological Resection Sheath Recalled Over Ceramic Tip Breakage
Olympus is recalling 899 units of its 8 mm Resection Sheath (Model A42011A) used in gynecological procedures after receiving complaints that the ceramic tip can break during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a medical device where the ceramic tip can break during gynecological procedures, posing a risk of patient harm. Although no injuries or illnesses were reported in the source text, the potential for physical harm from a device component failure during a medical procedure warrants a High severity rating under the risk-of-harm criterion.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Resection Sheath, 8 mm, Model No. A42011A, a device used for gynecological applications. The recall covers all lots of the device, identified by UDI 04042761023658.
The recall is being issued because complaints have been received reporting that the ceramic tip of the resection sheath can break. No additional details regarding the nature or consequences of the breakage were provided in the recall notice.
The affected units were distributed nationwide in the United States. A total of 899 units are included in the recall.
Healthcare facilities and users who have the recalled sheaths should follow the recall notification procedures provided by Olympus Corporation of the Americas. Any questions or concerns should be directed to the recalling firm.
The recalled product
- Product
- Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 899
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. A42011A
- UDI: 04042761023658
- All Lots.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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