Olympus Inner Sheath Medical Device Recall for Ceramic Tip Breakage
Olympus recalls 91 units of its Inner Sheath Model A4741 medical device after receiving complaints of the ceramic tip breaking during gynecological endoscopic procedures.
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 a risk-of-harm medical device where injury has not yet been reported. The FDA Class II classification indicates the device may cause medically reversible adverse health consequences, and the ceramic tip breaking during gynecological endoscopy poses significant risk of patient injury.
Plain-English summary
Olympus Corporation of the Americas is recalling 91 units of its Inner Sheath Model A4741 medical device. This device is used for endoscopic diagnosis and treatment in gynecological applications. The recall is being issued because complaints have been received of the ceramic tip of the resection sheath breaking. The affected units were distributed nationwide in the United States. All lots of Model No. A4741 with UDI 04042761006514 are included in this recall. Healthcare facilities and patients should immediately stop using the affected devices and contact Olympus for return instructions.
The recalled product
- Product
- Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 91
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. A4741
- UDI: 04042761006514
- 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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