Olympus Inner Sheath 21 Fr. Model A2660T Medical Device Recall
Olympus is recalling all lots of its Inner Sheath 21 Fr. Model A2660T used in urological procedures due to reports of the ceramic tip breaking 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a medical device used in urological procedures where the ceramic tip can break during use, which poses a risk of patient injury. Per the rubric, FDA Class II recalls with potential for harm are scored as Severe (4).
Plain-English summary
Olympus Corporation of the Americas is recalling all lots of the Olympus Inner Sheath 21 Fr. Model No. A2660T, a medical device used for endoscopic diagnosis and treatment in urological applications. The recall is being issued in response to complaints that the ceramic tip of the resection sheath can break during use.
The device was distributed nationwide in the United States. The recall includes all units of Model No. A2660T with UDI 04042761004183, regardless of lot number.
Healthcare facilities and users should immediately stop using the affected devices and contact Olympus Corporation of the Americas to arrange for replacement or return of the recalled units. Any adverse events or quality problems experienced with these devices should be reported to the FDA.
The recall is classified as FDA Class II, indicating that use of or exposure to the device may cause temporary or medically reversible adverse health consequences, or where the probability of serious health consequences is not considered to be remote.
The recalled product
- Product
- Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1
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. A2660T
- UDI: 04042761004183
- 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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