Olympus resection inner sheath A22040A recalled over ceramic tip breakage
Olympus is recalling its Resection Inner Sheath for 26 Fr outer sheath, model A22040A, used in urologic applications, after complaints that the ceramic tip can break.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a device that can break during a procedure, with no injuries or hospitalisations stated in the source.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Resection Inner Sheath for 26 Fr outer sheath, model number A22040A, a resection sheath for urologic applications. About 6,949 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
Complaints of the ceramic tip of the resection sheath breaking have been received.
All lots are affected. The device carries UDI 04042761029339.
Facilities can identify affected devices by the model number and UDI above, and may contact Olympus Corporation of the Americas for further information.
The recalled product
- Product
- Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Affected units
- 6,949
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. A22040A
- UDI: 04042761029339
- 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.
See all 20 products in this recall →Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
- ModerateOlympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
Same hazard · device breakage
See all →- HighTissium Peripheral Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighPeripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighTissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01
- SevereSurgify Halo 4.0mm Extendable Surgical Burr Recall for Breakage Risk
FDA (Devices) · 2026-07-01
Similar recalls
- HighOlympus Cystoscope Outer Sheath Recalled Due to Potential Device Tip Damage
FDA (Devices) · 2026-03-04
- HighUroPass Ureteral Access Sheaths Recalled for Dilator Tip Breakage
FDA (Devices) · 2023-08-23
- HighOlympus UroPass Ureteral Access Sheaths recalled for UV-induced brittleness
FDA (Devices) · 2024-11-20
- HighOlympus Thunderbeat II Shears recall due to distal tip detachment
FDA (Devices) · 2026-04-29
- HighCystoscope Outer Sheath Recalled for Potential Laser Probe Damage
FDA (Devices) · 2024-11-20
- HighOlympus Recalls Urologic Endoscopic Working Inserts and Bridges Due to Adhesive Fragments
FDA (Devices) · 2018-03-07