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.
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. 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
- Affected units
- 207
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.
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
- HighUroPass Ureteral Access Sheaths Recalled for Dilator Tip Breakage
FDA (Devices) · 2023-08-23
- HighOlympus Cystoscope Outer Sheath Recalled Due to Potential Device Tip Damage
FDA (Devices) · 2026-03-04
- SevereOlympus Guide Sheath Kits recalled for potential radiopaque tip detachment
FDA (Devices) · 2025-02-19
- 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
- HighOlympus BiCOAG Hemostasis Probe Recalled for Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30