Olympus Inner Sheath Long Model WA22017T Recalled Due to Potential Ceramic Tip Breakage
Olympus Corporation of the Americas is recalling Olympus Inner Sheath, Long (Model No. WA22017T) because the ceramic tip may 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: The product is a medical device with a high-risk hazard (fragmentation/breakage) where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling Olympus Inner Sheath, Long; Model No. WA22017T. This device is an inner sheath used for urological and gynecological applications.
The recall was initiated following complaints that the ceramic tip of the resection sheath may break.
This recall affects 1,141 units distributed nationwide in the United States.
The recalled product
- Product
- Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,141
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. WA22017T
- UDI: 04042761051521
- 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
- HighOlympus Recalls High Frequency Resection Electrodes Due to Wire Breakage
FDA (Devices) · 2017-07-05
- SevereOlympus Guide Sheath Kits recalled for potential radiopaque tip detachment
FDA (Devices) · 2025-02-19