FDA Device recall Z-1262-2022
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
- FDA Device
- Class II
- ongoing
- Published 2022-06-22
On 2022-06-22 the FDA classified a Class II recall of Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5 by Olympus, citing incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1262-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-20 |
| Published | 2022-06-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | CA, FL, MA, MD, MI, NJ, OH, PR, WI |
Product
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
Reason
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
Identifiers
| code_info | UDI-DI: 04953170339417 Serial Number: 2456630 7171632 2769732 W501648A 2355088 2557155 2972060 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1262-2022%22
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