Olympus POWERSEAL 5MM — Class II medical device recall Z-1814-2022
Ongoing recall by Olympus Corporation of the Americas, reported 2022-10-05, distributed nationwide. An out of specification component preventing the blue retention ring from keeping the rotation knob in place.
| Recall number | Z-1814-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2022-08-12 |
| Classified | 2022-09-26 |
| Reported by FDA | 2022-10-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, HK, KR |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00821925044555 |
| Lot numbers | CA191233, CA191234, CA191235, CA233514, CA233515, CA233516, CA233517, CA233518, CA236206, CA236208, CA236213, CA236215, CA236216, CA236217, CA236220, CA236227, CA236228, CA236230, CA236238, CA236240, CA236243, CA236261, CA236272, CA236273, CA236276, CA236278, CA236290 |
| Model numbers | PS-0537CJDA |
Product
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Reason for recall
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1814-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.