Brand Name: Olympus HALO PKS Cutting Forceps — Class II medical device recall Z-1641-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-04-01, distributed nationwide. Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately valid
| Recall number | Z-1641-2026 |
|---|---|
| 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 | 2026-02-25 |
| Classified | 2026-03-25 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, JP, KR, MX, SG |
| Quantity | 2,648 units |
| UPC / GTIN / UDI-DI | 00821925036390 |
| Model numbers | HACF0533 |
Product
Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.
Reason for recall
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
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-1641-2026. 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.