FDA Device recall Z-1640-2026
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An a…
- FDA Device
- Class II
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class II recall of Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An a… by Olympus, citing 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 Fo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1640-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-25 |
| Published | 2026-04-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Olympus |
| Distribution | US |
Product
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.
Reason
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.
Identifiers
| code_info | Model: PK-CF0533; UDI: 00821925035867; Lot Numbers: All unexpired; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1640-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.