[pending] Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/C
Pending LLM rewrite. Source: FDA_DEVICE Z-1643-2026.
What this means for you
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: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
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: 920000PK
- UDI: 00821925038080
- Lot Numbers: All unexpired
Distribution
Distributed nationwide across the United States.
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