Surgical forceps may fail to open during endoscopic procedures
Richard Wolf surgical forceps may fail to open when the endoscope shaft is bent. Affected units distributed worldwide; users should check lot numbers and discontinue use if affected.
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: This FDA Class II recall concerns surgical forceps with a mechanism that may fail to open under specific conditions during endoscopic use. As a risk-of-harm product that could affect procedure outcomes, it meets High severity criteria.
Plain-English summary
Richard Wolf GmbH has recalled 280 units of FLEX. GRASP. FORCEPS 6.6FR WL 550MM (Product Number 8736.685) due to a potential malfunction in the device's jaw opening mechanism.
Under certain conditions—specifically when the endoscope shaft is bent approximately 90 degrees—the forceps jaws may not open. If the proximal forceps shaft is also bent, the jaws cannot open at all, or operation becomes severely restricted even with minimal bending.
The affected forceps were distributed worldwide, including throughout the United States and internationally. The recall involves 20 specific lot numbers. Healthcare facilities using these devices should verify their inventory against the provided lot numbers.
Users with affected units should discontinue use and contact Richard Wolf GmbH for instructions.
The recalled product
- Product
- FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685
- Manufacturer
- Richard Wolf GmbH
- Hazard
- device-malfunction
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 (20)
- UDI/DI: 04055207020289
- Lot Numbers: 4500377853
- 4500371811
- 4500377297
- 4500371813
- 4500367418
- 4500367417
- 4500363668
- 4500363104
- 4500359203
- 4500356576
- 4500353566
- 4500352416
- 4500350353
- 4500347761
- 4500346491
- 4500344550
- 4500341309
- 4500338558
- 4500334010
Distribution
Distributed nationwide across the United States.
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