Endoscopic Forceps May Fail to Open When Shaft Bent
Surgical grasping forceps may fail to open when the endoscope shaft is bent, potentially affecting their use during endoscopic procedures.
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 is an FDA Class II medical device recall with a mechanical failure that prevents proper function during endoscopic procedures. No injuries or hospitalizations have been reported. The device presents a risk of harm through procedural complications, meeting the criteria for a High-severity recall.
Plain-English summary
Richard Wolf GmbH is recalling 319 units of FLEX. GRASP. FORCEPS 5FR WL 550MM (Product Number 8735.685), a surgical instrument used in endoscopic procedures. The device is identified by UDI/DI: 04055207020265, with multiple affected lot numbers.
The forceps may fail to open their jaws when the endoscope shaft is bent approximately 90 degrees. If the proximal forceps shaft is also bent, the forceps may not open at all, or restrictions may occur even with slight endoscope bending. This mechanical failure could impair clinical procedures.
The affected units have been distributed worldwide to medical facilities and distributors in the United States and over 40 additional countries.
The recalled product
- Product
- FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685
- Manufacturer
- Richard Wolf GmbH
- Hazard
- mechanical-failure
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: 04055207020265
- Lot Numbers: 4500377618
- 4500377296
- 4500374239
- 4500371819
- 4500367415
- 4500363102
- 4500367414
- 4500363666
- 4500359744
- 4500357831
- 4500354319
- 4500352415
- 4500349678
- 4500344619
- 4500347121
- 4500348605
- 4500341300
- 4500338554
- 4500337773
Distribution
Distributed nationwide across the United States.
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