The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1424-2023·Announced 2023-05-03

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category
Medical Device — Endoscopic Instruments
Hazard
Affected units
319

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.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Richard Wolf GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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