The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1425-2023·Announced 2023-05-03

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.

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 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
Category
Medical Device — Surgical / Endoscopic Instruments
Hazard
Affected units
280

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.

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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