The Recall Desk
HighFDA (Devices)·Z-1422-2023·Announced 2023-05-03

Surgical forceps may fail to open when endoscope shaft is bent

Richard Wolf surgical forceps may fail to open when used during endoscopic procedures if the endoscope shaft becomes bent. Approximately 838 units are affected worldwide.

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 a Class II recall of a surgical instrument with a reported malfunction that may prevent the forceps jaws from opening during endoscopic procedures. No illnesses or injuries have been reported. The device presents a potential risk of harm during medical procedures but without reported clinical incidents, meeting the High severity criterion for risk-of-harm products without reported injury.

Plain-English summary

Richard Wolf GmbH is recalling 838 units of FLEX. GRASP. FORCEPS 5FR WL 550MM (Product Number 828.051) due to potential malfunction of the forceps mechanism.

The forceps jaws may become unable to open when the endoscope shaft is bent by approximately 90 degrees. If the proximal forceps shaft is also bent, the forceps may not open at all or may experience restrictions even with slight bending of the endoscope.

The affected units have been distributed worldwide, including the United States and numerous international countries. Healthcare facilities and medical professionals using these forceps during endoscopic procedures may be impacted.

If you have received this product, discontinue use and contact Richard Wolf GmbH for instructions regarding replacement or proper disposal. Report any adverse events related to this device to the FDA.

The recalled product

Product
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
Manufacturer
Richard Wolf GmbH
Category
Medical Device — Endoscopic Forceps
Hazard
  • forceps-jaws-unable-to-open
  • 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: 04055207009574
  • Lot Numbers: 4500377299
  • 4500377299
  • 4500371834
  • 4500374645
  • 4500369724
  • 4500367397
  • 4500363662
  • 4500363096
  • 4500359201
  • 4500356582
  • 4500353558
  • 4500350415
  • 4500347760
  • 4500345769
  • 4500341314
  • 4500338447
  • 4500336245
  • 4500334737
  • 4500334002

Distribution

Distributed nationwide across the United States.

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