Recall Z-1422-2023— Richard Wolf GmbH

Name: FDA recall Z-1422-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-24

Class II · Ongoing

Class II FDA medical device recall by Richard Wolf GmbH, initiated 2023-03-24. It names one FDA 510(k) clearance: K971315. Product: FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051. Reason: Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope..

Recalling firm: Richard Wolf GmbH
Classification: Class II
Status: Ongoing
Initiated: 2023-03-24
Firm location: Knittlingen, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K971315 — AUXILIARY INSTRUMENTS FOR URSRichard Wolf Medical Instruments Corp.·cleared 1997-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051

Reason for recall

Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.

Data sourced from openFDA. This site is unofficial and independent of the FDA.