Recall Z-1809-2024— Karl Storz Endoscopy

Name: FDA recall Z-1809-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-01

Class II · Ongoing

Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2024-04-01. It names one FDA 510(k) clearance: K942786. Product: LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000. Reason: Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection..

Recalling firm: Karl Storz Endoscopy
Classification: Class II
Status: Ongoing
Initiated: 2024-04-01
Firm location: El Segundo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K942786 — KARL STORZ LASER ACCESSORIESKARL STORZ Endoscopy-America, Inc.·cleared 1994-09-16

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

LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000

Reason for recall

Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.

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