Recall Z-1473-2024— Karl Storz Endoscopy

Name: FDA recall Z-1473-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-27

Class II · Ongoing

Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2024-02-27. It names one FDA 510(k) clearance: K951343. Product: Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE. Reason: Inadequate reprocessing validation evidence.

Recalling firm: Karl Storz Endoscopy
Classification: Class II
Status: Ongoing
Initiated: 2024-02-27
Firm location: El Segundo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K951343 — KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURESKARL STORZ Endoscopy-America, Inc.·cleared 1996-04-11

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

Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE

Reason for recall

Inadequate reprocessing validation evidence

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