The Recall Desk
HighFDA (Devices)·Z-1234-2022·Announced 2022-06-15

Endoscope models recalled for image loss during electrocautery activation

Karl Storz endoscope models may lose image when monopolar electrocautery is activated. The recall affects 401 units distributed to hospitals in 33 U.S. states and Canada.

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 an FDA Class II recall involving a functional failure during active medical use. No adverse events are reported in the source material. The loss of image during electrocautery represents a risk-of-harm scenario where injury has not yet been reported, consistent with the High severity criterion.

Plain-English summary

Karl Storz Endoscopy is recalling multiple models of CMOS Video Cysto-Urethroscope endoscopes. The affected models are REF 11272VUE, 11272VUEK, 11272VUE-R, and 11272VUEK-R. A total of 401 units were distributed worldwide, including to hospitals and surgical centers in 33 U.S. states and Canada.

The endoscopes may experience a loss of image when monopolar electrocautery is activated during surgical procedures. This problem is caused by a manufacturing assembly process defect affecting specific units identified by serial number.

Hospitals and surgical centers using these devices should immediately verify whether they have units matching the recalled serial numbers. Affected facilities should contact Karl Storz Endoscopy for instructions on the next steps, which may include repair, replacement, or return of the affected devices. Do not use affected units until the defect has been resolved.

The recalled product

Product
STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT
Manufacturer
Karl Storz Endoscopy
Category
Medical Device — Surgical Endoscopes
Hazard
Affected units
401

Distribution

Distributed nationwide across the United States.

The notice also names 36 states specifically:

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