Reported May 22, 2024 · Ongoing
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Karl Storz Endoscopy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Karl Storz Endoscopy · 2151 E Grand Ave · El Segundo, CA · 90245-5017
Is this the product you have?
- LASER Application Instrument, 23 cm
- REF8694; LEUNIG-GREVERS LASER Application
- REF461000
- Lot codes and dates
- All lots
- REF/UDI-DI
8694/04048551216392461000/04048551164860
- Amount recalled
- 85
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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