Reported Sep 27, 2023 · Ongoing

Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only

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?

  • Five S 5 3x65
  • REF0915612-06, sterile for single use, Sterile EO, Rx Only
Lot codes and dates
  • UDI04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461
Amount recalled
218 units

Where it was sold

Why it was recalled

Flexible intubation endoscopes sterility assurance can not be confirmed.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.