CLASS II ONGOING Device recall · Reported 18 May 2022 · FDA Enforcement Report

11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) recalled

Karl Storz Endoscopy is recalling 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019), distributed nationwide in the US. The recall was initiated on 1 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018

Quantity recalledAll Serial Numbers manufactured/distributed since January 2018

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1055-2022
FDA event ID: 89881
Recalling firm: Karl Storz Endoscopy, El Segundo, CA
Classification: Class II
Status: Ongoing
Recall initiated: 1 Apr 2022
FDA classified: 10 May 2022
Reported: 18 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

1 Apr 2022	Recall initiated by company
10 May 2022	Classified by FDA	+39 days
18 May 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)

Where it was distributed

U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.

Nationwide Florida Kentucky Louisiana Massachusetts Michigan Missouri Montana North Carolina New Hampshire New Jersey Oklahoma South Carolina Texas Washington

Questions about this recall

Why was it recalled?

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Which lots are affected?

11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018

Where was it sold?

U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 89881

Reported	Class	Recall	Company	Reason	Where
18 May 2022	CLASS II	11001RD1 11001RDK1 Karl Storz Slim Nasopharyngolaryngoscope recalled	Karl Storz Endoscopy	Device Malfunction	Nationwide

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