Z-2447-2019Class II

Flexible Intubation Fiberscope, Model # 11301AB1

Name: Z-2447-2019 Flexible Intubation Fiberscope, Model # 11301AB1
Creator: Karl Storz Endoscopy
Published: 2019-04-24
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2019-04-24 / Terminated / root cause: manufacturing process

FDA source

Karl Storz Endoscopy began a recall of Flexible Intubation Fiberscope, Model # 11301AB1 on 2019-04-24. FDA classified it as Class II and gives the reason as "The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2447-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-24
Posted: 2019-08-31
Terminated: 2020-12-04
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: Flexible Intubation Fiberscope, Model # 11301AB1
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm mailed a "safety alert" on April 24, 2019 via FedEx. 2nd day delivery. The safety alert advised customers to do the following: 1. If you use the following automated processes, the high level disinfection/liquid chemical sterilization of the flexible endoscope cannot be guaranteed: Reprocessing Method Impact, Medivators AER * Patient Safety may be Compromised, STERIS System 1E (SS1E)** Patient Safety may be Compromised The above connectors can only connect onto one port, therefore leaving the other port open. Depending on the reprocessing system, the cycle could result in an error or in successful completion of the cycle. " If an error code is displayed, the user would know the cycle is not complete and the scope has not been successfully reprocessed. " If the cycle is completed without an error code, the high-level disinfection/liquid chemical sterilization of the flexible endoscope cannot be guaranteed. Improper reprocessing may result in incomplete decontamination, which may result in a cross-contamination patient infection. If you use Medivators AER or STERIS SS1E to reprocess this scope, please be aware of the possible risks and take the necessary actions to address any patient safety concerns. 2. Please complete the attached Action Requested form and follow the instructions outlined on the form. 3. you have any questions please contact the following person: This Recall Action, Emily Cuadros, Complaint Handling , 424-218-8289 Reprocessing, Shaun McGinley, Director of Reprocessing, 424-218-8247 Patient Safety, Dr. Dennis Fowler, Chief Medical Officer, 424-218-8603
Quantity in commerce: 14 scopes
Distribution: US: VA, MO, CA, OH, NM, NY, CO, LA, ME, OUS: Canada
Product codes and lots: Lot numbers: 2183827, 2195794, 2215741, 2229258, 2235373, 2248169, 2193769

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2447-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2447-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-08-31

Product code EOQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)