Z-1333-2016Class II

ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various...

Name: Z-1333-2016 ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various...
Creator: Karl Storz Endovision, Inc.
Published: 2016-02-29
License: https://open.fda.gov/license/

KARL STORZ Endovision, Inc. / initiated 2016-02-29 / Terminated / root cause: design

FDA source

Karl Storz Endovision, Inc. began a recall of ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL on 2016-02-29. FDA classified it as Class II and gives the reason as "Endoscope cleaning brush 11276CL may not fit resulting in an inability to insert the brush in to the channel of the intended endoscope or to completely pass it through such channel". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1333-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-29
Posted: 2018-10-02
Terminated: 2016-09-28
Recalling firm: KARL STORZ Endovision, Inc.
Product: ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL
Product code: MNL Accessories, Cleaning Brushes, For Endoscope
Reason for recall: Endoscope cleaning brush 11276CL may not fit resulting in an inability to insert the brush in to the channel of the intended endoscope or to completely pass it through such channel.
Root cause tag: design
FDA root cause: Component design/selection
Action: Karl Storz issued Recall Letter to users on 12/23/15. Firm's letter: KARL STORZ has identified a replacement brush; model 11276CL2 that is now available to clean your endoscope. Please check your inventory and remove any model 11276CL brushes. These brushes must be returned to KARL STORZ. Please complete the attached form and followthe return instructions. Upon receipt of any 11276CL brushes from you we will provide you the 11276CL2 cleaning brush as replacement at no charge. Contact Lynn Carter, Director Quality Assurance at 508-248-9011, extension 1664 Monday through Friday, 8:00AM to 4:30PM, Eastern Time.
Quantity in commerce: 16908 brushes
Distribution: Nationwide Foreign: Canada, Mexico,
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1333-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1333-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-05

Product code MNL

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)