Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 13, 2016
ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL
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 chann…
The recall
Karl Storz Endovision, Inc. issued this moderate-severity FDA Devices recall — Endoscope cleaning brush 11276CL may not fit resulting in an inability to insert the brush in to the channel….
- Moderate
- severity level
- Class II
- classification
- April 13, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1333-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1333-2016) was formally reported on April 13, 2016, with the manufacturer initiating the action on February 29, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Karl Storz Endovision, Inc. is listed as the recalling firm, operating out of Charlton, MA. Federal records list the affected scope as 16908 brushes.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide Foreign: Canada, Mexico,. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 27,303 medical devices recalls on record
Where this recall sits in the database
Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.
Affected scope
16908 brushes
Related Recalls
6
6 from same agency
Product description
ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1333-2016 |
| Date reported | April 13, 2016 |
| Date initiated | February 29, 2016 |
| Recalling firm | Karl Storz Endovision, Inc. |
| Firm location | Charlton, MA |
| Affected scope | 16908 brushes |
| Distribution | Nationwide Foreign: Canada, Mexico, |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL. Recalled by Karl Storz Endovision, Inc.. Units affected: 16908 brushes.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2016. Severity: Moderate. Recall number: Z-1333-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide Foreign: Canada, Mexico,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1333-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported April 13, 2016.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).