CLASS II Device recall · Reported 22 Nov 2017 · FDA Enforcement Report
Storz High Flow Insufflation Tubing (with filter) recalled
Karl Storz Endoscopy is recalling Storz High Flow Insufflation Tubing (with filter), distributed nationwide in the US. The recall was initiated on 10 Oct 2017 and the FDA has classified it as Class II.
Check your package
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-0098-2018
- FDA event ID
- 78289
- Recalling firm
- Karl Storz Endoscopy, El Segundo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Oct 2017
- FDA classified
- 16 Nov 2017
- Reported
- 22 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Surgical Instruments
Timeline
| 10 Oct 2017 | Recall initiated by company | |
| 16 Nov 2017 | Classified by FDA | +37 days |
| 22 Nov 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.
Product as listed by the FDA
STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard box are incorrectly labeled as Catalog number 20400162S, High Flow Insufflation Tubing (with filter) For 26432020-1 THERMOFLATOR. The firm name on the label is Karl Storz Endoscopy-America, Inc., El Segundo, CA.
Where it was distributed
Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.
Questions about this recall
Why was it recalled?
The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.
Which lots are affected?
Lot #129241
Where was it sold?
Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.
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.
More recalls from Karl Storz Endoscopy
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|---|---|---|---|---|---|
| Device | CLASS II | Flexible Hystero-Fiberscope Kits recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Sterility | Nationwide |
| Device | CLASS II | Karl Storz - Endoskope recalled | Karl Storz Endoscopy | Other | Nationwide |
| Device | CLASS II | Karl Storz - Endoskope recalled | Karl Storz Endoscopy | Other | Nationwide |
| Device | CLASS II | Karl Storz - Endoskope recalled | Karl Storz Endoscopy | Other | Nationwide |
| Device | CLASS II | Karl Storz - Endoskope recalled | Karl Storz Endoscopy | Other | Nationwide |
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