Lower riskMedical device recall · FDA · Published October 10, 2017
Karl Storz Endoscopy STORZ High Flow Insufflation Tubing Mislabeling Recall
Karl Storz Endoscopy recalls STORZ High Flow Insufflation Tubing (with filter) due to mislabeled pouches inside cardboard boxes. Affected units have incorrect catalog numbers and may be confused with different products.
“Karl Storz Endoscopy STORZ High Flow Insufflation Tubing Mislabeling Recall.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72874-karl-storz-endoscopy-storz-high-flow-insufflation-tubing-mislabeling-recall. Based on FDA recall #Z-0098-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0098-2018%22&limit=1).
The FDA announced on 2017-10-10 that Karl Storz Endoscopy is recalling STORZ High Flow Insufflation Tubing due to mislabeled pouches inside the boxes, according to FDA records.
How to tell if you have it
Brand: Karl Storz Endoscopy
Product: STORZ High Flow Insufflation Tubing (with filter)
Catalog #: 20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box
Pouch Catalog #: 20400161S
Lot #: 129241
Quantity: 496/10-pouch boxes
Distribution: Nationwide, government distribution, and Canada
The hazard
The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product. Some of the pouches are incorrectly labeled as Catalog number 20400162S, High Flow Insufflation Tubing (with filter) For 26432020-1 THERMOFLATOR.
Context
GovInfoNow's records show Karl Storz Endoscopy has 24 other recalls on record since 2019-01-09. Other recent recalls of similar products include Karl Storz HOPKINS Telescope Recall (2026-08-12), Karl Storz Flexible Hystero-Fiberscope Kits Recall (2026-05-21), and Karl Storz Uretero-Renoscope Recall (2024-12-19). Other recent recalls of similar products include Covidien Shiley Tracheostomy Tube Recall (2026-04-15), W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall (2026-05-22), and Erbe Medical ERBEFLO 2 Endoscopy Pump Tubing Recall (2026-03-31).
How to tell if you have this one
Check for the outer box label with Catalog #20400161S/10 and ENDOFLATOR 26-430520-1. The pouches inside may show incorrect catalog numbers like 20400162S for a different product.
Brand
Karl Storz Endoscopy
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Pouch Labels
Inspect the pouches inside the cardboard box for the correct catalog number 20400161S. If labeled as 20400162S, it is part of the recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0098-2018 (October 10, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0098-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.