Karl Storz Recalls Mislabeled High Flow Insufflation Tubing Pouches
Karl Storz Endoscopy is recalling 496 boxes of High Flow Insufflation Tubing because some inner pouches are mislabeled with the wrong catalog number.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error where inner pouches are mislabeled as a different product. This fits the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Karl Storz Endoscopy is recalling 496 boxes of STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10. The recall involves Lot #129241. The product is individually packaged in sterile pouches, with 10 pouches per cardboard box.
The recall was initiated because the label outside the cardboard box is correct, but the pouches inside some of the boxes were mislabeled as a different product. Specifically, some pouches 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.
Distribution was made nationwide, including government distribution, and to Canada. There was no military distribution. Users should stop using the affected product and contact Karl Storz Endoscopy for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscopy
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #129241
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Karl Storz Endoscopy
See all →- LowKarl Storz Recalls HOPKINS Telescope Eyepieces Due to Labeling Error
FDA (Devices) · 2026-10-07
- HighFlexible Hystero-Fiberscope Kits Recalled Due to Expired Sterile Seals
FDA (Devices) · 2026-07-29
- HighKarl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Pediatric Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
Similar recalls
- ModerateKarl Storz Endoscopy Recalls Insufflation Tubing Due to Ethylene Oxide Residues
FDA (Devices) · 2020-05-20
- ModerateKarl Storz Irrigation Tubing Recalled for Unapproved Label Use
FDA (Devices) · 2024-11-20
- HighHigh Flow Insufflation Tubing Recalled for Incomplete Seals
FDA (Devices) · 2024-07-24
- HighKarl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions
FDA (Devices) · 2020-09-02
- ModerateKarl Storz Recalls Flexible Intubation Fiberscopes Due to Material Issue
FDA (Devices) · 2013-12-25
- HighKarl Storz Flexible Intubation Fiberscope Recall for Sterilization Instructions
FDA (Devices) · 2020-09-02