# FDA recall Z-0098-2018

> **Karl Storz Endoscopy** · Class II · device recall initiated 2017-10-10.

## 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 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.

## 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.

## Distribution

Distribution was made nationwide.  There was government distribution and no military distribution.  Foreign distribution was made to Canada.

## Key facts

- **Recall number:** Z-0098-2018
- **Recalling firm:** Karl Storz Endoscopy
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-10
- **Report date:** 2017-11-22
- **Termination date:** 2018-06-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** El Segundo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0098-2018

## Citation

> AI Analytics. FDA recall Z-0098-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0098-2018. Source: US FDA. Licensed CC0.

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