STORZ High Flow Insufflation Tubing — Class II medical device recall Z-0098-2018
Terminated recall by Karl Storz Endoscopy, reported 2017-11-22, distributed nationwide. The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were misl
| Recall number | Z-0098-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Karl Storz Endoscopy, El Segundo, CA, United States |
| Recall initiated | 2017-10-10 |
| Classified | 2017-11-16 |
| Reported by FDA | 2017-11-22 |
| Terminated | 2018-06-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | labeling |
| Lot numbers | 129241 |
| Model numbers | 20400161S, 20400161S/10, 20400162S |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0098-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.