FDA Device recall Z-0098-2018
STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer…
- FDA Device
- Class II
- terminated
- Published 2017-11-22
On 2017-11-22 the FDA classified a Class II recall of STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer… by Karl Storz Endoscopy, citing the label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0098-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-10 |
| Published | 2017-11-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Karl Storz Endoscopy |
| Distribution | US |
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
The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.
Identifiers
| code_info | Lot #129241 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0098-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.