FDA Medical Device Recalls (openFDA)
Karl Storz Endoscopy: 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.
- Recall number
- Z-0098-2018
- Recalling firm
- 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), 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.
- Status
- Terminated
- Initiated
- 2017-10-10
- Posted
- not on file
- Terminated
- 2018-06-22
- 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.
- Root cause
- Labeling mix-ups
- Action
- The recalling firm issued letters flagged as 'SAFETY ALERT" dated 10/5/2017 via Federal Express on 10/10/2017.
- Quantity
- 496/10-pouch boxes
- Distribution
- Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.
- Lot, serial or model codes
- Lot #129241
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NKC
- Firm FEI
- 3007475226
- Firm city
- El Segundo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28