Z-0098-2018Class II

STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR...

Name: Z-0098-2018 STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR...
Creator: Karl Storz Endoscopy
Published: 2017-10-10
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2017-10-10 / Terminated / root cause: labeling and UDI

FDA source

Karl Storz Endoscopy began a recall of STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually... on 2017-10-10. FDA classified it as Class II and gives the reason as "The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0098-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-10
Posted: 2017-11-16
Terminated: 2018-06-22
Recalling firm: Karl Storz Endoscopy-America, Inc.
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.
Product code: NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 496/10-pouch boxes
Distribution: Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.
Product codes and lots: Lot #129241

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0098-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0098-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-22	2017-11-16

Product code NKC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)