Z-1942-2020Class III

Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10...

Name: Z-1942-2020 Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10...
Creator: Karl Storz Endoscopy
Published: 2019-01-09
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2019-01-09 / Terminated / root cause: supplier

FDA source

Karl Storz Endoscopy began a recall of Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10 on 2019-01-09. FDA classified it as Class III and gives the reason as "The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1942-2020
Classification: Class III
Status: Terminated
Initiated: 2019-01-09
Posted: 2020-05-09
Terminated: 2022-09-28
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Product code: NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic
Reason for recall: The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: The recalling firm sent an URGENT SAFETY NOTICE OF PRODUCT RECALL (via FedEx) to the impacted customers on 01/09/20120, along with acknowledgement confirmation for customer to sign and return it to the firm.
Quantity in commerce: 543 boxes were distributed; 10 ea per box.
Distribution: 57 consignees in the US. AL,AZ,CA,CT,DE,FL,GA,IL,LA,MA,MD,ME,MI,MN,NE,NH,NJ,NY,OH,OK,PA,SC,TX,VA,VT,WA and WI
Product codes and lots: Model/Lot Number: 031200-10/Lot W-027781, W-029058, W-028738; 031322-10/ Lot W-027197, W-028171, W-027939, W-028207; 031532-10/ Lot W-026437, W-027332, W-026871; 031622-10/Lot W-029555

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1942-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1942-2020	Class III	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-08

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)