Karl Storz Endoscopy: Medical Device Recall in 2020 - (Recall #: Z-1942-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.
Product Description:

Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10

Product Classification:

Class III

Date Initiated: January 9, 2019
Date Posted: May 20, 2020
Recall Number: Z-1942-2020
Event ID: 85388
Reason for Recall:

The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.

Status: Terminated
Product Quantity: 543 boxes were distributed; 10 ea per box.
Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated