FDA Medical Device Recalls (openFDA)
Karl Storz Endoscopy: Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
- Recall number
- Z-1942-2020
- Recalling firm
- Karl Storz Endoscopy
- Product
- Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
- Status
- Terminated
- Initiated
- 2019-01-09
- Posted
- not on file
- Terminated
- 2022-09-28
- Reason
- The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
- 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
- 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
- Lot, serial or model codes
- 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
- 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