FDA Device recall Z-1942-2020
Insufflation tubing to be used with varies insufflator units
- FDA Device
- Class III
- terminated
- Published 2020-05-20
On 2020-05-20 the FDA classified a Class III recall of Insufflation tubing to be used with varies insufflator units by Karl Storz Endoscopy, citing the sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1942-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-01-09 |
| Published | 2020-05-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Karl Storz Endoscopy |
| Distribution | 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, WI |
Product
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Reason
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
Identifiers
| code_info | Model/Lot Number: 031200-10/Lot W-027781, W-029058, W-028738; 031322-10/ Lot W-027197, W-028171, W-027939, W-02820…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1942-2020%22
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