Insufflation tubing to be used with varies insufflator units — Class III medical device recall Z-1942-2020
Terminated recall by Karl Storz Endoscopy, reported 2020-05-20, distributed in AL, AZ, CA, CT, DE, FL, GA, IL…. The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
| Recall number | Z-1942-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Karl Storz Endoscopy, El Segundo, CA, United States |
| Recall initiated | 2019-01-09 |
| Classified | 2020-05-08 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2022-09-28 |
| Distributed | 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 |
| Reason classes | chemical contamination, sterility |
| Lot numbers | 031200-10, 031322-10, 031532-10, 031622-10, W-026437, W-026871, W-027197, W-027332, W-027781, W-027939, W-028171, W-028207, W-028738, W-029058, W-029555 |
| Model numbers | 031200-10, 031322-10, 031532-10, 031622-10 |
Product
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Reason for recall
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1942-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.