Kendall SCD Express Sterile Sleeves — Class II medical device recall Z-1041-2019
Terminated recall by COVIDIEN LLC, reported 2019-04-03, distributed in CA, NJ, WA. The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoin
| Recall number | Z-1041-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | COVIDIEN LLC, Mansfield, MA, United States |
| Recall initiated | 2019-02-15 |
| Classified | 2019-03-22 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-07-24 |
| Distributed | CA, NJ, WA |
| Quantity | 25 units |
| Reason classes | labeling, sterility |
| Lot numbers | 83410S09D |
| Model numbers | 9736 |
Product
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Reason for recall
The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
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-1041-2019. 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.