Class II — COVIDIEN LLC
| Recalling firm | Covidien llc |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution. |
| Product | Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736 |
| Quantity | 25 units |
| Distribution | The products were distributed to the following US states: CA, NJ, and WA. |
| Initiated | 2019-02-15 |
| Classified | 2019-03-22 |
| Terminated | 2020-07-24 |
| Recall number | Z-1041-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — COVIDIEN LLC (Z-1041-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82245/
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