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 | Ongoing |
| Reason | Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems |
| Product | Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319 |
| Quantity | BIS 46,961; Spare Batteries: 6,937 |
| Distribution | Nationwide Foreign: Australia, New Zealand |
| Initiated | 2018-07-26 |
| Classified | 2018-08-30 |
| Recall number | Z-2958-2018 |
| 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-2958-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80804/
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