FDA Device recall Z-2958-2018
Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
- FDA Device
- Class II
- ongoing
- Published 2018-09-05
On 2018-09-05 the FDA classified a Class II recall of Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems by Covidien, citing revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2958-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-07-26 |
| Published | 2018-09-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien |
| Distribution | US |
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
Reason
Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
Identifiers
| code_info | Batteries with date code 3114 or older (Week 31 of 2014) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2958-2018%22
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