FDA Device recall Z-0419-2018
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets
- FDA Device
- Class II
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class II recall of MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets by Stryker Medical Division, citing it was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joule….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0419-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-21 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Medical Division |
| Distribution | n/a |
Product
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Reason
It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective side toward the patient (upside down).
Identifiers
| code_info | LOT #(s): 1640002, 1645003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0419-2018%22
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