MA3320-PM Premium Adult — Class II medical device recall Z-0419-2018
Terminated recall by Stryker Medical Division of Stryker Corporation, reported 2018-02-07. It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defi
| Recall number | Z-0419-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Medical Division of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2017-07-21 |
| Classified | 2018-01-27 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2018-03-22 |
| Quantity | 11,160 |
| Lot numbers | 1640002, 1645003, MA3320-PM |
| Model numbers | MA3302-PM |
Product
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Reason for recall
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).
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-0419-2018. 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.