FDA Medical Device Recalls (openFDA)
Stryker Medical Division of Stryker Corporation: MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
- Recall number
- Z-0419-2018
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Product
- MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
- Status
- Terminated
- Initiated
- 2017-07-21
- Posted
- not on file
- Terminated
- 2018-03-22
- 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).
- Root cause
- Component design/selection
- Action
- Stryker notified customers of the recall by sending Customer Notification and Business Reply Forms, dated July 21, 2017.
- Quantity
- 11160
- Distribution
- U.S.
- Lot, serial or model codes
- LOT #(s): 1640002, 1645003
- 510(k) numbers
- ["K101705"]
- PMA numbers
- not on file
- Product code
- DWJ
- Firm FEI
- 1831750
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28