Z-0419-2018Class II

MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM

Name: Z-0419-2018 MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Creator: Stryker Medical Division of Stryker Corporation
Published: 2017-07-21
License: https://open.fda.gov/license/

Stryker Medical / initiated 2017-07-21 / Terminated / root cause: design

FDA source

Stryker Medical Division of Stryker Corporation began a recall of MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM on 2017-07-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0419-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-21
Posted: 2018-01-27
Terminated: 2018-03-22
Recalling firm: Stryker Medical
Product: MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Product code: DWJ System, Thermal Regulating
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).
Root cause tag: design
FDA 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 in commerce: 11160
Distribution: U.S.
Product codes and lots: LOT #(s): 1640002, 1645003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0419-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0419-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-27

Product code DWJ

K101705Class IIMistral-Air Warming SystemThe Surgical Company International B.V. / cleared 2010-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)