Z-2394-2023Class II

HoverMatt, 39" W x 78" L, REF: HM39SPU-B

Name: Z-2394-2023 HoverMatt, 39" W x 78" L, REF: HM39SPU-B
Creator: Stryker Sustainability Solutions
Published: 2023-06-21
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2023-06-21 / Open, Classified / root cause: packaging

FDA source

Stryker Sustainability Solutions began a recall of HoverMatt, 39" W x 78" L, REF: HM39SPU-B on 2023-06-21. FDA classified it as Class II and gives the reason as "39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the patient's weight across, which may increase the effort...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2394-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-21
Posted: 2023-08-11
Recalling firm: Stryker Sustainability Solutions
Product: HoverMatt, 39" W x 78" L, REF: HM39SPU-B
Product code: FRZ Device, Patient Transfer, Powered
Reason for recall: 39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the patient's weight across, which may increase the effort exerted by staff for a lateral patient transfer, and there may be increased friction and shearing forces when the patient is moved resulting in skin tear injury.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On 6/21/23, recall notices were distributed to customers who were asked to do the following: 1) Return affected devices. 2) Complete and return the Business Reply form to [email protected] 3) If any of the affected product have been forwarded to additional facilities (including but not limited to distribution warehouses), contact these facilities and communicate this recall to them and instruct them to complete and return the Business Reply Form. Adverse reactions or quality problems can be reported to the Complaint Hotline: +1-888-763-8803 or http://www.stryker.com/productexperience
Quantity in commerce: 340
Distribution: US: WI, ID, CA, FL, HI, MD, RI, AZ, MA, GA, IL
Product codes and lots: UDI-DI: 07613327487718, Lot: 0000185127, Distribution Dates: 11/28/2022-12/08/2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2394-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2394-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-10

Product code FRZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)