HoverMatt, 39" W x 78" L, REF: HM39SPU-B recallZ-2394-2023 · Stryker Sustainability Solutions · initiated Jun 21, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Sustainability Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Packaging process control
What the company is doing
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
Recall details
- Recall number
- Z-2394-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 21, 2023
- Posted by the FDA
- Aug 11, 2023
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 340
- Product code
- FRZ
- Distribution
- US: WI, ID, CA, FL, HI, MD, RI, AZ, MA, GA, IL
Product description
HoverMatt, 39" W x 78" L, REF: HM39SPU-B
Code information (models, lots, serial numbers)
UDI-DI: 07613327487718, Lot: 0000185127, Distribution Dates: 11/28/2022-12/08/2022
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- N/A HM39SPU-BStryker Sustainability Solutions, Inc. · DEVICE, PATIENT TRANSFER, POWERED1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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