FDA Medical Device Recalls (openFDA)
Stryker Sustainability Solutions: HoverMatt, 39" W x 78" L, REF: HM39SPU-B
- Recall number
- Z-2394-2023
- Recalling firm
- Stryker Sustainability Solutions
- Product
- HoverMatt, 39" W x 78" L, REF: HM39SPU-B
- Status
- Open, Classified
- Initiated
- 2023-06-21
- Posted
- 2023-08-11
- Terminated
- not on file
- Reason
- 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
- 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 SSSPFA@stryker.com 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
- 340
- Distribution
- US: WI, ID, CA, FL, HI, MD, RI, AZ, MA, GA, IL
- Lot, serial or model codes
- UDI-DI: 07613327487718, Lot: 0000185127, Distribution Dates: 11/28/2022-12/08/2022
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRZ
- Firm FEI
- 3009350690
- Firm city
- Tempe
- Firm state
- AZ
- 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