Skip to the content

FDA Medical Device Recalls (openFDA)

Stryker Medical Division of Stryker Corporation: Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated control unit to provide changes in the distribution of body weight for pressure relief. PositionPRO offers turn assist. PositionPRO is for use with GoBed II, Secure II/3, InTouch, and Epic II 84 in. x 35 in. flat deck frames. This surface is powered via an AC power cord that comes in either a 4 foot long option (PN QDF8087) or 15 foot long option (PN QDF8088). The 4 foot long option is used when the surface is plugged into the auxiliary outlet of the bed. The 15 foot long option is utilized when the surface needs to be plugged into a wall outlet. This product uses a power cord, manufactured by ElectriCord that plugs into the wall outlet or the auxiliary outlet of the bed that the surface is placed onto.

Recall number
Z-1081-2016
Recalling firm
Stryker Medical Division of Stryker Corporation
Product
Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated control unit to provide changes in the distribution of body weight for pressure relief. PositionPRO offers turn assist. PositionPRO is for use with GoBed II, Secure II/3, InTouch, and Epic II 84 in. x 35 in. flat deck frames. This surface is powered via an AC power cord that comes in either a 4 foot long option (PN QDF8087) or 15 foot long option (PN QDF8088). The 4 foot long option is used when the surface is plugged into the auxiliary outlet of the bed. The 15 foot long option is utilized when the surface needs to be plugged into a wall outlet. This product uses a power cord, manufactured by ElectriCord that plugs into the wall outlet or the auxiliary outlet of the bed that the surface is placed onto.
Status
Terminated
Initiated
2015-12-03
Posted
2016-03-08
Terminated
2017-05-24
Reason
Potential for power cord to melt; hazards include electric shock and fire.
Root cause
Component design/selection
Action
Stryker sent an URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letter dated November 10, 2015 to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any urgent questions or concerns, please, contact Stryker Customer Service at (1-800-327-0770). Normal business hours are Monday-Friday 8 a.m-5 p.m. (ET).
Quantity
2694
Distribution
Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Chile, France, Hong Kong, Italy, Mexico, South Korea, Switzerland, United Kingdom.
Lot, serial or model codes
model number: 2920-000-000 units serialized
510(k) numbers
not on file
PMA numbers
not on file
Product code
FNM
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

Search this register