Z-1081-2016Class II

Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered...

Name: Z-1081-2016 Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered...
Creator: Stryker Medical Division of Stryker Corporation
Published: 2015-12-03
License: https://open.fda.gov/license/

Stryker Medical / initiated 2015-12-03 / Terminated / root cause: design

FDA source

Stryker Medical Division of Stryker Corporation began a recall of Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL)... on 2015-12-03. FDA classified it as Class II and gives the reason as "Potential for power cord to melt; hazards include electric shock and fire". 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-1081-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-03
Posted: 2016-03-08
Terminated: 2017-05-24
Recalling firm: Stryker Medical
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.
Product code: FNM Mattress, Air Flotation, Alternating Pressure
Reason for recall: Potential for power cord to melt; hazards include electric shock and fire.
Root cause tag: design
FDA 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 in commerce: 2694
Distribution: Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Chile, France, Hong Kong, Italy, Mexico, South Korea, Switzerland, United Kingdom.
Product codes and lots: model number: 2920-000-000 units serialized

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1081-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1081-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08

Product code FNM

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)