Z-0260-05

XPRT Therapy Mattress Systems: Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover)...

Name: Z-0260-05 XPRT Therapy Mattress Systems: Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover)...
Creator: Gaymar Industries Inc
Published: 2004-10-25
License: https://open.fda.gov/license/

Gaymar Industries, Inc. / initiated 2004-10-25 / Terminated / root cause: design

FDA source

Gaymar Industries Inc began a recall of XPRT Therapy Mattress Systems: Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without... on 2004-10-25. The reason FDA records is "Design control/validation deficiencies". 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-0260-05
Status: Terminated
Initiated: 2004-10-25
Posted: 2004-11-30
Terminated: 2006-02-08
Recalling firm: Gaymar Industries, Inc.
Product: XPRT Therapy Mattress Systems: Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without coating (standard cover). Responsible firm on the label: Manufactured for STRYKER MEDICAL, 6300 South Sprinkle Road, Kalamazoo, MI USA 49001-9799, 1-800-327-0770. The unit consists of a sleep surface, an integrated valve box located in the head of the mattress, a pump box located under the foot of the mattress and a color touch screen controller that can be mounted to either side of the pump box at the foot end of the mattress.
Product code: IKZ Bed, Patient Rotation, Powered
Reason for recall: Design control/validation deficiencies.
Root cause tag: design
FDA root cause: Other
Action: Letter dated 10/25/2004 to Stryker Medical, own-label distributor, with instructions to remove patients from the system and return units to Gaymar.
Quantity in commerce: 48 units
Distribution: The units were sold to the own-label distributor, who in turn sold 8 units to two hospitals in Nebraska and Hawaii.
Product codes and lots: The following serial numbers, which represent all units shipped: H40001 thru H40038; and I40001, I40003, I40004, I40005, I40006, I40009, I40012, I40013, I40014, I40017, I40018, and I40021.

Product code IKZ

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)