Z-1256-2023Class II

Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency...

Name: Z-1256-2023 Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency...
Creator: Stryker Medical Division of Stryker Corporation
Published: 2023-02-01
License: https://open.fda.gov/license/

Stryker Medical / initiated 2023-02-01 / Open, Classified

FDA source

Stryker Medical Division of Stryker Corporation began a recall of Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001 on 2023-02-01. FDA classified it as Class II and gives the reason as "Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1256-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-01
Posted: 2023-03-15
Recalling firm: Stryker Medical
Product: Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
Product code: FPO Stretcher, Wheeled
Reason for recall: Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport.
FDA root cause: Under Investigation by firm
Action: Stryker issued Urgent Medical Device Correction letter dated 2/1/23. Letter states reason for recall, health risk and action to take: 1. Locate the units listed on the attached business reply form and remove them from service until repairs are complete. 2. Return the enclosed business reply form to confirm receipt of this notification by fax +1 269 488 8691 or email [email protected]. 3. Stryker will contact you to arrange for the modification/repair of your Power-PRO 2. 4. If you have loaned or sold or disposed of any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. Questions or concerns, contact Customer Service at +1 800 327 0770 Monday through Friday from 8:00 a.m. to 6:00 p.m. ET.
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in the states of NY, VA.
Product codes and lots: GTIN: 07613327559118 Serial Numbers: 2208002066, 2208002071, 2209001508, 2208001664

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1256-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1256-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-15

Product code FPO

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)