Z-2465-2008

Ferno Model 35X PROFlexX Ambulance Stretcher, Model #'s: 35X; 35XST; 35XIT. The Ferno Model 35-X PROFlexx...

Name: Z-2465-2008 Ferno Model 35X PROFlexX Ambulance Stretcher, Model #'s: 35X; 35XST; 35XIT. The Ferno Model 35-X PROFlexx...
Creator: Ferno-Washington Inc
Published: 2008-09-03
License: https://open.fda.gov/license/

Ferno-Washington Inc / initiated 2008-09-03 / Terminated / root cause: design

FDA source

Ferno-Washington Inc began a recall of Ferno Model 35X PROFlexX Ambulance Stretcher, Model #'s: 35X; 35XST; 35XIT. The Ferno Model 35-X PROFlexx ambulance stretcher is used to transport a patient... on 2008-09-03. The reason FDA records is "The Ferno Model 35-X PROFlexx legs could experience metal fatigue and possibly fracture after one to two years of use based on the usage and method of operation". 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-2465-2008
Status: Terminated
Initiated: 2008-09-03
Posted: 2008-09-30
Terminated: 2012-09-27
Recalling firm: Ferno-Washington Inc
Product: Ferno Model 35X PROFlexX Ambulance Stretcher, Model #'s: 35X; 35XST; 35XIT. The Ferno Model 35-X PROFlexx ambulance stretcher is used to transport a patient during rescue or emergency situations as well as a means to transport patients for general medical purposes.
Product code: FPO Stretcher, Wheeled
Reason for recall: The Ferno Model 35-X PROFlexx legs could experience metal fatigue and possibly fracture after one to two years of use based on the usage and method of operation.
Root cause tag: design
FDA root cause: Device Design
Action: On 9-03-2008 the firm sent via certified mail Urgent Voluntary Correction letters to their customers instructing them to immediately inspect the stretcher according to the 35X PROFlexx Leg Inspections instruction sheet. Customers are to also telephone the firm upon completion of the inspection to arrange for a replacement kit. Contact Ferno Technical Support at 1-866-987-3776 for assistance.
Quantity in commerce: 2,100
Distribution: Worldwide Distribution --- USA including states of AK, AL, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NM, NY,OH, OK, PA, SC, TN, TX, VA, WI, and WV, and countries of Austria, China, Egypt, Germany, Hong Kong, Japan, Lebanon, Mexico, Poland, United Kingdom, and South Africa.
Product codes and lots: Serial Numbers Range between 06-002156 and 07-054091.

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)