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FDA Medical Device Recalls (openFDA)

Ferno-Washington Inc: Ferno Model 35X PROFlexx Stretchers, one unit per package

Recall number
Z-0995-2015
Recalling firm
Ferno-Washington Inc
Product
Ferno Model 35X PROFlexx Stretchers, one unit per package
Status
Terminated
Initiated
2014-12-03
Posted
2015-01-16
Terminated
2015-12-01
Reason
The wheel castor assemblies may be loosening on the stretchers.
Root cause
Mixed-up of materials/components
Action
Ferno initiated contact with customers via email and telephone on Wednesday, December 3, 2014. The firm will replace all wheel caster assemblies.
Quantity
46 units
Distribution
The affected product was distributed to the following states: OH, MA, HI, NJ, TN, TX, MO, and GA. The affected product was distributed to the following foreign countries: Canada, Germany and Venezuela.
Lot, serial or model codes
The following serial numbers are affected by this recall: 13N272700 13N273357 13N273915 13N274967 13N275720 13N272701 13N273358 13N273916 13N274968 13N275721 13N272702 13N273359 13N273917 13N274969 13N275722 13N272703 13N273360 13N274387 13N274970 13N275723 13N272704 13N273361 13N274388 13N274971 13N275724 13N272705 13N273362 13N274389 13N274972 13N275725 13N273353 13N273363 13N274390 13N274973 13N275726 13N273354 13N273902 13N274391 13N275717 13N273355 13N273913 13N274965 13N275718 13N273356 13N273914 13N274966 13N275719
510(k) numbers
not on file
PMA numbers
not on file
Product code
FPO
Firm FEI
1523574
Firm city
Wilmington
Firm state
OH
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

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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

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