Ferno-Washington Inc

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
5
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0133-2026Class IIFERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATIOSeptember 11, 2025
Z-0184-2023Class IIFERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model October 7, 2022
Z-1827-2017Class IIFerno PROFlexx¿ Model 28Z Chair CotMarch 8, 2017
Z-1604-2016Class IIPoly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains adjustable lMarch 10, 2016
Z-1603-2016Class IIPoly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjusMarch 10, 2016
Z-2826-2015Class IIFerno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System Product Usage: StretcAugust 3, 2015
Z-2461-2015Class IIWheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospitaMay 1, 2015
Z-0995-2015Class IIFerno Model 35X PROFlexx Stretchers, one unit per packageDecember 3, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K980033FERNO HEALTHCARE RECLINE-A-BATH 2April 21, 1998
K932417FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-ITSeptember 9, 1993
K864765MODEL 668, TRACTION SPLINT, ADULTDecember 17, 1986
K864269MODEL 35-B ALL LEVEL COTNovember 13, 1986
K862441EZ LOAD MODEL 30, ALL LEVEL COTSeptember 12, 1986