Ferno-Washington Inc
FDA Regulatory Profile
Ferno-Washington Inc appears in FDA public data with 8 recalls, 5 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0133-2026, Class II) was initiated on September 11, 2025. Its most recent 510(k) clearance was granted on April 21, 1998.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 5
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0133-2026 | Class II | FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATIO | September 11, 2025 |
| Z-0184-2023 | Class II | FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model | October 7, 2022 |
| Z-1827-2017 | Class II | Ferno PROFlexx¿ Model 28Z Chair Cot | March 8, 2017 |
| Z-1604-2016 | Class II | Poly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains adjustable l | March 10, 2016 |
| Z-1603-2016 | Class II | Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjus | March 10, 2016 |
| Z-2826-2015 | Class II | Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System Product Usage: Stretc | August 3, 2015 |
| Z-2461-2015 | Class II | Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospita | May 1, 2015 |
| Z-0995-2015 | Class II | Ferno Model 35X PROFlexx Stretchers, one unit per package | December 3, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K980033 | FERNO HEALTHCARE RECLINE-A-BATH 2 | April 21, 1998 |
| K932417 | FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT | September 9, 1993 |
| K864765 | MODEL 668, TRACTION SPLINT, ADULT | December 17, 1986 |
| K864269 | MODEL 35-B ALL LEVEL COT | November 13, 1986 |
| K862441 | EZ LOAD MODEL 30, ALL LEVEL COT | September 12, 1986 |