Facility
FERNO-WASHINGTON, INC.
8 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 1523574 |
|---|---|
| Establishment type | Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | 70 WEIL WAY Wilmington, OH, US 45177 |
| Registration status | Active · expires 2026 |
| Parent company | Ferno-Washington, Inc. (owner-operator 10025359) |
| Brand names | Model 414 Restraint series (414-OL, 414-R); Model 410R Restraint Retractor; Model 439 Restraints; Pedi-Mate Restraint series (PediMate, PediMate Plus); Kwik Klip Restraints; Model 417 Restraint series (417, 417-1); Model 436 Restraint series (436, 436i); Model 415 Restraint; Restraint Extenders; Model 770 Fastrap; Model 430 Restraint series (430, 430P); NeoMate Restraint |
Devices registered here (1)
- Stretcher, Patient RestraintProduct code NZD · Class I · General Hospital · 21 CFR 880.6900
Recalls & enforcement
- Class IIOngoing2026-06-19Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible
- Class IIOngoing2025-09-11The fastening post hardware could loosen allowing the fastening post to detach from the cot
- Class IIOngoing2022-10-07Batteries could become unstable when not properly maintained and/or subjected to repeated drops, power washing directly into battery contacts or abuse, may result in a fire and/or injury
- Class IITerminated2017-03-08The recall was initiated as a result of the detection of an incorrect nut used in manufacturing.
- Class IITerminated2016-03-10On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. The firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps
- Class IITerminated2015-08-03Hole elongation in the telescoping load frame channel. A hole elongation could affect the ability of the retention pin to stay seated which is necessary to preclude movement of the telescoping load frame.
- Class IITerminated2015-05-01The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. The screw assists in preventing the bearing cup on the caster assembly from backing out of the caster arm during use.
- Class IITerminated2014-12-03The wheel castor assemblies may be loosening on the stretchers.
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
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