Ferno-Washington Recalls Pediatric Traction Splint Straps Due to Labeling Error
Ferno-Washington is recalling 153 pediatric traction splint strap kits because they were shipped in adult-labeled packaging. This labeling error could lead to the use of the wrong size equipment for patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error that could lead to the use of the wrong size medical device, which is a moderate risk but does not involve immediate life-threatening injury or death.
Plain-English summary
Ferno-Washington Inc is recalling 153 units of Poly-bags containing splint straps labeled with a "Pediatric" sticker. The recall was initiated after the firm determined that its supplier had incorrectly labeled the outside packaging for pediatric and adult traction splint straps. Specifically, packaging labeled "Adult" contained pediatric splint straps, and packaging labeled "Pediatric" contained adult splint straps.
The affected product is the Strap Kit Pediatric Model 443. Each kit contains adjustable length leg straps, an ankle wrap, a thigh pad, and a heel stand, which are applied to a traction splint frame to immobilize and provide traction for a patient's leg. The incorrect labeling poses a risk that medical providers might use the wrong size of splint strap for a patient, potentially compromising the effectiveness of the immobilization or traction.
The products were distributed worldwide, including to various US states and countries such as the UAE, Malaysia, and the United Kingdom. There are no government accounts for this recall, but one Canadian account is affected. Users should check their inventory for these specific kits and contact Ferno-Washington for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.
- Manufacturer
- Ferno-Washington Inc
- Affected units
- 153
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Strap Kit Pediatric Model 443
Distribution
Part of a larger recall action
This product is one of 2 recalled by Ferno-Washington Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Ferno-Washington Inc
See all →- SevereFDA Recalls Power F2 Fastening Systems Over Rail Wear Risk
FDA (Devices) · 2026-07-29
- HighPowered ambulance cots recalled because fastening post hardware could loosen
FDA (Devices) · 2025-10-22
- HighFERNO POWER X1 ambulance cot batteries pose fire and burn risk
FDA (Devices) · 2022-11-16
- ModerateFerno Chair Cot Recalled Due to Incorrect Manufacturing Nut
FDA (Devices) · 2017-04-26
- ModerateFerno-Washington Recalls Traction Splint Straps Due to Incorrect Packaging Labels
FDA (Devices) · 2016-05-11
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- ModerateOrthoPediatrics PediLoc Locking Plate System Recalled for Incorrect Left-Right Labeling
FDA (Devices) · 2012-08-01
- ModerateStryker Recalls 18 Hinge Coupling Units Due to Packaging Error
FDA (Devices) · 2018-05-02
- ModerateOrthoPediatrics Recalls 3.5mm Locking Screws Due to Packaging Labeling Error
FDA (Devices) · 2013-11-20
- HighPERLA TL Lateral Connector Open Spinal Fusion Devices Recalled for External Label Error
FDA (Devices) · 2021-07-07
- HighFerno iNX Wheeled Stretcher Recalled for Telescoping Load Frame Defect
FDA (Devices) · 2015-10-07
- HighStapes prosthesis pistons carry an incorrect functional length on labeling
FDA (Devices) · 2026-06-10