Ferno Model 35X Stretchers Recalled Due to Loose Wheel Assemblies
Ferno-Washington Inc is recalling 46 Model 35X stretchers because wheel castor assemblies may loosen, posing a risk of injury.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect that poses a risk of harm (injury from falling or instability), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ferno-Washington Inc is recalling 46 units of the Ferno Model 35X PROFlexx Stretchers. The recall was initiated because the wheel castor assemblies on these stretchers may be loosening.
The affected products were distributed to hospitals and healthcare facilities in Ohio, Massachusetts, Hawaii, New Jersey, Tennessee, Texas, Missouri, and Georgia, as well as to Canada, Germany, and Venezuela. Specific serial numbers for the affected units are listed in the official recall documentation.
Healthcare facilities should stop using the affected stretchers and contact Ferno-Washington Inc for instructions on how to resolve the issue. Consumers who have purchased these devices should also contact the manufacturer for guidance.
The recalled product
- Product
- Ferno Model 35X PROFlexx Stretchers, one unit per package
- Manufacturer
- Ferno-Washington Inc
- Affected units
- 46
Distribution
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