The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1350-2019·Announced 2019-05-22

Stryker Power-LOAD Cot Fastening System Recalled for Broken Floor Plates

Stryker is recalling 3,285 Power-LOAD Cot Fastening Systems because the floor plates holding ambulance cot anchors may be broken.

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 is classified as FDA Class II. The hazard involves a structural failure of a medical device used for patient transport, which presents a risk of harm, but the source text does not report any specific injuries or fatalities.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling 3,285 units of the Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000. The recall is due to a defect where the power load floor plates, which hold the ambulance cot anchors in place during patient transport, may be broken.

The affected units were distributed nationwide in the United States and in Australia, Canada, the Netherlands, South Africa, and Switzerland. The source text does not specify the number of reported injuries or illnesses associated with this defect.

Healthcare facilities and users should check their inventory for the affected model and catalog numbers. If the product is found, it should be removed from service and returned to Stryker or the authorized distributor for inspection or replacement, per the recall instructions.

The recalled product

Product
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
Affected units
3,285

Distribution

Distributed nationwide across the United States.

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