Stryker Power-PRO TL Ambulance Cots Recalled for Crash Test Non-Compliance
Stryker is recalling 34 Power-PRO TL ambulance cots in the UK because they may not meet the crash test standard BS EN 1789.
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, and the hazard involves a structural defect (failure to meet crash test standards) in a medical device used for patient transport, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 34 units of the Power-PRO TL cot-powered ambulance cot, Model Number 6550. These powered wheeled stretchers are intended to support and transport the entire body of a traumatized, ambulatory, or non-ambulatory human patient, including infants and adults.
The recall was initiated because the affected ambulance cots may not meet the crash test standard BS EN 1789. The distribution pattern for this recall is limited to the United Kingdom.
Affected units are identified by specific serial numbers listed in the recall documentation. Consumers and healthcare providers should verify the serial numbers of their devices against the recall list and contact Stryker for further instructions.
The recalled product
- Product
- Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device — Ambulance Cot
- Affected units
- 34
Distribution
Distribution scope not specified by the agency.
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