Steris Evolution Loading Car and Transfer Carriage Recall for Locking Pin Defect
Steris Corporation is recalling 237 Evolution Loading Cars and Transfer Carriages because a locking pin defect may cause the equipment to fall forward unexpectedly.
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 risk-of-harm product (medical device) where the defect could cause injury, but no injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Steris Corporation is recalling 237 units of the Evolution Loading Car and Transfer Carriage, an accessory to the Steam Sterilizer. The recall is due to a defect in the locking pin of the front wheel assembly, which may not remain fully engaged with the transfer carriage. This failure could result in the transfer carriage and loading car unexpectedly falling forward.
The affected units were distributed nationwide and in Canada, Peru, Mexico, Brazil, Saudi Arabia, and Colombia. The specific serial numbers for the recalled units are listed in the official FDA recall record Z-0586-2020.
Users of these medical devices should check their serial numbers against the provided list. If a unit is affected, they should contact Steris Corporation for instructions on how to proceed with the recall and corrective actions.
The recalled product
- Product
- Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
- Manufacturer
- Steris Corporation
- Affected units
- 237
Distribution
Distributed nationwide across the United States.
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