Steris ATLAS Loading Car Recalled for Latch Failure Risk
Steris Corporation is recalling 129 ATLAS Loading Cars because the latch may fail to engage when empty, causing the unit to slide or fall.
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 physical harm (sliding or falling), but no injuries or illnesses have been reported in the source text.
Plain-English summary
Steris Corporation is recalling 129 units of the ATLAS Loading Car. The recall is due to a defect where the loading car may not remain fully engaged with the latch on the transfer carriage when the car is empty.
This defect potentially results in the loading car unexpectedly sliding forward or falling to one side. The affected units were distributed domestically across the United States and internationally to Canada, Costa Rica, Indonesia, South Korea, and Taiwan.
Healthcare facilities and users should stop using the affected ATLAS Loading Cars and contact Steris Corporation for instructions on the recall. Specific lot codes for the affected units are listed in the official FDA recall record Z-0824-2019.
The recalled product
- Product
- ATLAS Loading Car
- Manufacturer
- Steris Corporation
- Affected units
- 129
Distribution
Distributed nationwide across the United States.
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