Steris Reliance Endoscope Processing System Recalled for Air Pipe Defect
Steris is recalling 266 Reliance Endoscope Processing Systems because an air pipe defect prevents forced flow during the disinfection cycle.
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 involves a defect that prevents proper forced flow during the disinfection cycle of semi-critical medical devices, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Steris Corporation is recalling 266 units of the Reliance Endoscope Processing System (REPS). The recall affects specific model numbers and serial numbers distributed nationwide in the United States and in Australia, Canada, and Spain.
The recall is due to a defect in the air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on listed Fujinon G5 and G8 type flexible GI endoscopes. The air pipe does not connect to the main air/water channel within the light guide connection head, which means the air pipe does not receive forced flow during the Reliance EPS processing cycle.
Healthcare facilities and users of the affected equipment should contact Steris Corporation for instructions on how to resolve the issue.
The recalled product
- Product
- Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant…
- Manufacturer
- Steris Corporation
- Affected units
- 266
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Model #'s: MB30001
- MB30002
- MB30003
- MB000077
- MB000078
- MB000079
- MB000080 and MB000081. Serial number range 3625606001 - 3608912002
Distribution
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