Steris Olympus Leak Test Adapter Recalled for Cleaning Solution Intrusion Risk
Steris Corporation is recalling Olympus Leak Test Adapters used with Acu-sInQ systems due to a potential for cleaning solution to intrude into endoscopes.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2.
Plain-English summary
Steris Corporation is recalling the Olympus Leak Test Adapter (Part number: 0600818OKN), which is used with Acu-sInQ Complete Endoscope Cleaning Aid Systems to assist in manual flexible endoscope cleaning. The recall is due to a potential for cleaning solution to intrude into the endoscope.
A total of 293 units are affected, with 248 units distributed in the United States and 45 units distributed outside the U.S. The products were distributed nationwide and in Canada, Italy, Kuwait, the United Kingdom, and the United Arab Emirates. Distribution occurred from May 23, 2017, to June 30, 2020.
The U.S. Food and Drug Administration has classified this recall as Class III. Users should contact Steris Corporation for further instructions regarding the return or replacement of the affected adapters.
The recalled product
- Product
- Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
- Manufacturer
- Steris Corporation
- Hazard
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 (3)
- Distributed from May 23
- 2017 to June 30
- 2020
Distribution
Distributed nationwide across the United States.
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