Food, drugs, devices › Steris Corporation
Device recall: Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinf
Steris Corporation (Mentor, OH) initiated this device recall on 30 Jun 2014; FDA lists 1 product record under event 68696, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 1 Jul 2015. Initiation: voluntary: firm initiated. Steris Corporation has 58 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Steris Corporation, Mentor, OH.
Reason for recall
"STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Should deformation and/or breakage of the door handle pin occur there is a potential for the washer door to become inoperable."
Distribution
"US Nationwide Distribution - in the states of AL, AR, CA, DE, FL, GA, IL, IA, LA, MA, MI, NJ, NY, OH, OK, OR, SC, TX, VA. and in the country of Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2036-2014 | Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous reusable items used in the care of patients. | 37 | Class III | Terminated | 16 Jul 2014 |
Context
Other enforcement events for Steris Corporation
All 58 events for Steris Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Should deformation and/or breakage of the door handle pin occur there is a potential for the washer door to become inoperable."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution - in the states of AL, AR, CA, DE, FL, GA, IL, IA, LA, MA, MI, NJ, NY, OH, OK, OR, SC, TX, VA. and in the country of Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Jul 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.