Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 18, 2018
Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product 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, theatre shoes and other miscellaneous reusable items used in the care of patients.
The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level alarm, intended to prevent the user from initiating a cycle when a low …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Steris Corporation recalled Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product … - a moderate-severity action.
Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product … was recalled by Steris Corporation in July 18, 2018. Reason: The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level a…. Check the official notice for the remedy. Verify recall #Z-2392-2018 with the FDA Devices before acting.
The recall
Steris Corporation issued this moderate-severity FDA Devices recall-The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level a….
- Moderate
- severity level
- 118 units
- affected scope
- Class II
- classification
- July 18, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2392-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2392-2018) was formally reported on July 18, 2018, with the manufacturer initiating the action on May 23, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Steris Corporation is listed as the recalling firm, operating out of Mentor, OH. Federal records list the affected scope as 118.
The documented reason for this recall is: The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level alarm, intended to prevent the user from initiating a cycle when a low chemical level situation occurs, does no… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of AL, AK, CA, CO, CN, DE, FL, GA, IL, IA, KS, KY, LA, MA, MI, NJ, NY, ND, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WI, and WV. Foreign distribution to Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
118
Related Recalls
6
3 from same agency
Product description
Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product 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, theatre shoes and other miscellaneous reusable items used in the care of patients.
Reason for recall
The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level alarm, intended to prevent the user from initiating a cycle when a low chemical level situation occurs, does not operate as intended. Currently, if a low chemical level situation occurs, the alarm will only be generated at the unit s next power-up or when accessing service mode. The failure of the Reliance 1227 to identify that the chemicals used for cleaning are low or empty could result in bedpans and urinals, basins, case carts, beds, theater shoes and other miscellaneous reusable patient care items not being properly cleaned before disinfection or reuse.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2392-2018 |
| Date reported | July 18, 2018 |
| Date initiated | May 23, 2018 |
| Recalling firm | Steris Corporation |
| Firm location | Mentor, OH |
| Affected scope | 118 |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, AK, CA, CO, CN, DE, FL, GA, IL, IA, KS, KY, LA, MA, MI, NJ, NY, ND, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WI, and WV. Foreign distribution to Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2392-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product 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, theatre shoes and other miscellaneous reusable items used in the care of patients.. Recalled by Steris Corporation. Units affected: 118.
Why was this product recalled? ▼
The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level alarm, intended to prevent the user from initiating a cycle when a low chemical level situation occurs, does not operate as intended. Currently, if a low chemical level situation occurs, the alarm will only be generated at the unit s next power-up or when accessing service mode. The failure of the Reliance 1227 to identify that the chemicals used for cleaning are low or empty could result in bedpans and urinals, basins, case carts, beds, theater shoes and other miscellaneous reusable patient care items not being properly cleaned before disinfection or reuse.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 18, 2018. Severity: Moderate. Recall number: Z-2392-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide in the states of AL, AK, CA, CO, CN, DE, FL, GA, IL, IA, KS, KY, LA, MA, MI, NJ, NY, ND, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WI, and WV. Foreign distribution to Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2392-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 18, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.