Class II — Steris Corporation
| Recalling firm | STERIS Corporation |
|---|---|
| Registered facility | Key Surgical, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature. |
| Product | AMSCO® Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications. |
| Quantity | 2,319 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Bahrain, Canada, China, Colombia, Costa Rica, France, Hong Kong, India, Indonesia, Israel, Kuwait, Lebanon, Mexico, Panama, Peru, Republic of Korea, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, Uganda, United Arab Emirates, Viet Nam & Virgin Islands. |
| Initiated | 2015-11-20 |
| Classified | 2016-01-06 |
| Terminated | 2016-10-27 |
| Recall number | Z-0603-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Steris Corporation (Z-0603-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72825/
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