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 Drager Pendula spring arm device has a set of screws located on the spring arm that were not properly secured with Loctite and may become loose. |
| Product | Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required |
| Quantity | 63 |
| Distribution | Nationwide Distribution including AK, AZ, CA, CO, FL, IL, KY, MI, MO, NB, NJ, NY, OH, PA, RI, SD, TN, TX, UT, WA & WV. |
| Initiated | 2016-10-05 |
| Classified | 2016-12-12 |
| Terminated | 2017-04-14 |
| Recall number | Z-0746-2017 |
| 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-0746-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75385/
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