Hercules 360 Universal Stabilizing Arm — Class II medical device recall Z-1201-2017
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2017-02-22. Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing
| Recall number | Z-1201-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Elkton, MD, United States |
| Recall initiated | 2014-08-20 |
| Classified | 2017-02-14 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2017-02-15 |
| Quantity | 260 |
Product
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Reason for recall
Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing Arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleeve to separate from the device. While the arm can still function without the pins and sleeve in place, there is potential for the loose components to fall into the surgical site.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1201-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.