Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 22, 2017
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
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…
Terumo Cardiovascular Systems Corporation recalled Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainles… - a moderate-severity action.
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainles… was recalled by Terumo Cardiovascular Systems Corporation in February 22, 2017. Reason: Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing…. Check the official notice for the remedy. Verify recall #Z-1201-2017 with the FDA Devices before acting.
The recall
Terumo Cardiovascular Systems Corporation issued this moderate-severity FDA Devices recall-Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing….
- Moderate
- severity level
- Class II
- classification
- February 22, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1201-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1201-2017) was formally reported on February 22, 2017, with the manufacturer initiating the action on August 20, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Terumo Cardiovascular Systems Corporation is listed as the recalling firm, operating out of Elkton, MD. Federal records list the affected scope as The total number of distributed devices stands at 260.
The documented reason for this recall is: 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, causi… Distribution data in the federal record shows the product reached: Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .. 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
The total number of distributed devices stands at 260
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1201-2017 |
| Date reported | February 22, 2017 |
| Date initiated | August 20, 2014 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Firm location | Elkton, MD |
| Affected scope | The total number of distributed devices stands at 260 |
| Distribution | Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees . |
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-1201-2017) 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? ▼
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: The total number of distributed devices stands at 260.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 22, 2017. Severity: Moderate. Recall number: Z-1201-2017.
Where was the recalled product distributed? ▼
Distribution: Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees ..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1201-2017) 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 February 22, 2017. 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.