Severity
Moderate
ModerateClass IICompleted
FDA Devices recall · Reported October 30, 2024
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
Spectrum Medical Ltd. recalled Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood th… - a moderate-severity action.
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood th… was recalled by Spectrum Medical Ltd. in October 30, 2024. Reason: The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.. Check the official notice for the remedy. Verify recall #Z-0224-2025 with the FDA Devices before acting.
The recall
Spectrum Medical Ltd. issued this moderate-severity FDA Devices recall-The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock..
- Moderate
- severity level
- 172 units
- affected scope
- Class II
- classification
- October 30, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0224-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0224-2025) was formally reported on October 30, 2024, with the manufacturer initiating the action on March 13, 2023. It is classified under Moderate severity (Class II), with a current status of Completed. Spectrum Medical Ltd. is listed as the recalling firm, operating out of Gloucester, N/A. Federal records list the affected scope as 172 units.
The documented reason for this recall is: The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock. Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Tex…. 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
172 units
Related Recalls
6
3 from same agency
Product description
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
Reason for recall
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | Z-0224-2025 |
| Date reported | October 30, 2024 |
| Date initiated | March 13, 2023 |
| Recalling firm | Spectrum Medical Ltd. |
| Firm location | Gloucester, N/A |
| Affected scope | 172 units |
| Distribution | US Nationwide distribution including in the states of Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, West Virgi… |
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-0224-2025) 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? ▼
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00. Recalled by Spectrum Medical Ltd.. Units affected: 172 units.
Why was this product recalled? ▼
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2024. Severity: Moderate. Recall number: Z-0224-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution including in the states of Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, West Virginia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0224-2025) 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 October 30, 2024. 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.