Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 19, 2025
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Spectrum Medical Inc recalled Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Produc… - a moderate-severity action.
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Produc… was recalled by Spectrum Medical Inc in March 19, 2025. Reason: Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or d…. Check the official notice for the remedy. Verify recall #Z-1327-2025 with the FDA Devices before acting.
The recall
Spectrum Medical Inc issued this moderate-severity FDA Devices recall-Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or d….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- March 19, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1327-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1327-2025) was formally reported on March 19, 2025, with the manufacturer initiating the action on January 16, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Spectrum Medical Inc is listed as the recalling firm, operating out of Fort Mill, SC. Federal records list the affected scope as 1487 unit.
The documented reason for this recall is: Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures. Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Massachusetts…. 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
1487 unit
Related Recalls
6
3 from same agency
Product description
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A
Reason for recall
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1327-2025 |
| Date reported | March 19, 2025 |
| Date initiated | January 16, 2025 |
| Recalling firm | Spectrum Medical Inc |
| Firm location | Fort Mill, SC |
| Affected scope | 1487 unit |
| Distribution | US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississ… |
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-1327-2025) 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? ▼
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A. Recalled by Spectrum Medical Inc. Units affected: 1487 unit.
Why was this product recalled? ▼
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 19, 2025. Severity: Moderate. Recall number: Z-1327-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, and Washington..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1327-2025) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 March 19, 2025. 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.