Severity
Moderate
ModerateClass IICompleted
FDA Devices recall · Reported November 1, 2023
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
SynCardia Systems LLC recalled SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO - a moderate-severity action.
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO was recalled by SynCardia Systems LLC in November 1, 2023. Reason: Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.. Check the official notice for the remedy. Verify recall #Z-0126-2024 with the FDA Devices before acting.
The recall
SynCardia Systems LLC issued this moderate-severity FDA Devices recall-Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy..
- Moderate
- severity level
- 114 units
- affected scope
- Class II
- classification
- November 1, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0126-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0126-2024) was formally reported on November 1, 2023, with the manufacturer initiating the action on August 1, 2023. It is classified under Moderate severity (Class II), with a current status of Completed. SynCardia Systems LLC is listed as the recalling firm, operating out of Tucson, AZ. Federal records list the affected scope as 114 units.
The documented reason for this recall is: Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy. Distribution data in the federal record shows the product reached: US: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi Arabia, Austria, Italy, Macedonia, Turkey, Germany, France, Kuwait, Serbia, United Kingdom, Canada, Lithuania, Slovenia Australia. 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
114 units
Related Recalls
6
3 from same agency
Product description
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Reason for recall
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | Z-0126-2024 |
| Date reported | November 1, 2023 |
| Date initiated | August 1, 2023 |
| Recalling firm | SynCardia Systems LLC |
| Firm location | Tucson, AZ |
| Affected scope | 114 units |
| Distribution | US: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi Arabia, Austria, Italy, Macedonia, Turkey, Germany, France, Kuwait, Serbia, United Kingdom, Canada, Lithuania, Slovenia Australia |
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-0126-2024) 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? ▼
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO. Recalled by SynCardia Systems LLC. Units affected: 114 units.
Why was this product recalled? ▼
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 1, 2023. Severity: Moderate. Recall number: Z-0126-2024.
Where was the recalled product distributed? ▼
Distribution: US: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi Arabia, Austria, Italy, Macedonia, Turkey, Germany, France, Kuwait, Serbia, United Kingdom, Canada, Lithuania, Slovenia Australia.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0126-2024) 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 November 1, 2023. 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.