Merit Medical® Initial Release (REF K12T-12285A)Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jun 11, 2024Open, Classified
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-2579-2024 · Root cause: No Marketing Application · FDA record ↗
Other Angiography/angioplasty kit devices
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- Medline Industries, Inc. DYNJ0842873JMedline Industries, Inc. · Angiography/angioplasty kit3 recalls0 reports
- Merit Medical® 00884450255803Merit Medical Systems, Inc. · Angiography/angioplasty kit3 recalls0 reports
- Medline Industries, Inc. DYNJC2371GMedline Industries, Inc. · Angiography/angioplasty kit3 recalls0 reports
- Medline Industries, Inc. DYNJ40632CMedline Industries, Inc. · Angiography/angioplasty kit2 recalls1 report
- Medline Industries, Inc. DYNJ907452Medline Industries, Inc. · Angiography/angioplasty kit2 recalls0 reports
- Merit Medical® 00884450389683Merit Medical Systems, Inc. · Angiography/angioplasty kit2 recalls0 reports
- Merit Medical® 00884450515105Merit Medical Systems, Inc. · Angiography/angioplasty kit2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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