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Merit Medical®

Merit Medical Systems, Inc. · Model 00884450654934 · UDI-DI 00884450654934

OEQ
0
510(k) clearances
528
Adverse events (1 deaths)
90
Recalls
49
Facilities

Recalls

DateFirmReason
2026-09-02Medline Industries, LPMedical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin
2026-06-17Windstone Medical Packaging, Inc.Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Li
2026-05-04Medline Industries, LPDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac
2026-04-02Merit Medical Systems, Inc.catheter may experience resistance when being advanced over the guidewire
2026-04-02Merit Medical Systems, Inc.catheter may experience resistance when being advanced over the guidewire
2026-04-02Merit Medical Systems, Inc.catheter may experience resistance when being advanced over the guidewire
2026-03-24Medline Industries, LPMedline has identified the presence of particulate within the fluid path of the Manifolds.
2026-03-19Medline Industries, LPDuring an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o
2026-02-27Medline Industries, LPMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection
2026-02-27Medline Industries, LPFirm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.