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CARDINAL HEALTH

Cardinal Health 200, LLC · Model SAN63SPS15 · UDI-DI 10197106979693

OEQ Prescription
0
510(k) clearances
494
Adverse events (1 deaths)
89
Recalls
49
Facilities

Description

SPECIAL PROCEDURES PACK

Recalls

DateFirmReason
2026-06-17Windstone Medical Packaging, Inc.Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. El
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, LPFirm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
2026-02-27Medline Industries, LPUnapproved design changes to the products outside of the 510(k) clearance.
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.