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MEDLINE INDUSTRIES, INC. · Model 401381RH · UDI-DI 10197344043545

NLH Prescription
1
510(k) clearances
449
Adverse events (1 deaths)
48
Recalls
11
Facilities

Description

SJM DIAG EP CATH FIXD CSL 10POLE 282 6FR

Recalls

DateFirmReason
2026-05-15Medline Industries, LPExpansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surface
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product

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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.