FDA Device Intelligence
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Catheter, Recording, Electrode, Reprocessed

FDA product code NLH · Class 2 · Cardiovascular

2,140
Registered devices
474
Adverse events
49
Recalls
70
510(k) clearances

Devices with this code

N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.N/A — INNOVATIVE HEALTH LLCN/A — INNOVATIVE HEALTH LLCNA — STERILMED, INC.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.N/A — INNOVATIVE HEALTH LLCN/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.MEDLINE — MEDLINE INDUSTRIES, INC.N/A — INNOVATIVE HEALTH LLCN/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.NA — STERILMED, INC.NA — STERILMED, INC.NA — STERILMED, INC.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.MEDLINE — MEDLINE INDUSTRIES, INC.NA — STERILMED, INC.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.N/A — INNOVATIVE HEALTH LLC

Recent recalls

DateFirmReason
2026-08-18Stryker Sustainability SolutionsDiagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to parti
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 patien
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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.