FDA Device Intelligence
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MICROLET®

ASCENSIA DIABETES CARE US INC. · Model 6586 / 6586W · UDI-DI 00301936586218

QRL
1
510(k) clearances
262
Adverse events
1
Recalls
86
Facilities

Description

Colored lancets. Silicone-coated lancets. Use with the MICROLET Family of lancing devices.

Recalls

DateFirmReason
2025-07-25Home Health US, IncorporatedDue to incorrect/lack of Unique Device Identifier (UDI) codes.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.