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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2025-06-10Z-0253-2026Class IIOpen, ClassifiedSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.Distribution: US: CA, IL, and NJ1 unitclearance family
2025-06-10Z-0254-2026Class IIOpen, ClassifiedSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.Distribution: US: CA, IL, and NJ1 unitclearance family
2025-06-10Z-0255-2026Class IIOpen, ClassifiedSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.Distribution: US: CA, IL, and NJ8 unitsclearance family
2025-06-10Z-0256-2026Class IIOpen, ClassifiedSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.Distribution: US: CA, IL, and NJ22 unitscode info di
2025-06-10Z-0257-2026Class IIOpen, ClassifiedSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.Distribution: US: CA, IL, and NJ6 unitsclearance family
2025-06-10Z-0258-2026Class IIOpen, ClassifiedSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.Distribution: US: CA, IL, and NJ39 unitsclearance family
2025-06-10Z-0259-2026Class IIOpen, ClassifiedSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.Distribution: US: CA, IL, and NJ1 unitclearance family
2025-06-10Z-0260-2026Class IIOpen, ClassifiedSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.Distribution: US: CA, IL, and NJ14 unitsclearance family
2025-06-10Z-0261-2026Class IIOpen, ClassifiedSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.Distribution: US: CA, IL, and NJ9 unitsclearance family
2025-06-10Z-0262-2026Class IIOpen, ClassifiedSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.Distribution: US: CA, IL, and NJ8 unitsclearance family
Showing 1–10 of 31
Regulatory clearances

    Predicate lineage

    K090322

    Cited as predicate by: K103597, K111725, K142492

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record
    DateTypeOutcomeFacilityCitations
    2025-01-24OAIOfficial action indicatedSEDECAL SA4
    2013-06-28VAIVoluntary action indicatedSEDECAL SA2
    2010-01-15NAINo action indicatedSEDECAL SA0
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