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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-0285-2026Class 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 NJ3 unitscode info di
2025-06-10Z-0244-2026Class 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 NJ55 unitscode info di
2025-06-10Z-0245-2026Class 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 unitcode info di
2025-06-10Z-0246-2026Class 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 NJ268 unitscode info di
2025-06-10Z-0247-2026Class 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 unitscode info di
2025-06-10Z-0249-2026Class 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 NJ12 unitscode info di
2025-06-10Z-0250-2026Class 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 unitcode info di
2025-06-10Z-0251-2026Class 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 NJ12 unitscode info di
2025-06-10Z-0252-2026Class 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 NJ7 unitscode info di
2025-06-10Z-0281-2026Class 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 NJ24 unitscode info di
Showing 1–10 of 12
Regulatory clearances

None linked.

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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