Skip to content
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
2024-06-03Z-2639-2024Class IIOpen, ClassifiedDuring sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.Distribution: Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.10,366 cases (518,300 units)clearance family
2024-06-03Z-2640-2024Class IIOpen, ClassifiedDuring sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.Distribution: Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.135,999 cases (6,799,950 units)clearance family
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-04-22NAINo action indicatedMICROTEK MEDICAL LLC0
2018-06-15NAINo action indicatedMICROTEK MEDICAL LLC0
2016-08-03VAIVoluntary action indicatedMicrotek Medical Inc4
2011-06-22NAINo action indicatedMicrotek Medical Inc0
Similar devices
Select up to two to place side-by-side with this device.