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Recall

Class II — LABORIE MEDICAL TECHNOLOGIES, CORP

Recalling firmLaborie Medical Technologies Corp.
Registered facilityLABORIE MEDICAL TECHNOLOGIES CORP. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonPower supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard
ProductU3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
Quantity2 US
DistributionUS distribution in AZ, and PA.
Initiated2019-07-17
Classified2019-07-25
Terminated2023-07-10
Recall numberZ-2076-2019
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — LABORIE MEDICAL TECHNOLOGIES, CORP (Z-2076-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83310/

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