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U.S. Department of Health and Human Services

Medical Device Recalls
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The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative me... 3 01/03/2025 Qualigen Inc
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the Merlin... 3 11/26/2024 Abbott Medical
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer sto... 3 11/26/2024 Abbott Medical
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can de... 3 11/26/2024 Remote Diagnostic Technologies Ltd.
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 ... 3 11/22/2024 Zyno Medical LLC
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING,... 3 11/19/2024 Alcon Research LLC
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in... 3 11/01/2024 Iotamotion Inc
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that include... 3 10/30/2024 Trackx Technology Inc
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic... 3 10/29/2024 DRG International, Inc.
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702,... 3 10/16/2024 Beckman Coulter, Inc.

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