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U.S. Department of Health and Human Services

Medical Device Recalls
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TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fab... 3 07/07/2025 FEI # 3017374693
STRATASYS LTD
Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macul... 3 06/30/2025 FEI # 3016232028
LUMITHERA INC
AcoSound. Model Number: LW12-BTE-M 3 06/13/2025 FEI # 3011350813
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
Apo B Reagent, REF: OSR6143 3 05/23/2025 FEI # 1000206808
Beckman Coulter Ireland, Inc.
The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative me... 3 01/03/2025 FEI # 3003355251
Qualigen Inc
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the Merlin... 3 11/26/2024 FEI # 2017865
Abbott Medical
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer sto... 3 11/26/2024 FEI # 2017865
Abbott Medical
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can de... 3 11/26/2024 FEI # 3003832357
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 FEI # 3006575795
Zyno Medical LLC
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING,... 3 11/19/2024 FEI # 1610287
Alcon Research LLC

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