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U.S. Department of Health and Human Services

Medical Device Recalls

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7.5MHZ Endo Transducer Probe 3 08/22/2025 FEI # 2518586
Philips Ultrasound, Inc
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 3 08/14/2025 FEI # 2023374
Diversatek Healthcare
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PY... 3 08/13/2025 FEI # 2016493
CareFusion 303, Inc.
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product De... 3 08/04/2025 FEI # 2245285
DRG International, Inc.
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fa... 3 07/07/2025 FEI # 3017374693
STRATASYS LTD
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fab... 3 07/07/2025 FEI # 3017374693
STRATASYS LTD
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fa... 3 07/07/2025 FEI # 3017374693
STRATASYS LTD
TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables f... 3 07/07/2025 FEI # 3017374693
STRATASYS LTD
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

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