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U.S. Department of Health and Human Services

Medical Device Recalls
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GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORE... 2 07/09/2026 FEI # 3002808498
WALLAC OY
Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Numbe... 2 07/09/2026 FEI # 3015488559
CMR SURGICAL LIMITED
Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading ... 2 07/09/2026 FEI # 1037831
Elekta, Inc.
Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is inten... 2 07/09/2026 FEI # 1037831
Elekta, Inc.
Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Descr... 2 07/09/2026 FEI # 1037831
Elekta, Inc.
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes. 2 07/09/2026 FEI # 3003418325
Integra LifeSciences Corp. (NeuroSciences)
TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 10... 2 07/09/2026 FEI # 3000719653
Think Surgical, Inc.
VITEK 2 AST-N447 TEST KIT Product reference 424620 2 07/09/2026 FEI # 1950204
Biomerieux Inc
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 2 07/08/2026 FEI # 3003166194
Medtronic MiniMed, Inc.
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PA... 2 07/08/2026 FEI # 1417592
Medline Industries, LP

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