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U.S. Department of Health and Human Services

Medical Device Recalls
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Product Description
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FDA Recall
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Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A. 2 07/10/2026 FEI # 2429304
Olympus Corporation of the Americas
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403;... 2 07/10/2026 FEI # 3013319212
ICU Medical, Inc.
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump 2 07/10/2026 FEI # 3013319212
ICU Medical, Inc.
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: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Descr... 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.
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.

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