FDASeptember 19, 2025device
Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative measurements to the surg...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
What to do
FDA enforcement status: Ongoing
Brands named
kico knee innovationkicokico knee
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCArctic Zone Titan Pro Coolers Recalled Due to Risk of Serious Injury or Death from Choking Hazard; Imported by California Innovations and Sold at Costco2026-06-11
- CPSCMerkury Innovations Recalls Hot + Cool Heating and Cooling Fans Due to Risk of Serious Injury or Death from Fire Hazard2026-06-11
- FDARoast beef and cheddar closed face sandwich packed in clear plastic wrap with a green adhesive label. The label reads in part as "***Lunch Box Kitchen*** Premium Convenience***Turkey & Cheddar Sub***BEST BY 06/14/26 Lot no. 26 134 NET WEIGHT: 6.1oz***KEEP REFRIGERATED*** Produced by: Produce Inno...2026-05-27
- FDAArvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C2026-04-23
- FDAArvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E2026-04-23
- FDABrand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide ass...2026-03-09
- FDAHIGHER HARVEST by H-E-B brand; Dairy Free Coconut Based YOGURT; STRAWBERRY; YOGURT ALTERNATIVE; NET WT 5.3 OZ; INGREDIENTS: COCONUT MILK (WATER, COCONUT CREAM, MODIFIED TAPIOCA STARCH), STRAWBERRIES, CANE SUGAR, WATER, STARCH, NATURAL FLAVOR, FRUITS AND VEGETABLE JUICE (FOR COLOR) LOCUST BEAN GUM...2025-12-17
- CPSCRomorgniz Fabric 12- and 13-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment; Violates Mandatory Standard for Clothing Storage Units; Sold on Amazon by Romorgniz2025-11-20
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