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Week of Nov 3, 2025

50

Nov 3, 2025device 510k286d agoPie Medical Imaging BV — 3mensio Workstation (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Nov 3, 2025device 510k286d agoFUJIFILM Sonosite, Inc. — Sonosite MT Ultrasound System (510k cleared)

Product code: IYN. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Nov 3, 2025device 510k286d agoMidmark Corporation — Midmark Dental Delivery System (510k cleared)

Product code: EIA. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Nov 3, 2025device 510k286d agoHebei Dansong Medical Technology Co., Ltd. — Electric wheelchair (NSDS-01) (510k cleared)NewBay Medical Technology Co Ltd

Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗

Nov 3, 2025device 510k286d agoNightguard Express, LLC — NightGuard Aire Max (510k cleared)

Product code: LRK. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Nov 3, 2025device pma286d agoBeckman Coulter, Inc. — Access AFP (on DxI 9000 Analyzer) (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LOK. Advisory committee: IM. Decision: APPR

full page →fda device pma ↗

Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Food Intolerance Test Small — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Vitamin D-Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Candida Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Organic Acids Profile Test Large — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Allergy Test IgE — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Allergy test Small — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

GI Microbiome Profile XL — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Illegally Marketed — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

HPV Antigen Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Sperm Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Mycoplasma test, IgG and IgM — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

full page →fda device recalls ↗

Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Parasite Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Adrenal Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Neurotransmitters Plus — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Pollen Allergy Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoFresenius Kabi USA, LLC device recall (Cls II)Fresenius Kabi USA LLC

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. — Reason: Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Alcohol (ALC) Test Saliva — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Gut Microbiome Test XL — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Pet Allergy Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoOrthofix U.S. LLC device recall (Cls III)

Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H; 38-2009SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 9H; 38-2010SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 10H; 38-2011SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 11H; 38-2012SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 12H; 38-2013SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 13H; 38-2014SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 14H; 38-2106SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 6H; 38-2107SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 7H; 38-2108SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 8H; 38-2109SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 9H; 38-2110SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 10H; 38-2111SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 11H; 38-2112SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 12H; 38-2113SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 13H; 38-2114SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 14H; 38-2206SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 6H; 38-2207SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 7H; 38-2208SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 8H; 38-2209SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 9H; 38-2210SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 10H; 38-2211SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 11H; 38-2212SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 12H; 38-2213SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 13H; 38-2214SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 14H; 38-2309SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 9H; 38-2310SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 10H; 38-2311SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 11H; 38-2312SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 12H; 38-2313SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 13H; 38-2314SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 14H; 38-2508SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 8H; 38-2509SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 9H; 38-2510SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 10H; 38-2511SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 11H; 38-2512SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 12H; 38-2513SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 13H; 38-2514SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 14H; 38-3206SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 6H; 38-3207SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 7H; 38-3208SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 8H; 38-3209SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 9H; 38-3210SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 10H; 38-3211SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 11H; 38-3212SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 12H; 38-3213SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 13H; 38-3214SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 14H; 38-3409SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 9H; 38-3410SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 10H; 38-3411SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 11H; 38-3412SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 12H; — Reason: Labeling contains claims that are not consistently present. — Status: Ongoing

Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Urinary Tract Infection Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

full page →fda device recalls ↗

Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Lactose Intolerance Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

full page →fda device recalls ↗

Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

PSA Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Gut Microbiome Test Small — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

8 in 1 STI Test Kit — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Akkermansia Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Food Intolerance Test Medium — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGE Healthcare GmbH device recall (Cls II)

GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system — Reason: GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Food Sensitivity Test Large — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoFresenius Kabi USA, LLC device recall (Cls I)Fresenius Kabi USA LLC

IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set. — Reason: Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Mycotoxin Panel Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Food Sensitivity Test Small — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

full page →fda device recalls ↗

Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Allergy test Small — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Peptic Ulcer Test (H, pylori) — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Heavy Metals Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Fructose Intolerance Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Trichomonas Vaginalis test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

SIBO Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Intestinal Worms Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

D-Dimer Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Diabetes HbA1c Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Candida Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Syphilis Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Iodine Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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