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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 1741–1760 of 39,430 recalls

Class IIOngoing

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Fresenius Kabi USA, LLC

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

November 3, 2025 · DeviceView details →

Class IIOngoing

Alcohol (ALC) Test Saliva

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class II

Ongoing

Gut Microbiome Test XL

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Pet Allergy Test

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIIOngoing

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;

Orthofix U.S. LLC

Labeling contains claims that are not consistently present.

November 3, 2025 · DeviceView details →

Class IIOngoing

Urinary Tract Infection Test

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Lactose Intolerance Test

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

PSA Test

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Gut Microbiome Test Small

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

8 in 1 STI Test Kit

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Akkermansia Test

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Food Intolerance Test Medium

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

GE Healthcare GmbH

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.

November 3, 2025 · DeviceView details →

Class IIOngoing

Food Sensitivity Test Large

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

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.

Fresenius Kabi USA, LLC

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

November 3, 2025 · DeviceView details →

Class IIOngoing

Mycotoxin Panel Test

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Food Sensitivity Test Small

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Allergy test Small

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Peptic Ulcer Test (H, pylori)

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Heavy Metals Test

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

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