510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,460 records, page 140 of 1190
FDA device recalls, page 140 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1954-2024Class IIADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftAtrium Medical CorporationDYF
Z-1953-2024Class IIADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftAtrium Medical CorporationDSY
Z-1952-2024Class IIADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftAtrium Medical CorporationDSY
Z-1951-2024Class IIADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftAtrium Medical CorporationDYF
Z-1950-2024Class IIHA FlexTrak II-Patient transport functionality to transport the patient from the...Philips North America LLCLNH
Z-1949-2024Class IIHA FlexTrak-Patient transport functionality to transport the patient from the preparation...Philips North America LLCLNH
Z-1948-2024Class IIHA FlexTrak-Patient transport functionality to transport the patient from the preparation...Philips North America LLCLNH
Z-1865-2024Class IIUpgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems...Philips North America LLCLNH
Z-1864-2024Class IISonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems...Philips North America LLCLNH
Z-1863-2024Class IISmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical...Philips North America LLCLNH
Z-1862-2024Class IISmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical...Philips North America LLCLNH
Z-1861-2024Class IISmartPath to dStream for 3.0T Model Number (REF): 782145Philips North America LLCLNH
Z-1860-2024Class IISmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical...Philips North America LLCLNH
Z-1859-2024Class IIMR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated...Philips North America LLCLNH
Z-1858-2024Class IIMR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use...Philips North America LLCLNH
Z-1857-2024Class IIMR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems...Philips North America LLCLNH
Z-1856-2024Class IIMarlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated...Philips North America LLCLNH
Z-1855-2024Class IIPanorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated...Philips North America LLCLNH
Z-1854-2024Class IIMR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for...Philips North America LLCLNH
Z-1853-2024Class IIIntera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for...Philips North America LLCLNH
Z-1852-2024Class IIIngenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems...Philips North America LLCLNH
Z-1851-2024Class IIIngenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems...Philips North America LLCLNH
Z-1850-2024Class IIIngenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359Philips North America LLCLNH
Z-1849-2024Class IIIngenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271Philips North America LLCLNH
Z-1848-2024Class IIIngenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated...Philips North America LLCLNH
Z-1847-2024Class IIIngenia 1.5T S Model Number (REF): 781347Philips North America LLCLNH
Z-1846-2024Class IIIngenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems...Philips North America LLCLNH
Z-1845-2024Class IIIngenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5)...Philips North America LLCLNH
Z-1844-2024Class IIEvolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143Philips North America LLCLNH
Z-1843-2024Class IIEvolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems...Philips North America LLCLNH
Z-1842-2024Class IIAchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for...Philips North America LLCLNH
Z-1841-2024Class IIAchieva 3.0T TX for PET Model Number (REF): 781479Philips North America LLCLNH
Z-1840-2024Class IIAchieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems...Philips North America LLCLNH
Z-1839-2024Class IIAchieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5)...Philips North America LLCLNH
Z-1838-2024Class IIAchieva 1.5T Initial system Model Number (REF): 781178Philips North America LLCLNH
Z-1837-2024Class IIAchieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems...Philips North America LLCLNH
Z-1836-2024Class IIAchieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated...Philips North America LLCLNH
Z-1889-2024Class IIBrand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION...Channel MedsystemsMNB
Z-2317-2024Class IIGE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SWGE Vingmed Ultrasound ASIYN
Z-2316-2024Class IIGE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95...GE Vingmed Ultrasound ASIYN
Z-2374-2024Class IIBD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia...CareFusion 303, IncBRY
Z-1926-2024Class IIPhilips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that...Philips Medical Systems Nederland B.V.MWI
Z-2213-2024Class IIThe D*Clot HD Rotational Thrombectomy System is a percutaneous catheter-based system...Mermaid Medical A/SQEW
Z-1877-2024Class IVaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of...Maquet Cardiovascular Us Sales, LLCBSZ
Z-2150-2024Class IITabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot)...Outset Medical, Inc.KDI
Z-2348-2024Class IISt. Jude Medical Agilis NxT Steerable Introducer, REF 408309Abbott MedicalDYB
Z-2130-2024Class IZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide...ZOLL Medical CorporationCBK
Z-2024-2024Class IIMEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual...MEDLINE INDUSTRIES, LP - NorthfieldJOK
Z-2326-2024Class IIDecompression Table Model E9011. This device applies cervical and/or lumbar decompression...Pivotal Health SolutionsITH
Z-2022-2024Class IIBrand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version...Verathon Inc.CCW