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 153 of 1190
FDA device recalls, page 153 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1806-2024Class IInamic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1590-2024Class IISmartPath to dStream for XR and 3.0T, Magnetic Resonance System.Philips North America LLCLNH
Z-1589-2024Class IISmartPath to dStream for 1.5T, Magnetic Resonance System.Philips North America LLCLNH
Z-1588-2024Class IIMR 7700, Magnetic Resonance System.Philips North America LLCLNH
Z-1587-2024Class IIMR 5300, Magnetic Resonance System.Philips North America LLCLNH
Z-1586-2024Class IIIntera CV, Magnetic Resonance System.Philips North America LLCLNH
Z-1585-2024Class IIIntera Achieva 1.5T Pulsar, Magnetic Resonance System.Philips North America LLCLNH
Z-1584-2024Class IIIntera 3.0T Quasar Dual, Magnetic Resonance System.Philips North America LLCLNH
Z-1583-2024Class IIIntera 1.5T R11, Magnetic Resonance System.Philips North America LLCLNH
Z-1582-2024Class IIIntera 1.5T Power/Pulsar, Magnetic Resonance System.Philips North America LLCLNH
Z-1581-2024Class IIIntera 1.5T Omni/Stellar, Magnetic Resonance System.Philips North America LLCLNH
Z-1580-2024Class IIIntera 1.5T Master/Nova, Magnetic Resonance System.Philips North America LLCLNH
Z-1579-2024Class IIIntera 1.5T Explorer/Nova Dual, Magnetic Resonance System.Philips North America LLCLNH
Z-1578-2024Class IIIntera 1.5T Achieva Nova-Dual, Magnetic Resonance System.Philips North America LLCLNH
Z-1577-2024Class IIIntera 1.5T Achieva Nova, Magnetic Resonance System.Philips North America LLCLNH
Z-1576-2024Class IIIntera 1.5T Achieva IT Nova, Magnetic Resonance System.Philips North America LLCLNH
Z-1575-2024Class IIIntera 1.5T, Magnetic Resonance System.Philips North America LLCLNH
Z-1574-2024Class IIIntera 1.0T Power/Pulsar, Magnetic Resonance System.Philips North America LLCLNH
Z-1573-2024Class IIIntera 1.0T Omni/Stellar, Magnetic Resonance System.Philips North America LLCLNH
Z-1572-2024Class IIIntera 0.5T Standard, Magnetic Resonance System.Philips North America LLCLNH
Z-1571-2024Class IIIngenia Elition X, Magnetic Resonance System.Philips North America LLCLNH
Z-1570-2024Class IIIngenia Elition S, Magnetic Resonance System.Philips North America LLCLNH
Z-1569-2024Class IIIngenia Ambition X, Magnetic Resonance System.Philips North America LLCLNH
Z-1568-2024Class IIIngenia Ambition S, Magnetic Resonance System.Philips North America LLCLNH
Z-1567-2024Class IIIngenia 3.0T CX, Magnetic Resonance System.Philips North America LLCLNH
Z-1566-2024Class IIIngenia 3.0T, Magnetic Resonance System.Philips North America LLCLNH
Z-1565-2024Class IIIngenia 1.5T S, Magnetic Resonance System.Philips North America LLCLNH
Z-1564-2024Class IIIngenia 1.5T CX, Magnetic Resonance System.Philips North America LLCLNH
Z-1563-2024Class IIIngenia 1.5T, Magnetic Resonance System.Philips North America LLCLNH
Z-1562-2024Class IIGYROSCAN T5-NT, Magnetic Resonance System.Philips North America LLCLNH
Z-1561-2024Class IIGYROSCAN T5, Magnetic Resonance System.Philips North America LLCLNH
Z-1560-2024Class IIGYROSCAN T10-NT, Magnetic Resonance System.Philips North America LLCLNH
Z-1559-2024Class IIGYROSCAN ACS-NT, Magnetic Resonance System.Philips North America LLCLNH
Z-1558-2024Class IIEvolution Upgrade 3.0T, Magnetic Resonance System.Philips North America LLCLNH
Z-1557-2024Class IIEnterprise 1.5T, Magnetic Resonance System.Philips North America LLCLNH
Z-1556-2024Class IIAchieva XR, Magnetic Resonance System.Philips North America LLCLNH
Z-1555-2024Class IIAchieva 3.0TX for PET, Magnetic Resonance System.Philips North America LLCLNH
Z-1554-2024Class IIAchieva 3.0T for PET, Magnetic Resonance System.Philips North America LLCLNH
Z-1553-2024Class IIAchieva 3.0T, Magnetic Resonance System.Philips North America LLCLNH
Z-1552-2024Class IIAchieva 1.5T Initial, Magnetic Resonance System.Philips North America LLCLNH
Z-1551-2024Class IIAchieva 1.5T Conversion, Magnetic Resonance System.Philips North America LLCLNH
Z-1550-2024Class IIAchieva 1.5T, Magnetic Resonance System.Philips North America LLCLNH
Z-1456-2024Class IIATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of...Depuy Orthopaedics Inc.MBH
Z-1696-2024Class IIOsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of...Advanced Instruments, LLCJJM
Z-1591-2024Class IIIdentity Imprint PS Tibial Tray Size 4: Lot 540287ConforMIS, Inc.JWH
Z-1597-2024Class IIRENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit...Smith & Nephew Medical LtdOMP
Z-1596-2024Class IIRENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit...Smith & Nephew Medical LtdOMP
Z-1463-2024Class IIUreteral dilator, REF RBD014MEDLINE INDUSTRIES, LP - NorthfieldEZN
Z-1329-2024Class IIHDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support...Baxter Healthcare CorporationHST
Z-1734-2024Class IIGalaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and...NOAH MEDICAL Corp.EOQ