510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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

59,486 records, page 391 of 1190
FDA device recalls, page 391 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1899-2019Class IISiemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281Siemens Medical Solutions USA, Inc.OWB
Z-1898-2019Class IISiemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280Siemens Medical Solutions USA, Inc.OWB
Z-1897-2019Class IISiemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959Siemens Medical Solutions USA, Inc.OWB
Z-1896-2019Class IISiemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141Siemens Medical Solutions USA, Inc.OWB
Z-1895-2019Class IISiemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137Siemens Medical Solutions USA, Inc.OWB
Z-1894-2019Class IISiemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135Siemens Medical Solutions USA, Inc.OWB
Z-2077-2019Class IIPulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The...Getinge US Sales LLCDXG
Z-2088-2019Class IFilter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the...QiagenJJH
Z-1943-2021Class IIIinLight Medical LED Pads used with Polychromatic light technology systemIn Light Therapy, Inc.ILY
Z-1922-2019Class IISOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA20A_SP0...Siemens Medical Solutions USA, Inc.JAK
Z-1921-2019Class IISOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, VA20A_SP0...Siemens Medical Solutions USA, Inc.JAK
Z-1920-2019Class IISOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0...Siemens Medical Solutions USA, Inc.JAK
Z-1919-2019Class IISOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0...Siemens Medical Solutions USA, Inc.JAK
Z-1938-2019Class IIPowerheart G5 Automatic AEDZOLL Medical CorporationMKJ
Z-1963-2019Class IIUltra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item...Zimmer GmbHJDX
Z-1962-2019Class IIUltra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with...Zimmer GmbHJDX
Z-1929-2019Class IIVereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and...Philips North America LLCKPS
Z-1979-2019Class IIThe Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with...Roche Diagnostics GmbHCZP
Z-2277-2019Class IISunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box...Suntech Medical, Inc.DXQ
Z-1967-2019Class IIBD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and...Becton Dickinson & CoJKA
Z-2545-2020Class IICenturion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD...Centurion Medical Products, LPJKA
Z-2395-2019Class IIGlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2394-2019Class IIGlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2393-2019Class IIGlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2392-2019Class IIGlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2391-2019Class IIGlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2390-2019Class IIGlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2389-2019Class IIGlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, Alphacurve...Bard Peripheral Vascular IncMSD
Z-2388-2019Class IIGlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, Alphacurve...Bard Peripheral Vascular IncMSD
Z-2387-2019Class IIGlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, Alphacurve...Bard Peripheral Vascular IncMSD
Z-2386-2019Class IIGlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2385-2019Class IIGlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2384-2019Class IIGlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2383-2019Class IIGlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2382-2019Class IIEQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2381-2019Class IIEQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2380-2019Class IIEQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2379-2019Class IIEQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2378-2019Class IIEQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2377-2019Class IIEQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2376-2019Class IIEQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F...Bard Peripheral Vascular IncMSD
Z-2375-2019Class IIEQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2374-2019Class IIEQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2373-2019Class IIEQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2372-2019Class IIEQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2371-2019Class IIEQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product...Bard Peripheral Vascular IncMSD
Z-2370-2019Class IIEQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve...Bard Peripheral Vascular IncMSD
Z-2369-2019Class IIEQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve...Bard Peripheral Vascular IncMSD
Z-2368-2019Class IIEQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve...Bard Peripheral Vascular IncMSD
Z-1909-2019Class IIREVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers...Baxter Healthcare CorporationKDI