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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 345 of 1190
FDA device recalls, page 345 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2114-2020Class IIFlexLab Automation System used with the following Modules: High Volume Storage(P/N...Inpeco S.p.A.CEM
Z-1806-2020Class IIPhilips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product...Philips North America LLCKPR
Z-2200-2020Class IIAptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage...Inpeco S.p.A.CEM
Z-2199-2020Class IIAccelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212)...Inpeco S.p.A.CEM
Z-2198-2020Class IIFlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems...Inpeco S.p.A.CEM
Z-2004-2020Class IIAbbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers...Inpeco S.p.A.CEM
Z-2003-2020Class IIInpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers...Inpeco S.p.A.CEM
Z-2142-2020Class IIAptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10)...Inpeco S.p.A.JQP
Z-2141-2020Class IIAccelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00...Inpeco S.p.A.JQP
Z-2140-2020Class IIFlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00...Inpeco S.p.A.JQP
Z-1889-2020Class IISiemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N...Inpeco S.p.A.JJE
Z-1888-2020Class IIAbbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N...Inpeco S.p.A.JJE
Z-1887-2020Class IIInpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with...Inpeco S.p.A.JJE
Z-1882-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1881-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1880-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1879-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1878-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1877-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1876-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1875-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1874-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1873-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1872-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1871-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1870-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1869-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1868-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1867-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1866-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1865-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1864-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code...Maquet Cardiovascular LLCMAL
Z-1863-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code...Maquet Cardiovascular LLCMAL
Z-1862-2020Class IIHEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code...Maquet Cardiovascular LLCMAL
Z-1861-2020Class IIHemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product...Maquet Cardiovascular LLCMAL
Z-1860-2020Class IIHemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product...Maquet Cardiovascular LLCMAL
Z-1859-2020Class IIHemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product...Maquet Cardiovascular LLCMAL
Z-2066-2020Class IIPrismaflex Control UnitBaxter Healthcare CorporationKDI
Z-2636-2020Class IIEXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product...Skeletal Kinetics, LLCMQV
Z-2635-2020Class IICRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - Product...Skeletal Kinetics, LLCGXP
Z-2634-2020Class IICRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product...Skeletal Kinetics, LLCGXP
Z-2633-2020Class IICRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product...Skeletal Kinetics, LLCGXP
Z-2632-2020Class IICRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product...Skeletal Kinetics, LLCGXP
Z-2631-2020Class IISKAFFOLD RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - Product Usage...Skeletal Kinetics, LLCMQV
Z-2630-2020Class IISKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Product Usage...Skeletal Kinetics, LLCMQV
Z-2629-2020Class IISKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos...Skeletal Kinetics, LLCGXP
Z-2628-2020Class IISKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage...Skeletal Kinetics, LLCGXP
Z-2627-2020Class IISKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI...Skeletal Kinetics, LLCGXP
Z-2626-2020Class IISKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product...Skeletal Kinetics, LLCMQV
Z-2625-2020Class IISKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - Product...Skeletal Kinetics, LLCMQV