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 351 of 1190
FDA device recalls, page 351 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1655-2020Class IIBIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone...Zimmer GmbHKWY
Z-1654-2020Class IIBIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone...Zimmer GmbHKWY
Z-1653-2020Class IIBIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone...Zimmer GmbHKWY
Z-1652-2020Class IIBIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM...Zimmer GmbHKWY
Z-1651-2020Class IIBIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM...Zimmer GmbHKWY
Z-1650-2020Class IIBIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM...Zimmer GmbHKWY
Z-1649-2020Class IIBIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM...Zimmer GmbHKWY
Z-1648-2020Class IIBIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM...Zimmer GmbHKWY
Z-1647-2020Class IIBIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM...Zimmer GmbHKWY
Z-1646-2020Class IIBIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM...Zimmer GmbHKWY
Z-1645-2020Class IIBIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM...Zimmer GmbHKWY
Z-1644-2020Class IIBIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM...Zimmer GmbHKWY
Z-1643-2020Class IIBIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM...Zimmer GmbHKWY
Z-1642-2020Class IIBIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.Zimmer GmbHKWY
Z-1641-2020Class IIBIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.Zimmer GmbHKWY
Z-1640-2020Class IIBIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.Zimmer GmbHKWY
Z-1639-2020Class IIBIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.Zimmer GmbHKWY
Z-1758-2020Class IIClearCanvas RIS/PACSSynaptive Medical IncLLZ
Z-1638-2020Class IIBIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.Zimmer GmbHKWY
Z-1499-2020Class IIHeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC...Philips North America LLCMKJ
Z-1824-2020Class IINexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref...Sybron Dental Specialties, Inc.EMA
Z-1771-2020Class IIAcutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated...Acutus Medical, Inc.DYB
Z-1770-2020Class IIRhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal...Acutus Medical, Inc.DYB
Z-1769-2020Class IIAcutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated...Acutus Medical, Inc.DYB
Z-1768-2020Class IIRhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal...Acutus Medical, Inc.DYB
Z-1615-2020Class IIBiomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper...Zimmer GmbHPHX
Z-1600-2020Class IIButterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a...Butterfly Network, Inc.IYN
Z-1601-2020Class IIButterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model...Butterfly Network, Inc.IYN
Z-1498-2020Class IILivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to...LivaNova USA, Inc.DWC
Z-1850-2020Class IIR-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI...Epimed International, Inc.GXI
Z-1849-2020Class IIR-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI...Epimed International, Inc.GXI
Z-1636-2020Class IIAmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box)...QiagenNQM
Z-1755-2020Class IITCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4...Radiometer Medical ApSLKD
Z-1603-2020Class IIAvalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039Maquet Cardiovascular Us Sales, LLCDRE
Z-1616-2020Class IIExpression MR400 MRI Patient Monitoring System Model Number: 866185 Software version...Philips North America LLCMWI
Z-1468-2020Class IIRayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning...RaySearch Laboratories AB (publ)MUJ
Z-1467-2020Class IIRayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning...RaySearch Laboratories AB (publ)MUJ
Z-1466-2020Class IIRayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software...RaySearch Laboratories AB (publ)MUJ
Z-1465-2020Class IIRayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software...RaySearch Laboratories AB (publ)MUJ
Z-1464-2020Class IIRayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning...RaySearch Laboratories AB (publ)MUJ
Z-1463-2020Class IIRayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software...RaySearch Laboratories AB (publ)MUJ
Z-1462-2020Class IIRayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning...RaySearch Laboratories AB (publ)MUJ
Z-1617-2020Class IITEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0...Haemonetics CorporationJPA
Z-0589-2022Class IIQC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel...Microbiologics, Inc.JTR
Z-0588-2022Class IIQC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains...Microbiologics, Inc.JTR
Z-0587-2022Class IIQC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains...Microbiologics, Inc.JTR
Z-0586-2022Class IILYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control...Microbiologics, Inc.JTR
Z-0585-2022Class IIKWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack...Microbiologics, Inc.JTR
Z-1680-2020Class IIPRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9...Siemens Medical Solutions USA, Inc.IYE
Z-1679-2020Class IIONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR...Siemens Medical Solutions USA, Inc.IYE