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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 367 of 1190
FDA device recalls, page 367 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0910-2020Class IIGIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product...Collagen Matrix, IncNPL
Z-0909-2020Class IIGIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage...Collagen Matrix, IncNPL
Z-0908-2020Class IIGIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage...Collagen Matrix, IncNPL
Z-0907-2020Class IIGIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage...Collagen Matrix, IncNPL
Z-0788-2020Class IIHaylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP...Halyard HealthBSY
Z-2591-2020Class IITrinias DAP Meter, a component of the Digital Anglo System Trinias contained within the...Shimadzu Medical SystemsOWB
Z-2301-2020Class IIHistoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which...IMMY, Inc.GMJ
Z-1635-2020Class II8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only...Trilliant Surgical LLCHTY
Z-0775-2020Class IIMedacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055...Medacta USA, Inc.KWS
Z-0691-2020Class IIAscension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The...Integra Lifesciences Sales LLCKYJ
Z-0766-2020Class IIApollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table...Villa Sistemi Medicali S.p.A.KXJ
Z-0765-2020Class IIApollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo...Villa Sistemi Medicali S.p.A.KXJ
Z-0764-2020Class IIApollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is...Villa Sistemi Medicali S.p.A.KXJ
Z-0763-2020Class IIJuno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems...Villa Sistemi Medicali S.p.A.KXJ
Z-0518-2020Class IISite~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human...Becton Dickinson & CoIYO
Z-0666-2020Class IIHealix Knotless ADV BR 5.5 Suture AnchorDePuy Mitek, Inc.MAI
Z-0665-2020Class IIHealix Knotless ADV BR 4.75 Suture AnchorDePuy Mitek, Inc.MAI
Z-0082-2022Class IIBioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent...Bio-Rad Laboratories Inc.LKJ
Z-0703-2020Class IIHUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The...Teleflex MedicalCBI
Z-0698-2020Class IIAnesthesia Pediatric Circuit 72", Model DYNJAPF6057AMEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-0661-2020Class IIOral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product...Young Dental Manufacturing Co 1, LLC.LBH
Z-0598-2020Class IIXEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model...AllerganKYF
Z-0659-2020Class IIBiopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108Medtronic Navigation, IncHAW
Z-0658-2020Class IIBiopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517Medtronic Navigation, IncHAW
Z-0657-2020Class IIPassive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943Medtronic Navigation, IncHAW
Z-0705-2020Class IIHydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24...BSG CorpKOY
Z-0704-2020Class IIHydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for...BSG CorpKOY
Z-0914-2020Class IIiQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325...Siemens Healthcare Diagnostics Inc.LKM
Z-0913-2020Class IIiChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001...Siemens Healthcare Diagnostics Inc.KQO
Z-0669-2020Class IIElecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to...Roche Diagnostics GmbHLOL
Z-0610-2020Class IMedfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and...Abbott MedicalFRN
Z-0994-2020Class IIGenius 2 Tympanic Thermometer Private Label Item Code: 3069Medtronic, Inc.FLL
Z-0993-2020Class IIGenius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063Medtronic, Inc.FLL
Z-0992-2020Class IIGenius 2 Tympanic Thermometer OEM Tympanic Item Code:303062Medtronic, Inc.FLL
Z-0991-2020Class IIGenius 3 Tympanic Thermometer- electric thermometer Item Code: 303013Medtronic, Inc.FLL
Z-0990-2020Class IIGenius 2 Tympanic Thermometer (discontinued) Item Code: 303000Medtronic, Inc.FLL
Z-0724-2020Class IIBARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy...Bard Peripheral Vascular IncKNW
Z-0672-2020Class IIiTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The...ConforMIS, Inc.JWH
Z-0595-2020Class IIBiomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical...Zimmer GmbHLXH
Z-0594-2020Class IIBiomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical...Zimmer GmbHLXH
Z-0404-2020Class IIVisual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console...Galil Medical Ltd.GEH
Z-1848-2020Class IApplied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF...Applied Medical Resources CorpDXE
Z-1847-2020Class IBard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R...Applied Medical Resources CorpDXE
Z-1846-2020Class IPython Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407...Applied Medical Resources CorpDXE
Z-0344-2020Class IICenturion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955Centurion Medical Products, LPLRO
Z-0580-2020Class IIRebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS...Boston Scientific CorporationMAF
Z-0579-2020Class IINC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged...Boston Scientific CorporationLOX
Z-0578-2020Class IIGuidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the...Boston Scientific CorporationDQY
Z-0577-2020Class IIEmerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in...Boston Scientific CorporationLOX
Z-2162-2020Class IIGentlewave Ref: Fg-002-0001Sonendo IncELC