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 128 of 1190
FDA device recalls, page 128 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2650-2024Class IIProduct Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number...Alcon LaboratoriesHNN
Z-2649-2024Class IIProduct Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual...Alcon LaboratoriesHNN
Z-2648-2024Class IIProduct Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product...Alcon LaboratoriesLRO
Z-2647-2024Class IIProduct Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software...Alcon LaboratoriesHQC
Z-2646-2024Class IIProduct Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software...Alcon LaboratoriesHQC
Z-2645-2024Class IIProduct Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number...Alcon LaboratoriesHNN
Z-1745-2025Class IIBrand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number...Meddev CorpNCB
Z-1744-2025Class IIBrand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number...Meddev CorpNCB
Z-1529-2025Class IIDxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device...Siemens Healthcare Diagnostics Inc.JJE
Z-0084-2025Class IAuxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV...GE HealthcareBSZ
Z-2733-2024Class IIGE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973...GE Healthcare (China) Co., Ltd.KPR
Z-2720-2024Class IIIon Endoluminal System, REF: 380748-65Intuitive Surgical, Inc.EOQ
Z-0083-2025Class IAisys CS2 with Et Control. This anesthesia gas machine is intended to provide general...GE HealthcareQSF
Z-0082-2025Class IAisys CS2. This anesthesia gas machine is intended to provide general inhalation...GE HealthcareBSZ
Z-0081-2025Class IAisys. This anesthesia gas machine is intended to provide general inhalation anesthesia...GE HealthcareBSZ
Z-0080-2025Class IAvance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide...GE HealthcareBSZ
Z-0079-2025Class IAmingo. OUS only.GE HealthcareN/A
Z-0078-2025Class IAvance. This anesthesia gas machine is intended to provide general inhalation anesthesia...GE HealthcareBSZ
Z-0077-2025Class IAespire View. This anesthesia gas machine is intended to provide general inhalation...GE HealthcareBSZ
Z-0076-2025Class IAespire 7900. This anesthesia gas machine is intended to provide general inhalation...GE HealthcareBSZ
Z-0075-2025Class IAespire 100. This anesthesia gas machine is intended to provide general inhalation...GE HealthcareBSZ
Z-0074-2025Class IAespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These...GE HealthcareBSZ
Z-2535-2024Class IIINavaClick Syringe and Needle, Model Number LIN02Lineage Biomedical, IncFMF
Z-2543-2024Class IRMU-2000 Automated Chest Compression DeviceDefibtech LLCDRM
Z-3152-2024Class II2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product...Medtronic, Inc.NVZ
Z-3180-2024Class IIBeckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic...Siemens Healthcare Diagnostics Inc.JJE
Z-3062-2024Class IIGuidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with...Bard Peripheral Vascular IncDQX
Z-2693-2024Class IIIBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam...Ion Beam Applications S.A.LHN
Z-2691-2024Class IIDxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer...Beckman Coulter Mishima K.K.JJE
Z-2684-2024Class IIThe VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an...Ortho-Clinical Diagnostics, Inc.CIX
Z-3172-2024Class IIDIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastenerSmith & Nephew, Inc.HTY
Z-3171-2024Class IIDIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastenerSmith & Nephew, Inc.HTY
Z-3128-2024Class IIMedtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312Medtronic Perfusion SystemsDWF
Z-2948-2024Class IIBKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet systemCareFusion 303, IncBRY
Z-2947-2024Class IIBD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet systemCareFusion 303, IncBRY
Z-2637-2024Class IMcGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx OnlyMedtronic, Inc.CCW
Z-2636-2024Class IMcGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx OnlyMedtronic, Inc.CCW
Z-2717-2024Class IICovideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnlyMedtronic, Inc.CCW
Z-2621-2024Class IIAurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora...DKK Dai-Ichi Shomei Co., Ltd.FSY
Z-2620-2024Class IIAurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora...DKK Dai-Ichi Shomei Co., Ltd.FSY
Z-2619-2024Class IIAurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora...DKK Dai-Ichi Shomei Co., Ltd.FSY
Z-2618-2024Class IIAurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series...DKK Dai-Ichi Shomei Co., Ltd.FSY
Z-2585-2024Class IIBD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog...Becton Dickinson & CoKZB
Z-2507-2024Class IITruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction...Integra LifeSciences CorporationPGW
Z-2715-2024Class IIGM60A. Digital Diagnostic Mobile X-Ray System.Samsung HME America, Inc.IZL
Z-3089-2024Class IIIBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions...Ion Beam Applications S.A.LHN
Z-3130-2024Class IIMedtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069Medtronic Xomed, Inc.EQJ
Z-2622-2024Class IIIProduct Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product...DRG International, Inc.CDZ
Z-2941-2024Class IIFRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM SystemOrthopediatrics Canada ULCLXH
Z-2580-2024Class IIVITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2Ortho-Clinical Diagnostics, Inc.CGN