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

59,336 records, page 6 of 1187
FDA device recalls, page 6 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3070-2026Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-3069-2026Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN...MEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-3068-2026Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-3067-2026Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP...MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-3038-2026Class IIPORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353GE Medical Systems Information Technologies, Inc.MWI
Z-3037-2026Class IIPORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592GE Medical Systems Information Technologies, Inc.MWI
Z-3036-2026Class IIPORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209GE Medical Systems Information Technologies, Inc.MWI
Z-2967-2026Class IIParagonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF#...Paragonix Technologies Inc.KDN
Z-3013-2026Class IIMidmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version...Midmark CorpDRG
Z-3012-2026Class IIMidmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version...Midmark CorpDPS
Z-2954-2026Class IIDentsply Sirona Capsule Mixer Model No. 5546068Sdi Ltd.EFD
Z-3328-2026Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High...Spectrum Medical SrlDTR
Z-3327-2026Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High...Spectrum Medical SrlDTR
Z-2927-2026Class IIThermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901...Remel Europe Ltd.GTJ
Z-3330-2026Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS...Tandem Diabetes Care, Inc.QFG
Z-2877-2026Class IIFilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The...BioFire Defense, LLCPRD
Z-2935-2026Class IIStraumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim...Straumann USA, LLCDZE
Z-2932-2026Class IIPhilips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235...Philips Medical Systems Nederland B.V.OWB
Z-2931-2026Class IIPhilips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079...Philips Medical Systems Nederland B.V.OWB
Z-3211-2026Class IIReign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907...F & A FoundationJDR
Z-2979-2026Class IBMC/REACTHEALTH Luna G3 APAP REF LG 3600BMC Medical Co., Ltd.MNS
Z-2974-2026Class IIBeckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower...Siemens Healthcare Diagnostics Inc.JJE
Z-2973-2026Class IIBeckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower...Siemens Healthcare Diagnostics Inc.JJE
Z-3108-2026Class IHalyard IV START KIT NON-STERILE REF: KRIV26-02AVID Medical, Inc.LRO
Z-3093-2026Class IICitrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers...Fresenius Medical Care Renal Therapies Group, LLCKPO
Z-3092-2026Class IINaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers...Fresenius Medical Care Renal Therapies Group, LLCKPO
Z-3091-2026Class IIGRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid...Fresenius Medical Care Renal Therapies Group, LLCKPO
Z-3109-2026Class IIHalyard IV Start Kit Non-Sterile REF: KRIV26-02AVID Medical, Inc.LRO
Z-3018-2026Class IICONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF#...ConMed CorporationMAI
Z-2998-2026Class IIOnli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli...Hollister ULCGBM
Z-2962-2026Class IISuture Cinch Long 1pk. Endoscopic tissue approximation device.Boston Scientific CorporationOCW
Z-2961-2026Class IIOverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.Boston Scientific CorporationOCW
Z-2949-2026Class IICardinal Health Presource Kits: 1) BASIC PACK , Catalog Number...Medtronic, Inc.OJK
Z-2948-2026Class IICardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number...Medtronic, Inc.OJH
Z-2947-2026Class IICardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number...Medtronic, Inc.OJG
Z-2946-2026Class IICardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number...Medtronic, Inc.OJA
Z-2945-2026Class IICardinal Health Presource Kits: 1) ENT TRAY , Catalog Number...Medtronic, Inc.OGR
Z-2944-2026Class IICardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMBMedtronic, Inc.OEZ
Z-2943-2026Class IICardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number...Medtronic, Inc.OFQ
Z-2942-2026Class IICardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number...Medtronic, Inc.LRO
Z-2970-2026Class IIBlanketrol III, Model 233; Thermal regulating system.Gentherm Medical, LLCDWJ
Z-2969-2026Class IIInnercool Coolblue Console, Model STx; Thermal regulating system.Gentherm Medical, LLCDWJ
Z-2968-2026Class IIBlanketrol II Model 222S; Thermal regulating system.Gentherm Medical, LLCDWJ
Z-2966-2026Class IISiemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085...Siemens Healthcare Diagnostics Products LimitedLIP
Z-2965-2026Class IISiemens Healthineers Immulite 2000 Systems SYP Syphilis...Siemens Healthcare Diagnostics Products LimitedLIP
Z-2976-2026Class IIBeckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13...Siemens Healthcare Diagnostics Inc.LBZ
Z-2975-2026Class IISyva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mLSiemens Healthcare Diagnostics Inc.LBZ
Z-2982-2026Class IIMiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLWMedtronic, Inc.QFG
Z-2981-2026Class IIMiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;Medtronic, Inc.OZP
Z-2933-2026Class IIOBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF...OBP Medical CorporationHIB