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 70 of 1190
FDA device recalls, page 70 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2417-2025Class IIBrand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version...Thor Photomedicine Inc.ILY
Z-2416-2025Class IIBrand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version...Thor Photomedicine Inc.ILY
Z-2450-2025Class IBrand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+...Dexcom, Inc.QBJ
Z-2449-2025Class IBrand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+...Dexcom, Inc.QBJ
Z-2448-2025Class IBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM...Dexcom, Inc.QBJ
Z-2447-2025Class IBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM...Dexcom, Inc.QBJ
Z-2446-2025Class IBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM...Dexcom, Inc.QBJ
Z-2479-2025Class IIMedline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-2486-2025Class IIRefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)008600039...Reflexion Medical, Inc.QVA
Z-2344-2025Class IIOtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including...Lumenis LtdGEX
Z-2292-2025Class IIBartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic...Trinity Biotech USAMJH
Z-2499-2025Class IILIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911...Physio Control, Inc.MKJ
Z-2498-2025Class IILIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 /...Physio Control, Inc.MKJ
Z-2497-2025Class IILIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 /...Physio Control, Inc.MKJ
Z-1704-2026Class IIBrand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon...Summa Therapeutics, LLCLIT
Z-2528-2025Class IIBrand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog...B Braun Medical IncLJT
Z-2476-2025Class IISTA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended...Diagnostica Stago, Inc.KQJ
Z-2475-2025Class IISTA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are...Diagnostica Stago, Inc.KFF
Z-2474-2025Class IISTA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are...Diagnostica Stago, Inc.KFF
Z-2473-2025Class IISTA Satellite. Product Code: All references. All software versions. The STA Satellite is...Diagnostica Stago, Inc.JPA
Z-2343-2025Class IBattery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF...Tandem Diabetes Care, Inc.QFG
Z-2298-2025Class IIBrand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog...Insightra Medical IncDSP
Z-2549-2025Class IIBrand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog...Encore Medical, LPFSM
Z-2548-2025Class IIBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER...Encore Medical, LPKWS
Z-2547-2025Class IIBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL...Encore Medical, LPKWS
Z-2546-2025Class IIBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER...Encore Medical, LPKWS
Z-2591-2025Class IISureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216C.R. Bard IncMJC
Z-2590-2025Class IISureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter...C.R. Bard IncMJC
Z-2552-2025Class IIBrand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay...Quest International, Inc.PCL
Z-2520-2025Class IIOrthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06...O&M Halyard, Inc.KKX
Z-2239-2025Class IIPinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System SoftwarePhilips North America LLCMUJ
Z-2589-2025Class IISureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter...C.R. Bard IncMJC
Z-2461-2025Class IIIPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC...Medtronic Xomed, Inc.HBE
Z-2516-2025Class IITOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS...Premia Spine Ltd.QWK
Z-2345-2025Class IIDynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an...Dynex Technologies, Inc.LXG
Z-2329-2025Class IIPentax Medical Video Processor; Model Number: EPK-i8020c;PENTAX of America, Inc.PEA
Z-2620-2025Class IIChromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF...STRYKER Communications, Inc.FSY
Z-2289-2025Class IIPlastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.Waldemar Link GmbH & Co. KGJDG
Z-2288-2025Class IIProsthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.Waldemar Link GmbH & Co. KGJDG
Z-2472-2025Class IIAMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP...American Contract Systems, Inc.OJH
Z-2471-2025Class IIAMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST...American Contract Systems, Inc.OJF
Z-2470-2025Class IIAMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY...American Contract Systems, Inc.OHD
Z-2469-2025Class IIAMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON...American Contract Systems, Inc.MLS
Z-2468-2025Class IIAMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI...American Contract Systems, Inc.OJG
Z-2467-2025Class IIAMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C...American Contract Systems, Inc.LRO
Z-2466-2025Class IIAMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO...American Contract Systems, Inc.NWU
Z-2465-2025Class IIAMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE...American Contract Systems, Inc.FDE
Z-2464-2025Class IIAMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK...American Contract Systems, Inc.OEZ
Z-2460-2025Class IMedline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic...MEDLINE INDUSTRIES, LP - NorthfieldNLH
Z-2415-2025Class IISpectrum IQ Infusion Pump, Product Code 3570009Baxter Healthcare CorporationFRN