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 100 of 1190
FDA device recalls, page 100 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0768-2025Class IIBodor P and C series laser cutting machinesJinan Bodor Cnc Machine Co LtdRFE
Z-1006-2025Class IIBrand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number...Ortho-Clinical Diagnostics, Inc.JJE
Z-1005-2025Class IIBrand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number...Ortho-Clinical Diagnostics, Inc.JJE
Z-1063-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE...Karl Storz Endoscopy-America, Inc.FGB
Z-1062-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE...Karl Storz Endoscopy-America, Inc.FGB
Z-1061-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6, 34 cm, NON STERILE, RxONLY...Karl Storz Endoscopy-America, Inc.FGB
Z-1060-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE...Karl Storz Endoscopy-America, Inc.FGB
Z-1059-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6, 43 cm, NON STERILE...Karl Storz Endoscopy-America, Inc.FGB
Z-1058-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6, 43cm, NON STERILE...Karl Storz Endoscopy-America, Inc.FGB
Z-1057-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6, 43 cm, NON STERILE...Karl Storz Endoscopy-America, Inc.FGB
Z-1056-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6, 43 cm, NON STERILE...Karl Storz Endoscopy-America, Inc.FGB
Z-1055-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY...Karl Storz Endoscopy-America, Inc.FGB
Z-1054-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE...Karl Storz Endoscopy-America, Inc.FGB
Z-1053-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CEKarl Storz Endoscopy-America, Inc.FGB
Z-1052-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CEKarl Storz Endoscopy-America, Inc.FGB
Z-1051-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY...Karl Storz Endoscopy-America, Inc.FGB
Z-1004-2025Class IIBD PCR Cartridges used with MAX System. Model Number: 437519Becton Dickinson & CoNJR
Z-0837-2025Class IIKarl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CEKarl Storz Endoscopy-America, Inc.LRC
Z-0924-2025Class II8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci...Intuitive Surgical, Inc.NAY
Z-0923-2025Class II8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical...Intuitive Surgical, Inc.NAY
Z-0847-2025Class II8Mm, Monopolar Curved Scissors, Is4000 Ref 470179Intuitive Surgical, Inc.NAY
Z-0900-2025Class IIGE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085...GE Medical Systems Israel, Functional ImagingKPS
Z-0899-2025Class IIGE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3)...GE Medical Systems Israel, Functional ImagingKPS
Z-0898-2025Class IIGE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3)...GE Medical Systems Israel, Functional ImagingKPS
Z-0897-2025Class IIGE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System...GE Medical Systems Israel, Functional ImagingKPS
Z-0896-2025Class IIGE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography...GE Medical Systems Israel, Functional ImagingKPS
Z-0895-2025Class IIGE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System...GE Medical Systems Israel, Functional ImagingKPS
Z-0894-2025Class IIGE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System...GE Medical Systems Israel, Functional ImagingKPS
Z-0893-2025Class IIGE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2)...GE Medical Systems Israel, Functional ImagingKPS
Z-0892-2025Class IIGE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2)...GE Medical Systems Israel, Functional ImagingKPS
Z-0891-2025Class IIGE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2)...GE Medical Systems Israel, Functional ImagingKPS
Z-0890-2025Class IIGE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF...GE Medical Systems Israel, Functional ImagingKPS
Z-0889-2025Class IIGE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3)...GE Medical Systems Israel, Functional ImagingKPS
Z-0888-2025Class IIGE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM...GE Medical Systems Israel, Functional ImagingKPS
Z-1020-2025Class IIHemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnosticInstrumentation Laboratory Co.KFF
Z-0846-2025Class IIStryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use...Tornier S.A.S.OLO
Z-0766-2025Class IIEMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert...Encore Medical, LPJWH
Z-0905-2025Class IOlympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891...OLYMPUS Corporation of the AmericasFBN
Z-0708-2025Class IMonitoring Service Application (MSA). Software to process, analyze, display, and report...Braemar Manufacturing, LLCDPS
Z-1199-2025Class IIHot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF...Augustine Temperature Management, LLCDWJ
Z-1198-2025Class IIHot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF...Augustine Temperature Management, LLCDWJ
Z-1197-2025Class IIHot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF...Augustine Temperature Management, LLCDWJ
Z-0979-2025Class IICODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number...Integra LifeSciences CorporationJXG
Z-0765-2025Class IMedline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-0764-2025Class IMedline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item...MEDLINE INDUSTRIES, LP - NorthfieldFPA
Z-0978-2025Class IICODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number...Integra LifeSciences CorporationJXG
Z-0977-2025Class IICODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number...Integra LifeSciences CorporationJXG
Z-0962-2025Class IILithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single...OLYMPUS Corporation of the AmericasLQC
Z-1065-2025Class IICalibrate CCX Interbody System for spinal fusion procedures: Implants: (1)...Alphatec Spine, Inc.MAX
Z-1016-2025Class IIBrand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog...Trinity Sterile, Inc.OXQ