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 175 of 1190
FDA device recalls, page 175 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0489-2024Class IIvyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A...Jaeger Medical GmbHLSZ
Z-0488-2024Class IIvyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A...Jaeger Medical GmbHLSZ
Z-0524-2024Class IIPHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610Limacorporate S.p.A.JWH
Z-0609-2024Class IIRAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro...Siemens Healthcare Diagnostics Inc.JIX
Z-0608-2024Class IIRAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro...Siemens Healthcare Diagnostics Inc.JIX
Z-0607-2024Class IIRAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro...Siemens Healthcare Diagnostics Inc.JIX
Z-0606-2024Class IIRAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro...Siemens Healthcare Diagnostics Inc.JIX
Z-0738-2024Class IIINDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040Phase Scientific International LimitedQMN
Z-0641-2024Class IICD11b APC: ASR, REF: 340936, and CE, REF: 333143Becton, Dickinson and Company, BD BiosciencesMVU
Z-0518-2024Class IIIconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix...Riverpoint Medical, LLCMBI
Z-0510-2024Class IIVITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry...Ortho-Clinical Diagnostics, Inc.KHS
Z-0447-2024Class IIELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy...Elekta LimitedIYE
Z-0446-2024Class IIELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical...Elekta LimitedIYE
Z-0445-2024Class IIELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy...Elekta LimitedIYE
Z-0444-2024Class IIELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle...Elekta LimitedIYE
Z-0443-2024Class IIELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation...Elekta LimitedIYE
Z-0442-2024Class IIELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical...Elekta LimitedIYE
Z-1192-2024Class IIGRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95...Graphenano Dental, SLEBI
Z-0619-2024Class IIILiberty Select Cycler, Model numbers RTLR180343 and RTLR180111Fresenius Medical Care Renal Therapies Group, LLCFKX
Z-0575-2024Class IIInjection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF...Karl Storz Endoscopy-America, Inc.CCW
Z-0574-2024Class IIInjection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80...Karl Storz Endoscopy-America, Inc.LRC
Z-0573-2024Class IIInjection Needle, LUER-lock,0.8mm, REF: 26175PDKarl Storz Endoscopy-America, Inc.HET
Z-0572-2024Class IIInjection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182AKarl Storz Endoscopy-America, Inc.FBK
Z-0566-2024Class IICardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16ACardioQuipDWC
Z-0565-2024Class IICardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16ACardioQuipDWC
Z-0571-2024Class IIInjection Needle, REF: 25207Karl Storz Endoscopy-America, Inc.GCF
Z-0395-2024Class IISmartPath to dStream for 1.5TPhilips North America LLCLNH
Z-0394-2024Class IIIntera 1.5T Power/PulsarPhilips North America LLCLNH
Z-0393-2024Class IIIntera 1.5TPhilips North America LLCLNH
Z-0392-2024Class IIIngenia 1.5T CXPhilips North America LLCLNH
Z-0391-2024Class IIAchieva 1.5T Initial SystemPhilips North America LLCLNH
Z-0390-2024Class IIAchieva 1.5T ConversionPhilips North America LLCLNH
Z-0389-2024Class IIAchieva 1.5TPhilips North America LLCLNH
Z-0356-2024Class IIstryker Sage PrimaFit External Urine Management System for the Female AnatomySage Products LLCNZU
Z-0601-2024Class IIepoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475...Siemens Healthcare Diagnostics Inc.CHL
Z-0499-2024Class IICombo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or...Integra LifeSciences CorporationHBG
Z-0498-2024Class IIIntegra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles...Integra LifeSciences CorporationHBG
Z-0497-2024Class IIIntegra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles...Integra LifeSciences CorporationHBG
Z-0496-2024Class IIIntegra Cranial Access Kit- For access to the subarachnoid space or the lateral...Integra LifeSciences CorporationHBG
Z-0495-2024Class IIIntegra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles...Integra LifeSciences CorporationHBG
Z-0494-2024Class IIIntegra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles...Integra LifeSciences CorporationHBG
Z-0493-2024Class IIIntegra Cranial Access Kit - For access to the subarachnoid space or the lateral...Integra LifeSciences CorporationHBG
Z-0492-2024Class IIIntegra Cranial Access Kit -For access to the subarachnoid space or the lateral...Integra LifeSciences CorporationHBG
Z-0491-2024Class IIIntegra Cranial access kit (without Prep solutions) Bit and Guard-For access to the...Integra LifeSciences CorporationHBG
Z-0682-2024Class IIARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The...Abbott MedicalJJE
Z-0681-2024Class IIAlinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully...Abbott MedicalJJE
Z-0680-2024Class IIAlinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully...Abbott MedicalJJE
Z-0521-2024Class IICardinal Health Clean Stool Transportation System-For the collection, transportation...Meridian Bioscience IncFMH
Z-0520-2024Class IIPara-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation...Meridian Bioscience IncIGG
Z-0519-2024Class IIPara-Pak Clean Vial-For the collection, transportation, preservation, and examination of...Meridian Bioscience IncFMH