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 4 of 1187
FDA device recalls, page 4 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3081-2026Class IILUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS...Boston Scientific CorporationMXD
Z-3136-2026Class IICitric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)Nipro Renal Soultions USA, CorporationKPO
Z-3135-2026Class IICitric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25Nipro Renal Soultions USA, CorporationKPO
Z-3134-2026Class IIMedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))Nipro Renal Soultions USA, CorporationKPO
Z-3133-2026Class IIMedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201Nipro Renal Soultions USA, CorporationKPO
Z-3174-2026Class IIBrand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number...Ptw FreiburgIYE
Z-3089-2026Class IIBrand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number...B Braun Medical IncFPA
Z-3014-2026Class IIAlphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital...Canon Medical Systems USA, Inc.OWB
Z-3257-2026Class IIBrand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number...Baxter Healthcare CorporationNHJ
Z-3259-2026Class IINew York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2...New York Embroidery Studio, Inc.OEA
Z-3147-2026Class IIMEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog...Bayer Medical Care, Inc.DXT
Z-3172-2026Class IISunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25Well Lead Medical Co. LtdBTR
Z-3210-2026Class IIConvenience kits CATARACT PACK DYNJ59881AMedline Industries, LPOJK
Z-3209-2026Class IIConvenience kits MYRINGOTOMY PACK-LF DYNJ59097AMedline Industries, LPLRO
Z-3146-2026Class IIPercutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA)...Maquet Cardiopulmonary GmbhDWF
Z-3145-2026Class IIPercutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA)...Maquet Cardiopulmonary GmbhDWF
Z-3144-2026Class IIPercutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA)...Maquet Cardiopulmonary GmbhDWF
Z-3208-2026Class IIConvenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734FMedline Industries, LPFDE
Z-3207-2026Class IIConvenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925AMedline Industries, LPOFT
Z-3171-2026Class IICore Services Hub V8, a set of backend services including Cross Enterprise (XE) and...GE HealthcareLLZ
Z-3170-2026Class IIWorkflow Core Services V8, intended to provide set of services for storage and retrieval...GE HealthcareLLZ
Z-3169-2026Class IICentricity PACS Server V7, intended for managing digital medical images and associated...GE HealthcareLLZ
Z-3168-2026Class IICentricity PACS V2, V3, V4, V6, V7, software product is intended for the storage...GE HealthcareLLZ
Z-3167-2026Class IIEnterprise Archive V8, software product for receiving, archiving, and sending electronic...GE HealthcareLLZ
Z-3166-2026Class IICentricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving...GE HealthcareLLZ
Z-3142-2026Class IIPhilips PIC iX Essentials REF:867093Philips North AmericaMHX
Z-3141-2026Class IIPhilips Patient Information Center iX REF:866389Philips North AmericaMHX
Z-3064-2026Class IIHEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN)...Advanced Medical Optics, Inc.LZP
Z-3192-2026Class IIEt Control, Software option for anesthesia gas machine to achieve and maintain targeted...Datex-Ohmeda, Inc.BSZ
Z-3191-2026Class IIAisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000Datex-Ohmeda, Inc.BSZ
Z-3190-2026Class IIAisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000Datex-Ohmeda, Inc.BSZ
Z-3189-2026Class IIAisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000Datex-Ohmeda, Inc.BSZ
Z-3143-2026Class IICarescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04...GE Medical Systems Information Technologies IncDQK
Z-3206-2026Class IISCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME...Howmedica Osteonics Corp.NPJ
Z-3205-2026Class IISCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM...Howmedica Osteonics Corp.N/A
Z-3204-2026Class IITRIDENT 0 POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured...Howmedica Osteonics Corp.MEH
Z-3203-2026Class IISCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orth...Howmedica Osteonics Corp.MBH
Z-3202-2026Class IIBEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640...Howmedica Osteonics Corp.LGE
Z-3201-2026Class IIACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY...Howmedica Osteonics Corp.KWZ
Z-3200-2026Class IIDURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE...Howmedica Osteonics Corp.KWS
Z-3199-2026Class IIABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT...Howmedica Osteonics Corp.KWL
Z-3198-2026Class IITRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4...Howmedica Osteonics Corp.KRO
Z-3197-2026Class IIALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-091...Howmedica Osteonics Corp.JWH
Z-3196-2026Class IIOMNIFIT SERIES I ACET. INSERT 10 22mm ID Catalog No. 2001-2246 Orthopaedic implant...Howmedica Osteonics Corp.JDL
Z-3195-2026Class IIAXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant...Howmedica Osteonics Corp.JDC
Z-2872-2026Class IBD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered...Bard Access Systems, Inc.FMI
Z-3225-2026Class IICombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer...Fresenius Medical Care Renal Therapies Group, LLCFJK
Z-3138-2026Class IIAMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394BWindstone Medical Packaging, Inc.KDD
Z-3132-2026Class IStatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.Nova Biomedical CorporationPZI
Z-3131-2026Class IStatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.Nova Biomedical CorporationPZI