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 16 of 1187
FDA device recalls, page 16 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2826-2026Class IIBrand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number...Instrumentation Laboratory Co.CHL
Z-2825-2026Class IIBrand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number...Instrumentation Laboratory Co.CHL
Z-2824-2026Class IIBrand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number...Instrumentation Laboratory Co.CHL
Z-2823-2026Class IIBrand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number...Instrumentation Laboratory Co.CHL
Z-2822-2026Class IIBrand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with...Instrumentation Laboratory Co.CHL
Z-2716-2026Class IITMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking...Think Surgical Inc.OLO
Z-2821-2026Class IIBrand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number...Instrumentation Laboratory Co.CHL
Z-2553-2026Class IIGE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing SystemGE Medical Systems SCSLLZ
Z-2359-2026Class IPanda Freestanding Warmer, Infant Radiant Warmer Product Identifiers...GE HealthcareFMT
Z-2358-2026Class IGiraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated...GE HealthcareFMT
Z-2357-2026Class IGiraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator...GE HealthcareBTM
Z-2459-2026Class IIRitmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995CAMD Medicom Inc.EFQ
Z-2458-2026Class IIRitmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C...AMD Medicom Inc.EFQ
Z-2525-2026Class IIVOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001Ventec Life Systems, Inc.CBK
Z-2517-2026Class IISplashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI...Merit Medical Systems, Inc.DQX
Z-2763-2026Class IIHalyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305OJK
Z-2398-2026Class IISiemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795...Siemens Healthcare Diagnostics Inc.MLM
Z-2639-2026Class IIBrand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling...Teleflex MedicalEFQ
Z-2767-2026Class II3mensio Workstation (Vascular Fenestrated) softwarePIE Medical Imaging B.V.QIH
Z-2208-2026Class IAtlan A350XL. Model Number: 8621600. anesthesia workstationDraeger, Inc.BSZ
Z-2207-2026Class IAtlan A350. Model Number: 8211500. anesthesia workstationDraeger, Inc.BSZ
Z-2401-2026Class IIBicarby Dialysate; Model number: RFP-400-G;Fresenius Medical Care Renal Therapies Group, LLCKPO
Z-3253-2026Class IInGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT...Criticare Technologies, Inc.MHX
Z-2455-2026Class IMedline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2)...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2454-2026Class IMedline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-2453-2026Class IMedline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2452-2026Class IMedline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2)...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-2224-2026Class IIvenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004Fresenius Kabi USA, LLCFRN
Z-2223-2026Class ILVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.Fresenius Kabi USA, LLCFRN
Z-2282-2026Class IINeptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune...Stryker Corp.JCX
Z-2278-2026Class IDesign Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material...B Braun Medical IncOFU
Z-2277-2026Class ISpinocan Spinal Needle procedure kits: Material Description (Material Number)...B Braun Medical IncOFU
Z-2276-2026Class ISpinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN...B Braun Medical IncOFU
Z-2554-2026Class IIThuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.IPG Medical CorporationGEX
Z-2721-2026Class IIOlympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.OLYMPUS Corporation of the AmericasKQT
Z-2720-2026Class IIOlympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model...OLYMPUS Corporation of the AmericasKQT
Z-2719-2026Class IIOlympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.OLYMPUS Corporation of the AmericasKQT
Z-2718-2026Class IIOlympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.OLYMPUS Corporation of the AmericasKQT
Z-2508-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-2507-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-2506-2026Class IIMEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD...MEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-2505-2026Class IIMEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C...MEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-2504-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-2503-2026Class IIMEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-2502-2026Class IIMEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU...MEDLINE INDUSTRIES, LP - NorthfieldMLT
Z-2501-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-2500-2026Class IIMEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-2499-2026Class IIMEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044MEDLINE INDUSTRIES, LP - NorthfieldNSB
Z-2498-2026Class IIMEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU DYNJ68808MEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-2497-2026Class IIMEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy...MEDLINE INDUSTRIES, LP - NorthfieldLRO