510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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

59,486 records, page 755 of 1190
FDA device recalls, page 755 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1327-2013Class IIFluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a...Hologic, Inc.JAA
Z-1326-2013Class IIFluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini...Hologic, Inc.JAA
Z-1532-2013Class IIembla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort...Embla System LLCMNR
Z-1511-2013Class IIFLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT...Cordis US Corp.NIP
Z-1510-2013Class IIFLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT...Cordis US Corp.NIP
Z-1509-2013Class IIFLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary...Cordis US Corp.FGE
Z-1508-2013Class IIFLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT...Cordis US Corp.NIP
Z-1507-2013Class IIFLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary...Cordis US Corp.FGE
Z-1437-2013Class IIFisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models...Fisher & Paykel Healthcare, Inc.BZD
Z-0598-2016Class IBrainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic...Brainlab, Inc.HAW
Z-0626-2014Class IIHbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the...Siemens Healthcare Diagnostics Inc.LCP
Z-0625-2014Class IIHB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the...Siemens Healthcare Diagnostics Inc.LCP
Z-1180-2013Class IISTERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological...Advanced Sterilization ProductsFRC
Z-1947-2013Class II1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual...Medtronic, Inc.BTM
Z-1958-2013Class IICase Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid...SPINEFRONTIER, Inc. dba LESspine InnovationsFSM
Z-1536-2013Class II90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The...Orthopediatrics CorpHWC
Z-1535-2013Class II90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The...Orthopediatrics CorpHWC
Z-1534-2013Class II90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The...Orthopediatrics CorpHWC
Z-0833-2015Class IICentricity Enterprise Archive is a software product for receiving, archiving and sending...GE HealthcareLMB
Z-1440-2013Class IIZeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C...Carl Zeiss Meditec IncEPT
Z-2243-2013Class IISynthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S...Synthes GmbHHTY
Z-1275-2013Class IZilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product...Cook IncorporatedNIU
Z-1274-2013Class IZilver PTX Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product...Cook IncorporatedNIU
Z-2232-2014Class IIVIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the...bioMerieux, Inc.DAP
Z-1667-2013Class ITracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide...Bryan Medical IncBTO
Z-1506-2013Class IIThe Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and...Alcon Grieshaber AGHQE
Z-2167-2013Class IIXlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number...Xlumena, Inc.GCJ
Z-1400-2013Class IISynchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number...Siemens Healthcare Diagnostics Inc.KHP
Z-2134-2013Class IICONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal...DePuy Spine, Inc.NDN
Z-2133-2013Class IICONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE...DePuy Spine, Inc.NDN
Z-2132-2013Class IICONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal...DePuy Spine, Inc.NDN
Z-1401-2013Class IIAlere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo...Alere San Diego, Inc.JHI
Z-1524-2013Class IIBARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to...Bard Peripheral Vascular IncFZP
Z-0811-2014Class II1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated...Ziemer USA IncHQF
Z-1646-2013Class IIComputed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core...Philips North America LLCJAK
Z-1586-2013Class IIDC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor...Medrad, Inc.MWI
Z-1466-2013Class IIHill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to...Hill-Rom Inc.FNL
Z-0615-2014Class IISynthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric...Synthes GmbHHWE
Z-1330-2013Class IIILiquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is...Bio-Rad Laboratories Inc.JJY
Z-1278-2013Class IIDePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy...DePuy Mitek, Inc.NBH
Z-1273-2013Class IICypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use...Cypress Medical Products LLCHFW
Z-1245-2013Class IFreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use...Abbott MedicalNBW
Z-1777-2013Class IILIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk...Ethicon Endo-Surgery IncGDO
Z-1776-2013Class IILIGACLIP Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L...Ethicon Endo-Surgery IncGDO
Z-1775-2013Class IILIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The...Ethicon Endo-Surgery IncGDO
Z-1735-2013Class IIVarious types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic...Paa Laboratories IncKIS
Z-1364-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push Button...Progressive Medical IncGEI
Z-1363-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic...Progressive Medical IncGEI
Z-1362-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY...Progressive Medical IncGEI
Z-1361-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY...Progressive Medical IncGEI