510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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

59,544 records, page 594 of 1191
FDA device recalls, page 594 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0318-2018Class IIHIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part...Repro-Med Systems, Inc.FPA
Z-0317-2018Class IIFreedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275...Repro-Med Systems, Inc.FRN
Z-1557-2016Class IIeCareCoordinator allows the customer to schedule patient tasks (i.e., take weight...Visicu, Inc.DRG
Z-1604-2016Class IIPoly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains...Ferno-Washington IncNZD
Z-1603-2016Class IIPoly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit...Ferno-Washington IncNZD
Z-1576-2016Class IIDrew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L...JAS Diagnostics/Drew ScientificGKZ
Z-1500-2016Class IIADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560...Siemens Healthcare Diagnostics Inc.GKZ
Z-1325-2016Class IIFresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-1624-2016Class IIHamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001...Hamilton Medical AGCBK
Z-1575-2016Class IIPanorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can...Datascope Corp.MHX
Z-1318-2016Class IIAll instrumentation associated with the Prelude PF Resurfacing Knee System.Zimmer GmbHKRR
Z-1916-2016Class IILiko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH...Hill-Rom Inc.FSA
Z-1618-2016Class IISyva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the...Siemens Healthcare Diagnostics Inc.LAO
Z-1369-2016Class IIDiana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an...Abbott MedicalNEP
Z-1368-2016Class IIDiana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000...Abbott MedicalNEP
Z-1367-2016Class IIDiana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Diana is an...Abbott MedicalNEP
Z-1366-2016Class IIDiana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Diana is an...Abbott MedicalNEP
Z-1365-2016Class IIDiana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST...Abbott MedicalNEP
Z-1364-2016Class IIDiana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an...Abbott MedicalNEP
Z-1268-2016Class IIHelios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended...KaVo Dental Technologies, LLCEAZ
Z-1867-2016Class IIIntegra MicroFrance Monopolar and Bipolar Electrosurgical InstrumentsIntegra LifeSciences CorporationGEI
Z-1866-2016Class IIIntegra MicroFrance Monopolar and Bipolar Electrosurgical InstrumentsIntegra LifeSciences CorporationGEI
Z-1670-2016Class IIADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in...Siemens Healthcare Diagnostics Inc.CDT
Z-1309-2016Class IIMRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System...Viewray Systems, Inc.IYE
Z-1308-2016Class IIVERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear...Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery WorkIYE
Z-1277-2016Class IIEstradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL...Roche Diagnostics GmbHCHP
Z-1276-2016Class IIEstradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9...Roche Diagnostics GmbHCHP
Z-1506-2016Class IIIntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems...Philips North America LLCJAK
Z-1505-2016Class IIExtended Brilliance Workspace NM Special Nuclear medicine image display and processing...Philips North America LLCKPS
Z-1504-2016Class IIExtended Brilliance Workspace NM Nuclear medicine image display and processing...Philips North America LLCKPS
Z-1275-2016Class IGuardian II Hemostasis Valve, models 8210 and 8211. The following models are only...Vascular Solutions LLCDTL
Z-1395-2016Class IIBARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is...C.R. Bard IncDWJ
Z-1267-2016Class IIThe Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and...Implant Direct Sybron Manufacturing LLCDZE
Z-1578-2016Class IIHand-Held Scanner USB IT3800 For sample identification and tracking when used with...Roche Molecular Systems IncJJH
Z-2050-2016Class IIBigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38Circulatory Technology, Inc.DTN
Z-2057-2016Class IIdynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile...Dynarex Corp.NNI
Z-1321-2016Class IITOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01...ArthroCare CorporationGEI
Z-1859-2016Class IIVistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321Medtronic, Inc.LRS
Z-1858-2016Class IIVistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319Medtronic, Inc.LRS
Z-1857-2016Class IICurity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 cm x 91.4...Medtronic, Inc.LRS
Z-1856-2016Class IICurity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7...Medtronic, Inc.LRS
Z-1855-2016Class IICurity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5...Medtronic, Inc.LRS
Z-1854-2016Class IICurity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7...Medtronic, Inc.LRS
Z-1853-2016Class IICurity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item...Medtronic, Inc.LRS
Z-1852-2016Class IICurity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item...Medtronic, Inc.LRS
Z-1851-2016Class IIKerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item...Medtronic, Inc.LRS
Z-1850-2016Class IIKerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item...Medtronic, Inc.LRS
Z-1849-2016Class IICurity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2...Medtronic, Inc.LRS
Z-1848-2016Class IIKerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2...Medtronic, Inc.LRS
Z-1847-2016Class IICurity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch...Medtronic, Inc.LRS