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 572 of 1191
FDA device recalls, page 572 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2704-2016Class IIADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry...Siemens Healthcare Diagnostics Inc.LCP
Z-2658-2016Class IIIngenuity Core128, Model number 728323 Product Usage: Computed Tomography X-ray systems...Philips North America LLCJAK
Z-2657-2016Class IIIngenuity Core, Model number 728321 Product Usage: Computed Tomography X-ray systems...Philips North America LLCJAK
Z-2656-2016Class IIBrilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomography X-ray...Philips North America LLCJAK
Z-2655-2016Class IIBrilliance 16, Model number 728246 Product Usage: Computed Tomography X-ray systems...Philips North America LLCJAK
Z-2654-2016Class IIBrilliance BigBore Radiology CT Model number 728244 Product Usage: Computed Tomography...Philips North America LLCJAK
Z-2653-2016Class IIBrilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomography...Philips North America LLCJAK
Z-2652-2016Class IIBrilliance 64 CT Model number 728231 Product Usage: Computed Tomography X-ray systems...Philips North America LLCJAK
Z-2387-2016Class IIIntegra External Fixation System Slotted Post - Small Catalogue #12224228; Integra...Integra LifeSciences CorporationKTT
Z-2375-2016Class IIInstructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use...Nobel Biocare USA LLCDZI
Z-2386-2016Class IIIntegra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue...Integra LifeSciences CorporationKTT
Z-2775-2016Class IIEndura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0...Thermo Finnigan LLCDOP
Z-2603-2016Class IITIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030Novus Scientific ABFTL
Z-2745-2016Class IISmith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during...Smith & Nephew, Inc.MAI
Z-2307-2016Class IIMultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036Philips North America LLCIZI
Z-2306-2016Class IIUroDiagnost; x-ray system. Product Code: 708033Philips North America LLCIXR
Z-2305-2016Class IIMultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037...Philips North America LLCIZI
Z-2717-2016Class IINOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System...KaVo Dental Technologies, LLCEHD
Z-2716-2016Class IINOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray...KaVo Dental Technologies, LLCEHD
Z-2638-2016Class IITIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics...Medtronic Sofamor Danek USA IncJWH
Z-2637-2016Class IITIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics...Medtronic Sofamor Danek USA IncJWH
Z-2636-2016Class IITIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacementMedtronic Sofamor Danek USA IncJWH
Z-2635-2016Class IITIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .Medtronic Sofamor Danek USA IncJWH
Z-2634-2016Class IIRESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF...Medtronic Sofamor Danek USA IncJWH
Z-2633-2016Class IIRESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF...Medtronic Sofamor Danek USA IncJWH
Z-2632-2016Class IIRESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF...Medtronic Sofamor Danek USA IncJWH
Z-2631-2016Class IIResponsive, Knee: Femoral Component Cr/cs, Size 3R, Ref 90-Srk-311300, Qty: 1, Sterile...Medtronic Sofamor Danek USA IncJWH
Z-2548-2016Class IIXpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay...CepheidNQX
Z-2649-2016Class IIBVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of...Apyx Medical CorporationGEI
Z-2648-2016Class IIBVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of...Apyx Medical CorporationGEI
Z-2647-2016Class IIBVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of...Apyx Medical CorporationGEI
Z-2646-2016Class IIBVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of...Apyx Medical CorporationGEI
Z-2378-2016Class IIIBD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states...Becton, Dickinson and Company, BD BiosciencesGKZ
Z-2319-2016Class IIMACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU...Medtronic Navigation, IncHAW
Z-2318-2016Class IIMACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in...Medtronic Navigation, IncHAW
Z-2317-2016Class IIFusion ENT Application. The software application is sent in CD format with an IFU...Medtronic Navigation, IncHAW
Z-2316-2016Class IISynergy Spine. The software application is sent in CD format with an IFU, wrapped in...Medtronic Navigation, IncOLO
Z-2315-2016Class IIS7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in...Medtronic Navigation, IncHAW
Z-2314-2016Class IIFrameLink. The software application is sent in CD format with an IFU, wrapped in plastic...Medtronic Navigation, IncDZE
Z-2313-2016Class IISynergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in...Medtronic Navigation, IncHAW
Z-0577-2018Class IICustom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed...Abbott MedicalJOH
Z-0110-2017Class IIcobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512...Roche Diagnostics GmbHMKT
Z-0109-2017Class IIcobas p 312 Pre-Analytical System calculator/data processing module, for clinical...Roche Diagnostics GmbHJQP
Z-0108-2017Class IIcobas p 471 centrifuge unit calculator/data processing module, for clinical use Product...Roche Diagnostics GmbHJQP
Z-0107-2017Class IIcobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical...Roche Diagnostics GmbHJQP
Z-0106-2017Class IIcobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical...Roche Diagnostics GmbHJQP
Z-0105-2017Class IIRSD 800 Sorting System calculator/data processing module, for clinical use Product...Roche Diagnostics GmbHJQP
Z-0104-2017Class IIRSD 800A Aliquoting System calculator/data processing module, for clinical use Product...Roche Diagnostics GmbHJQP
Z-0103-2017Class IIVS II Aliquoter System calculator/data processing module, for clinical use Product...Roche Diagnostics GmbHJQP
Z-0102-2017Class IIcobas p 501 Post-Analytical Unit calculator/data processing module, for clinical...Roche Diagnostics GmbHJQP