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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 359 of 1190
FDA device recalls, page 359 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1434-2020Class IIBard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged...Bard Peripheral Vascular IncKNW
Z-1433-2020Class IIBard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged...Bard Peripheral Vascular IncKNW
Z-1432-2020Class IIBard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually...Bard Peripheral Vascular IncKNW
Z-1431-2020Class IIBard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged...Bard Peripheral Vascular IncKNW
Z-1356-2020Class IIZimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port...Zimmer Surgical SAKCY
Z-1268-2020Class IIPentax Video Colonoscope Model: EC38-i10LPENTAX of America, Inc.FDF
Z-1267-2020Class IIPentax Video Colonoscope Model: EC34-i10LPENTAX of America, Inc.FDF
Z-1169-2020Class IISPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral...Depuy Orthopaedics Inc.HTZ
Z-0918-2020Class IICustom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard...ROi CPS LLCLRO
Z-0989-2020Class IICoated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a...Ethicon, IncGAM
Z-1096-2020Class IIVaginal Verification Panel Ref 8208 Lot 8208-11Microbiologics, Inc.OHQ
Z-2002-2020Class IICentral Venous Catheters are indicated for the assessment of hemodynamic status through...Abbott MedicalDQE
Z-2001-2020Class IICentral Venous Catheters are indicated for the assessment of hemodynamic status through...Abbott MedicalDQE
Z-2000-2020Class IICentral Venous Catheters are indicated for the assessment of hemodynamic status through...Abbott MedicalDQE
Z-1999-2020Class IICentral Venous Catheters are indicated for the assessment of hemodynamic status through...Abbott MedicalDQE
Z-1998-2020Class IICentral Venous Catheters are indicated for the assessment of hemodynamic status through...Abbott MedicalDQE
Z-1997-2020Class IICentral Venous Catheters are indicated for the assessment of hemodynamic status through...Abbott MedicalDQE
Z-1996-2020Class IICentral Venous Catheters are indicated for the assessment of hemodynamic status through...Abbott MedicalDQE
Z-1001-2020Class IIMedonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product...Clinical Diagnostic Solutions, Inc.GKZ
Z-1350-2020Class IIUlrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for...ulrich medical USA IncKWP
Z-0820-2020Class IIKoios DS Breast . The device is a software application which assists skilled physicians...Koios Medical, Inc.LLZ
Z-1681-2020Class IIThermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF...Solta Medical, Inc.GEI
Z-1494-2020Class IICardio Vascular-Allura Centron, system code 722400Philips North America LLCOWB
Z-1493-2020Class IIAllura CV20, system code 722031Philips North America LLCOWB
Z-1492-2020Class IIUroDiagnost Eleva, system code 708033Philips North America LLCIXR
Z-1491-2020Class IIPoly G Integris H5000, System code 72246Philips North America LLCIZI
Z-1490-2020Class IIOmniDiagnost Eleva System codes 708028 708027Philips North America LLCOWB
Z-1489-2020Class IIMultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038Philips North America LLCIZI
Z-1488-2020Class IIIntegris Allura 9, system codes 722018 722021Philips North America LLCOWB
Z-1487-2020Class IIIntegris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)Philips North America LLCOWB
Z-1486-2020Class IIAllura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 7220...Philips North America LLCOWB
Z-1273-2020Class IITwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide...Smith & Nephew, Inc.MBI
Z-1102-2020Class IIWRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222Wright Medical Technology IncKWI
Z-1101-2020Class IIWRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220Wright Medical Technology IncKWI
Z-0815-2020Class IIDawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL...Cook IncorporatedGBO
Z-2105-2020Class IIKangaroo 924 Safety Screw Spike Set, Product Code 775759Medtronic, Inc.LZH
Z-2104-2020Class IIKangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659Medtronic, Inc.LZH
Z-2103-2020Class IIKangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code...Medtronic, Inc.LZH
Z-2102-2020Class IIKangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FDMedtronic, Inc.LZH
Z-2101-2020Class IIKangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559Medtronic, Inc.LZH
Z-2100-2020Class IIKangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code...Medtronic, Inc.LZH
Z-1125-2020Class IIPrometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable...Flowonix Medical IncLKK
Z-1124-2020Class IIPrometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion...Flowonix Medical IncLKK
Z-1123-2020Class IIUS Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable...Flowonix Medical IncLKK
Z-1122-2020Class IIPrometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump...Flowonix Medical IncLKK
Z-1121-2020Class IIPrometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump...Flowonix Medical IncLKK
Z-1120-2020Class IIPrometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion...Flowonix Medical IncLKK
Z-1727-2020Class IINikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and...Nikon MetrologyRCE
Z-1551-2020Class IIWave Prep Tubes (1710-03) and single use cups (17--00-24)Mavidon Medical ProdKOY
Z-0924-2020Class IINeodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device...JJGC Industria e Comercio de Materiais Dentarios SAEJL