510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 366 of 1190
FDA device recalls, page 366 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0715-2020Class IIArrow Berman Angiographic Catheter 50cc Item Number: AI-07130Arrow International LLC (subsidiary of Teleflex Incorporated)DYG
Z-1409-2020Class IIRevaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745LBaxter Healthcare CorporationKDI
Z-0745-2020Class IIIAIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of...Tosoh Bioscience IncCDD
Z-0930-2020Class IPneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the...Tytek Medical IncBWC
Z-2298-2020Class IIHardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium...Hardy DiagnosticsJSO
Z-1558-2020Class IIFreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810Abbott MedicalJIN
Z-1557-2020Class IIOptium EZ Blood Glucose Monitoring System, UDI: 00093815710653Abbott MedicalNBW
Z-1556-2020Class IIPrecision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023...Abbott MedicalNBW
Z-0693-2020Class IIMedtronic Affinity, 38um Arterial Filter, Catalog number REF 351Medtronic Perfusion SystemsDTM
Z-0695-2020Class IIArtis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142...Siemens Medical Solutions USA, Inc.OWB
Z-0730-2020Class IICordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL...Medtronic, Inc.NIP
Z-0729-2020Class IICordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices...Medtronic, Inc.NIM
Z-0728-2020Class IIS.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The...Medtronic, Inc.NIO
Z-0767-2021Class IIEleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45...LINET spol. s r.o.FNL
Z-0735-2020Class IILamicel 10PK 10MM INTLMedtronic Xomed, Inc.LOB
Z-0734-2020Class IILamicel 20PK 5MM INTLMedtronic Xomed, Inc.LOB
Z-0733-2020Class IILamicel 20PK 3MM INTL Cervical dilatorMedtronic Xomed, Inc.LOB
Z-0677-2020Class IIMaquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator...Getinge US Sales LLCDTZ
Z-1391-2022Class IIENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee...Aesculap IncLXH
Z-0727-2020Class IICARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with...GE HealthcareDSI
Z-0726-2020Class IICIC Pro Clinical Information Center Central Station - Product Usage: The intended use is...GE HealthcareDSI
Z-0725-2020Class IIApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for...GE HealthcareDSI
Z-1234-2020Class IIMedicrea International Universal Counter Torque for use with the Pass TULIP [Spinal]...Medicrea InternationalNKB
Z-0778-2020Class IIStratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550STMedartis AGHWC
Z-0777-2020Class IIStratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548STMedartis AGHWC
Z-0776-2020Class IIStratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546STMedartis AGHWC
Z-0696-2020Class IIsmith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is...Smith & Nephew, Inc.GFJ
Z-0720-2020Class IICLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S...Abbott MedicalGXI
Z-0717-2020Class IIAngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 1056...Boston Scientific CorporationMCX
Z-0590-2020Class ICrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For...Cook IncorporatedKRA
Z-0589-2020Class ICrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For...Cook IncorporatedKRA
Z-0588-2020Class ICrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For...Cook IncorporatedKRA
Z-0587-2020Class ICrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For...Cook IncorporatedKRA
Z-0811-2020Class IIStryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or...Howmedica Osteonics CorpJDI
Z-0675-2020Class IICognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep...Neuronetrix Solutions, LLCKOY
Z-0656-2020Class IILigamax 5 mm Endoscopic Multiple Clip ApplierEthicon Endo-Surgery IncFZP
Z-0843-2020Class IIiChem VELOCITY Urine Chemistry AnalyzerSiemens Healthcare Diagnostics Inc.KQO
Z-0574-2020Class IIARCHITECT HAVAB-G Calibrator, REF 6L27-01Abbott MedicalLOL
Z-1672-2020Class IIThe FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement...Qualigen IncCDZ
Z-1500-2020Class IIRheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code...The Binding Site Group Ltd.DHR
Z-0702-2020Class IIINATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X...AllerganMRD
Z-0701-2020Class IIINatrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes...AllerganFTR
Z-0700-2020Class IIINatrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10...AllerganFTR
Z-0699-2020Class IIINatrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP...AllerganFWM
Z-0593-2020Class IIColor Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual...Stryker Corp.KCY
Z-0592-2020Class IIColor Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder)...Stryker Corp.KCY
Z-2074-2020Class IIDako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link...Agilent Technologies Denmark ApSKPA
Z-0916-2020Class IKing Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a...King Systems Corporation.CCW
Z-0912-2020Class IIGIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product...Collagen Matrix, IncNPL
Z-0911-2020Class IIGIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product...Collagen Matrix, IncNPL