510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
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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

59,528 records, page 720 of 1191
FDA device recalls, page 720 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0956-2014Class IISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only...Teleflex MedicalBTR
Z-0955-2014Class IISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only...Teleflex MedicalBTR
Z-0954-2014Class IISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only...Teleflex MedicalBTR
Z-0953-2014Class IISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only...Teleflex MedicalBTR
Z-0952-2014Class IISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx...Teleflex MedicalBTR
Z-0951-2014Class IISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only...Teleflex MedicalBTR
Z-0950-2014Class IISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only...Teleflex MedicalBTR
Z-1076-2014Class IIDimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro...Siemens Healthcare Diagnostics Inc.JIX
Z-0847-2014Class IITapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11...ZimVie US Corp LLCDZE
Z-0866-2014Class IISET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc...Medtronic Sofamor Danek USA IncHXX
Z-0820-2014Class IIComposix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo...Davol Inc., Sub. C.R. Bard, Inc.FTL
Z-0819-2014Class IIComposix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo...Davol Inc., Sub. C.R. Bard, Inc.FTL
Z-1306-2014Class IIi-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring...Abbott MedicalCHL
Z-0903-2014Class IINeptune 2 Rover Ultra Waste Management SystemStryker Corp.JCX
Z-0902-2014Class IINeptune 2 Rover Ultra Waste Management System.Stryker Corp.JCX
Z-0854-2014Class IIGE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor...GE HealthcareMHX
Z-0933-2014Class IIThe Gaymar Medi-Therm device provides a means of regulating patient temperature by...Stryker MedicalDWJ
Z-0844-2014Class IIKODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream...Eastman Kodak CompanyKPR
Z-0812-2014Class IIVital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an...Vital Signs Colorado, Inc.CAH
Z-0707-2014Class II17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave ( Light Blue, Lavender Rings), 3...Abbott MedicalFPA
Z-0706-2014Class II6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE Clear, Clamp, NanoClave...Abbott MedicalFPA
Z-0705-2014Class II6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv...Abbott MedicalFPA
Z-0704-2014Class II28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave T-Connector...Abbott MedicalFPA
Z-0703-2014Class II5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot...Abbott MedicalFPA
Z-0702-2014Class II5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot #...Abbott MedicalFPA
Z-0701-2014Class II5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot...Abbott MedicalFPA
Z-0700-2014Class II5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No...Abbott MedicalFPA
Z-0699-2014Class II120" 10 Drop Primary Set w/2 BCV-CLAVE, Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock...Abbott MedicalFPA
Z-0698-2014Class II30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock...Abbott MedicalFPA
Z-0697-2014Class II8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock...Abbott MedicalFPA
Z-0696-2014Class II13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave Clear...Abbott MedicalFPA
Z-0695-2014Class II11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer...Abbott MedicalFPA
Z-0694-2014Class II7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No...Abbott MedicalFPA
Z-0693-2014Class II10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave", Clamp...Abbott MedicalFPA
Z-0692-2014Class II10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave", Clamp...Abbott MedicalFPA
Z-0691-2014Class II7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No...Abbott MedicalFPA
Z-0690-2014Class II6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock...Abbott MedicalFPA
Z-0689-2014Class II6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock...Abbott MedicalFPA
Z-0688-2014Class II7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No...Abbott MedicalFPA
Z-0687-2014Class II78" Ext Set w/2 BCV-Clave, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps...Abbott MedicalFPA
Z-0686-2014Class II106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon...Abbott MedicalFPA
Z-0685-2014Class II10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri- Connector, NanoClave"...Abbott MedicalFPA
Z-0684-2014Class II7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave"...Abbott MedicalFPA
Z-0683-2014Class II7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave Clear, NThe ICU Needleless...Abbott MedicalFPA
Z-0682-2014Class II7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave", Clamp...Abbott MedicalFPA
Z-0681-2014Class II6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip...Abbott MedicalFPA
Z-0680-2014Class II6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer...Abbott MedicalFPA
Z-0679-2014Class II8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No...Abbott MedicalFPA
Z-0678-2014Class II103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve...Abbott MedicalFPA
Z-0677-2014Class II14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, 2 Clamps...Abbott MedicalFPA