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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0956-2014 | Class I | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only... | Teleflex Medical | BTR | |
| Z-0955-2014 | Class I | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only... | Teleflex Medical | BTR | |
| Z-0954-2014 | Class I | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only... | Teleflex Medical | BTR | |
| Z-0953-2014 | Class I | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only... | Teleflex Medical | BTR | |
| Z-0952-2014 | Class I | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx... | Teleflex Medical | BTR | |
| Z-0951-2014 | Class I | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only... | Teleflex Medical | BTR | |
| Z-0950-2014 | Class I | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only... | Teleflex Medical | BTR | |
| Z-1076-2014 | Class II | Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro... | Siemens Healthcare Diagnostics Inc. | JIX | |
| Z-0847-2014 | Class II | Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11... | ZimVie US Corp LLC | DZE | |
| Z-0866-2014 | Class II | SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc... | Medtronic Sofamor Danek USA Inc | HXX | |
| Z-0820-2014 | Class II | Composix 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-0819-2014 | Class II | Composix 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-1306-2014 | Class II | i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring... | Abbott Medical | CHL | |
| Z-0903-2014 | Class II | Neptune 2 Rover Ultra Waste Management System | Stryker Corp. | JCX | |
| Z-0902-2014 | Class II | Neptune 2 Rover Ultra Waste Management System. | Stryker Corp. | JCX | |
| Z-0854-2014 | Class II | GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor... | GE Healthcare | MHX | |
| Z-0933-2014 | Class II | The Gaymar Medi-Therm device provides a means of regulating patient temperature by... | Stryker Medical | DWJ | |
| Z-0844-2014 | Class II | KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream... | Eastman Kodak Company | KPR | |
| Z-0812-2014 | Class II | Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an... | Vital Signs Colorado, Inc. | CAH | |
| Z-0707-2014 | Class II | 17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave ( Light Blue, Lavender Rings), 3... | Abbott Medical | FPA | |
| Z-0706-2014 | Class II | 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE Clear, Clamp, NanoClave... | Abbott Medical | FPA | |
| Z-0705-2014 | Class II | 6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv... | Abbott Medical | FPA | |
| Z-0704-2014 | Class II | 28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave T-Connector... | Abbott Medical | FPA | |
| Z-0703-2014 | Class II | 5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot... | Abbott Medical | FPA | |
| Z-0702-2014 | Class II | 5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot #... | Abbott Medical | FPA | |
| Z-0701-2014 | Class II | 5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot... | Abbott Medical | FPA | |
| Z-0700-2014 | Class II | 5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No... | Abbott Medical | FPA | |
| Z-0699-2014 | Class II | 120" 10 Drop Primary Set w/2 BCV-CLAVE, Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock... | Abbott Medical | FPA | |
| Z-0698-2014 | Class II | 30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock... | Abbott Medical | FPA | |
| Z-0697-2014 | Class II | 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock... | Abbott Medical | FPA | |
| Z-0696-2014 | Class II | 13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave Clear... | Abbott Medical | FPA | |
| Z-0695-2014 | Class II | 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer... | Abbott Medical | FPA | |
| Z-0694-2014 | Class II | 7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No... | Abbott Medical | FPA | |
| Z-0693-2014 | Class II | 10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave", Clamp... | Abbott Medical | FPA | |
| Z-0692-2014 | Class II | 10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave", Clamp... | Abbott Medical | FPA | |
| Z-0691-2014 | Class II | 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No... | Abbott Medical | FPA | |
| Z-0690-2014 | Class II | 6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock... | Abbott Medical | FPA | |
| Z-0689-2014 | Class II | 6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock... | Abbott Medical | FPA | |
| Z-0688-2014 | Class II | 7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No... | Abbott Medical | FPA | |
| Z-0687-2014 | Class II | 78" Ext Set w/2 BCV-Clave, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps... | Abbott Medical | FPA | |
| Z-0686-2014 | Class II | 106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon... | Abbott Medical | FPA | |
| Z-0685-2014 | Class II | 10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri- Connector, NanoClave"... | Abbott Medical | FPA | |
| Z-0684-2014 | Class II | 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave"... | Abbott Medical | FPA | |
| Z-0683-2014 | Class II | 7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave Clear, NThe ICU Needleless... | Abbott Medical | FPA | |
| Z-0682-2014 | Class II | 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave", Clamp... | Abbott Medical | FPA | |
| Z-0681-2014 | Class II | 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip... | Abbott Medical | FPA | |
| Z-0680-2014 | Class II | 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer... | Abbott Medical | FPA | |
| Z-0679-2014 | Class II | 8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No... | Abbott Medical | FPA | |
| Z-0678-2014 | Class II | 103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve... | Abbott Medical | FPA | |
| Z-0677-2014 | Class II | 14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, 2 Clamps... | Abbott Medical | FPA |
