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-1011-2010 | BD BACTEC(TM) Plus Anaerobic/F Medium, catalog 442193, packed in tubes, 50 tubes/case and... | Becton Dickinson & Co | MDB | ||
| Z-1010-2010 | BD BACTEC(TM) Standard 10 Aerobic/F Medium, catalog 442260, packed in tubes, 50... | Becton Dickinson & Co | MDB | ||
| Z-1009-2010 | BD BACTEC(TM) Lytic 10 Anaerobic/F Medium, catalog 442265, packed in tubes, 50 tubes/case... | Becton Dickinson & Co | MDB | ||
| Z-1008-2010 | BD BACTEC(TM) Plus + Aerobic/F Medium, catalog 442192, packed in tubes, 50 tubes/case and... | Becton Dickinson & Co | MDB | ||
| Z-0529-2010 | Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; Stainless Steel... | Howmedica Osteonics Corp | HTS | ||
| Z-0605-2010 | AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00) | Advanced Medical Optics, Inc. | HQL | ||
| Z-1625-2011 | Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit... | Medtronic, Inc. | JDZ | ||
| Z-1624-2011 | Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity... | Medtronic, Inc. | NDN | ||
| Z-0560-2010 | Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - SS with Ziploop... | Zimmer GmbH | MBI | ||
| Z-0559-2010 | Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - Titanium with... | Zimmer GmbH | MBI | ||
| Z-0860-2010 | Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog #... | Horiba Instruments Incorporated | LBR | ||
| Z-0859-2010 | Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set... | Horiba Instruments Incorporated | LBR | ||
| Z-1043-2010 | Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set... | Horiba Instruments Incorporated | CIC | ||
| Z-1042-2010 | Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set... | Horiba Instruments Incorporated | CIC | ||
| Z-1041-2010 | Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe... | Horiba Instruments Incorporated | CIC | ||
| Z-1277-2013 | Class II | Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for... | OLYMPUS Corporation of the Americas | KNS | |
| Z-0582-2010 | Delta/Delta XL Monitors with Omega S Package | Draeger, Inc. | MHX | ||
| Z-1068-2010 | CHROMagar 0157; 5000 ml (29.2 g/L) EE222; IVD For In Vitro Diagnostic Use, CHROMagar... | DRG International, Inc. | JSO | ||
| Z-1067-2010 | CHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a... | DRG International, Inc. | JSO | ||
| Z-1232-2010 | Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy... | Elekta Limited | IWB | ||
| Z-1834-2011 | Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation... | Siemens Medical Solutions USA, Inc. | MUJ | ||
| Z-0538-2010 | Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF... | Biomet Microfixation | HBE | ||
| Z-1075-2010 | Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD... | Medical Action Industries, Inc. 306 | FPA | ||
| Z-1074-2010 | Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum... | Medical Action Industries, Inc. 306 | FPA | ||
| Z-1073-2010 | Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD... | Medical Action Industries, Inc. 306 | FPA | ||
| Z-0497-2010 | TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920... | Medtronic, Inc. | DQY | ||
| Z-0478-2010 | Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x... | Medtronic, Inc. | FGE | ||
| Z-0499-2010 | Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc... | Zimmer GmbH | DZE | ||
| Z-0649-2010 | Spacelabs Model 91370 SL 2600 Compact Monitor Spacelabs Medical patient monitors... | GE Healthcare | DXJ | ||
| Z-0648-2010 | Spacelabs Model 91369-24 SL 2400 Compact Monitor Spacelabs Medical patient monitors... | GE Healthcare | DXJ | ||
| Z-0647-2010 | Spacelabs Model 91367 SL 2200 Compact Monitor Spacelabs Medical patient monitors... | GE Healthcare | DXJ | ||
| Z-1133-2010 | Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical... | Abbott Medical | CGA | ||
| Z-2240-2012 | Class II | 892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide... | GE Healthcare | JAA | |
| Z-0667-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA... | KCI USA, Inc. | OMP | ||
| Z-0666-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA... | KCI USA, Inc. | OMP | ||
| Z-0665-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA... | KCI USA, Inc. | OMP | ||
| Z-0664-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA... | KCI USA, Inc. | IKY | ||
| Z-0663-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA... | KCI USA, Inc. | IOQ | ||
| Z-0662-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA... | KCI USA, Inc. | IOQ | ||
| Z-0923-2010 | Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO... | Medtronic Navigation, Inc | HAW | ||
| Z-0566-2010 | Stille Sonesta Gynecology and Urology Table 6303 ; an electric cystometric table; Stille... | Stille AB | MMZ | ||
| Z-0565-2010 | Stille Sonesta Gynecology and Urology Table 6302 and 6302U; an electric cystometric... | Stille AB | MMZ | ||
| Z-0564-2010 | Stille Sonesta Urodynamic Table 6202 Gynecology/Urology Procedure Chair; an electric... | Stille AB | MMZ | ||
| Z-0487-2010 | Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL... | Baxter Healthcare Corporation | FPA | ||
| Z-1196-2010 | Heartstart HS1 Defibrillator Model M5068A | Philips North America LLC | NSA | ||
| Z-1195-2010 | Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A | Philips North America LLC | MKJ | ||
| Z-1194-2010 | Philips Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog number... | Philips North America LLC | MKJ | ||
| Z-1193-2010 | Philips Heartstart FRx automated external defibrillator (AED), Model 861304 | Philips North America LLC | MKJ | ||
| Z-0481-2010 | Animas ezManager Max Diabetes Management System version 2.0.9 | Animas Corp. | MRZ | ||
| Z-0558-2010 | Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF... | Zimmer GmbH | HAW |