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-2183-2010 | Stryker Atlas Transport Stretcher with Zoom, Model 660Z, Stryker Medical, Portage, MI | Stryker Medical | INK | ||
| Z-1634-2010 | Hudson RCI AQUA+ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range... | Teleflex Medical | BTT | ||
| Z-2397-2010 | Animas IR 1250 (1200 plus) Intended use:deliver insulin therapy | Animas Corp. | LZG | ||
| Z-2396-2010 | Animas IR 1200 Intended use:deliver insulin therapy | Animas Corp. | LZG | ||
| Z-2395-2010 | Animas 2020 Insulin Infusion Pumps Intended use:deliver insulin therapy | Animas Corp. | LZG | ||
| Z-2394-2010 | One Touch Ping Glucose Management Systems Intended use: deliver insulin therapy | Animas Corp. | LZG | ||
| Z-1525-2010 | PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex... | Bard Access Systems, Inc. | LJT | ||
| Z-1982-2011 | SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and... | Hsmg, Inc. D/b/a Smartinfuser USA | MEB | ||
| Z-1981-2011 | SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S. | Hsmg, Inc. D/b/a Smartinfuser USA | MEB | ||
| Z-2206-2010 | BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM... | Biomet Microfixation | DZL | ||
| Z-0456-2011 | i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott... | Abbott Medical | CGL | ||
| Z-1938-2010 | Dialysis Tray, SP560, Sterile, Micropore Surgical Tape, Single Use Rolls, Tri-State... | Centurion Medical Products, LP | FKG | ||
| Z-1937-2010 | C.A.P.D. Tubing Exchange Tray, HT80, Sterile, Micropore Surgical Tape, Single Use Rolls... | Centurion Medical Products, LP | FKG | ||
| Z-1936-2010 | Dialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape, Single Use Rolls, Port... | Centurion Medical Products, LP | FKG | ||
| Z-0348-2011 | VT-0101-50 Otological Ventilation Tubes, Catalog Number VT-0101-50, Donaldson, with tab... | Micromedics, Inc. | ETD | ||
| Z-0347-2011 | SP78100, SP78105 Nasal Products, Catalog Number SP-78100, Nasal Septal Button Standard... | Micromedics, Inc. | LFB | ||
| Z-0346-2011 | ATM100, LB-AP-M0001 Fibrijet, Catalog Number ATM100, Autoloous Thrombin Mixer (Blending... | Micromedics, Inc. | KYZ | ||
| Z-0345-2011 | AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678 Arteriocyte Medical systems, Magellan... | Micromedics, Inc. | KYZ | ||
| Z-2606-2010 | Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular... | Terumo Cardiovascular Systems Corporation | KFM | ||
| Z-0429-2011 | diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San... | Diadexus, Inc. | NOE | ||
| Z-2117-2010 | Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1559-2010 | VENTAK PRIZM Automatic Implantable Cardioverter Defibrillator (AICD). DR, model 1851, DR... | Boston Scientific Corporation | LWP | ||
| Z-1558-2010 | CONTAK RENEWAL 3 (Models H170), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Cardiac... | Boston Scientific Corporation | NIK | ||
| Z-1557-2010 | VITALITY Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies... | Boston Scientific Corporation | KRG | ||
| Z-1556-2010 | Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models... | Boston Scientific Corporation | LWP | ||
| Z-1555-2010 | Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD)... | Boston Scientific Corporation | LWP | ||
| Z-1554-2010 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models... | Boston Scientific Corporation | LWP | ||
| Z-1553-2010 | Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110... | Boston Scientific Corporation | LWP | ||
| Z-1653-2010 | Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate... | Blackstone Medical, Inc. | KWQ | ||
| Z-1442-2010 | Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101... | Medela AG | HGX | ||
| Z-2913-2011 | "***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER... | Biomet Microfixation | LXH | ||
| Z-1527-2010 | GE, 1009-9002-000 Avance Anesthesia Machine and Monitor | GE Healthcare | BSZ | ||
| Z-1526-2010 | GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor | GE Healthcare | BSZ | ||
| Z-1315-2010 | KODAK T-MAT G/RA Film, Catalog/REF # 151 0023, 24x30 cm, 5-100 Sheet Boxes FOLHAS/Hojas... | Eastman Kodak Company | IWZ | ||
| Z-1314-2010 | KODAK T-MAT L/RA Film, Catalog/REF # 181 4631, 35x43 cm 5-100 Sheet Boxes Folhas/Hojas... | Eastman Kodak Company | IWZ | ||
| Z-1446-2012 | Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually... | Alere San Diego, Inc. | DJR | ||
| Z-1995-2010 | Access Immunoassay Systems enhanced AccuTnl Reagent Kit; Part Number: A78803 The Access... | Siemens Healthcare Diagnostics Inc. | MMI | ||
| Z-1431-2010 | Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring | ConvaTec Limited | DRX | ||
| Z-0761-2017 | Class II | The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in... | Physio Control, Inc. | MKJ | |
| Z-0588-2011 | Dimension LIP Flex Reagent Cartridge, Catalog# DF55A | Siemens Healthcare Diagnostics Inc. | CHI | ||
| Z-1029-2011 | SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record... | Elekta Limited | IYE | ||
| Z-1434-2012 | Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG... | Abbott Medical | CIX | ||
| Z-1679-2010 | 19 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 20.5 mm minimum ream dia. x 260... | Zimmer GmbH | LPH | ||
| Z-1678-2010 | 19 mm Mallory Head Calcar 45 mm repl. femoral/100% porous 20.5 mm minimum ream dia. x 260... | Zimmer GmbH | LPH | ||
| Z-1677-2010 | 17 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 18.5 mm minimum ream dia. x 220... | Zimmer GmbH | LPH | ||
| Z-1676-2010 | 17 mm Mallory Head Calcar 45 mm repl. fmrl. /100% porous 18.5 mm minimum ream dia x 260... | Zimmer GmbH | LPH | ||
| Z-1675-2010 | Mallory Head Calcar Femoral 55 mm resection/porous coated 15.0 mm x 220 mm left stem... | Zimmer GmbH | LPH | ||
| Z-1674-2010 | Mallory Head Calcar Femoral, 55 mm resection/porous coated, 15.0 mm x 220 mm right... | Zimmer GmbH | LPH | ||
| Z-1673-2010 | Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm left stem... | Zimmer GmbH | LPH | ||
| Z-1672-2010 | Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm right... | Zimmer GmbH | LPH |