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-1665-2011 | TSX-301A: AQUILION ONE System AQUILION ONE is a multislice CT system that supports whole... | Canon Medical Systems USA, Inc. | JAK | ||
| Z-2176-2010 | Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton, NJ... | Ikaria Holdings | MRN | ||
| Z-2266-2010 | Philips M1026BT Gas Modules with manifolds | Philips North America LLC | BSZ | ||
| Z-2265-2010 | Philips M1026B IntelliVue Anesthesia Gas Modules with manifolds | Philips North America LLC | BSZ | ||
| Z-2264-2010 | Philips M1019A IntelliVue G5 Anesthesia Gas Modules with manifolds | Philips North America LLC | BSZ | ||
| Z-2263-2010 | Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds | Philips North America LLC | BSZ | ||
| Z-1044-2011 | Ge Senographe Ds Full Field Mammography System Mammographic Film / Screen System | GE Healthcare | MUE | ||
| Z-1043-2011 | GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The expected... | GE Healthcare | MUE | ||
| Z-0821-2011 | Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29... | Varian Medical Systems, Inc. | IYE | ||
| Z-1004-2011 | Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging... | Optovue Inc. | NQQ | ||
| Z-2314-2010 | PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 HOLE, RIGHT - 148 MM, REF... | Smith & Nephew, Inc. | HRS | ||
| Z-2242-2010 | CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene... | CIVCO Medical Instruments Co., Inc. | ITX | ||
| Z-2313-2010 | VP 2000 Processor Heated Reagent Basins; automated slide stainer; Abbott Molecular Inc... | Abbott Molecular, Inc. | KPA | ||
| Z-0007-2012 | Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and... | B Braun Medical Inc | FRN | ||
| Z-0088-2011 | SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version... | SCC Soft Computer | LNX | ||
| Z-2201-2011 | Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version... | Bio-Rad Laboratories Inc. | LFX | ||
| Z-2399-2010 | Peregrine 20 GA Endo Ocular Adjustable Laser Probe | Peregrine Surgical, LLC. | HQF | ||
| Z-2445-2010 | Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with... | Johnson & Johnson Vision Care, Inc. | LPM | ||
| Z-0095-2011 | Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties... | Cerenovus, Inc. | HBA | ||
| Z-0094-2011 | Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code... | Cerenovus, Inc. | HBA | ||
| Z-0093-2011 | Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code... | Cerenovus, Inc. | HBA | ||
| Z-2273-2010 | Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate... | Medtronic, Inc. | MAV | ||
| Z-2272-2010 | Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate... | Medtronic, Inc. | MAV | ||
| Z-2271-2010 | Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate... | Medtronic, Inc. | MAV | ||
| Z-0322-2011 | HeartStart MRx Defibrillator/Monitor Models: M3535A / M3536A / M3536J / M3536MC The... | Philips North America LLC | MKJ | ||
| Z-2275-2010 | CARESCAPE MONITOR B850 Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high... | GE Healthcare | MHX | ||
| z-2640-2010 | Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo... | Stryker Corp. | LFL | ||
| Z-2380-2010 | Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care... | Vital Signs, Inc. | LGZ | ||
| Z-1675-2011 | Toshiba DUA-450F Kalare Radiographic Tilting Table. | Canon Medical Systems USA, Inc. | IXR | ||
| Z-2331-2010 | Boston Scientific Ultraflex Precision Colonic Stent System Material/UPN/Catalog Number... | Boston Scientific Corporation | MQR | ||
| Z-2330-2010 | Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release... | Boston Scientific Corporation | JCT | ||
| Z-2329-2010 | Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release... | Boston Scientific Corporation | JCT | ||
| Z-2328-2010 | Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release... | Boston Scientific Corporation | JCT | ||
| Z-2327-2010 | Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release... | Boston Scientific Corporation | JCT | ||
| Z-2326-2010 | Boston Scientific Ultraflex Covered Tracheobronchial Stent System -- Distal Release... | Boston Scientific Corporation | JCT | ||
| Z-2325-2010 | Boston Scientific Ultraflex Uncovered Tracheobronchial Stent System - Proximal Release... | Boston Scientific Corporation | JCT | ||
| Z-2324-2010 | Boston Scientific Ultraflex Covered Large Esophageal Stent System - Proximal Release... | Boston Scientific Corporation | ESW | ||
| Z-2323-2010 | Boston Scientific Ultraflex Uncovered Large Esophageal Stent System - Distal Release... | Boston Scientific Corporation | ESW | ||
| Z-2322-2010 | Boston Scientific Ultraflex Covered large Esophageal Stent System - Distal Release... | Boston Scientific Corporation | ESW | ||
| Z-2321-2010 | Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release... | Boston Scientific Corporation | ESW | ||
| Z-2320-2010 | Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release... | Boston Scientific Corporation | ESW | ||
| Z-2319-2010 | Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release... | Boston Scientific Corporation | ESW | ||
| Z-2318-2010 | Boston Scientific Ultraflex Uncovered Esophageal Stent System - Proximal Release... | Boston Scientific Corporation | ESW | ||
| Z-2317-2010 | Boston Scientific Ultraflex Covered Esophageal Stent System - Distal Release Distal... | Boston Scientific Corporation | ESW | ||
| Z-2316-2010 | Boston Scientific Ultraflex Uncovered Esophageal Stent System - Distal Release... | Boston Scientific Corporation | ESW | ||
| Z-2243-2010 | Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an... | BioCheck Inc | NUK | ||
| Z-0834-2011 | GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser... | American Medical Systems Innovation Center - Silicon Valley | GEX | ||
| Z-0745-2012 | Baxter Colleague 3 Triple Channel Volumetric Infusion Pump. Baxter Healthcare... | Baxter Healthcare Corporation | FRN | ||
| Z-0744-2012 | Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter... | Baxter Healthcare Corporation | FRN | ||
| Z-1374-2011 | AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number... | Advanced Medical Optics, Inc. | LZS |