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-0611-2007 | Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000. | Maquet Cardiovascular LLC | MWS | ||
| Z-0395-2007 | Boston Scientific brand iLab Ultrasound Imaging System, for intravascular use; Model... | Boston Scientific Corporation | DQO | ||
| Z-0313-2007 | Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900. | Dentalez, Inc., Stardental Division | EFA | ||
| Z-0358-2007 | I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742 | Halyard Health | MEB | ||
| Z-0667-2007 | Disposable components of the superDimension Bronchus System: Locatable Guide Kit... | Medtronic, Inc. | JAK | ||
| Z-0666-2007 | superDimension Bronchus System (AAS00016-01), an image-guided localization system used to... | Medtronic, Inc. | JAK | ||
| Z-0148-2007 | AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses | Advanced Medical Optics, Inc. | HQL | ||
| Z-0476-2007 | Howmedica Hip Fracture Stem System No. 4 Femoral Component Fenestrated Sterile REF... | Howmedica Osteonics Corp | KWL | ||
| Z-0475-2007 | Howmedica Hip Fracture Stem System No. 3.5 Femoral Component Uses No. 3 Fenestrated... | Howmedica Osteonics Corp | KWL | ||
| Z-0474-2007 | Howmedica Hip Fracture Stem System No. 3 Femoral Component Fenestrated Sterile REF... | Howmedica Osteonics Corp | KWL | ||
| Z-0473-2007 | Howmedica Hip Fracture Stem System No. 2 Femoral Component Fenestrated Sterile REF... | Howmedica Osteonics Corp | KWL | ||
| Z-0472-2007 | Howmedica Hip Fracture Stem System, Product Number: 6942-0-10, No. 1 Femoral Component... | Howmedica Osteonics Corp | KWL | ||
| Z-0362-2008 | VKS Tibial Trial, Right/Left, Prep Guide; Model Number: 1214331, 1214332, 1214333... | Plus Orthopedics | JWH | ||
| Z-0338-2007 | Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with... | Edwards Lifesciences Technology SARL | DYG | ||
| Z-0635-2007 | Baxter Flo-Gard 6300 Dual Channel Volumetric Infusion Pump, catalog #2M8048, 2M8048R... | Baxter Healthcare Corporation | FRN | ||
| Z-0634-2007 | Baxter Flo-Gard 6200 Volumetric Infusion Pump, catalog #2M8043, 2M8043R (refurbished)... | Baxter Healthcare Corporation | FRN | ||
| Z-0633-2007 | Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R... | Baxter Healthcare Corporation | FRN | ||
| Z-0632-2007 | Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished)... | Baxter Healthcare Corporation | FRN | ||
| Z-0974-2007 | Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow... | Fisher & Paykel Healthcare, Inc. | BZD | ||
| Z-0973-2007 | Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451, 900HC451T, HC451A, HC452A &... | Fisher & Paykel Healthcare, Inc. | BZD | ||
| Z-0972-2007 | Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A & HC481SL. CPAP masks. | Fisher & Paykel Healthcare, Inc. | BZD | ||
| Z-0971-2007 | Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A... | Fisher & Paykel Healthcare, Inc. | BZD | ||
| Z-0970-2007 | Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A & 900HC401. CPAP masks. | Fisher & Paykel Healthcare, Inc. | BZD | ||
| Z-0969-2007 | Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: HC 431A, HC431SLL, HC431SLM &... | Fisher & Paykel Healthcare, Inc. | BZD | ||
| Z-0421-2007 | Desktop Pro R6.0 & R6.1, Linear Medical Accelerator. | Elekta Limited | IYE | ||
| Z-0289-2007 | KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo... | Kavo America | EFB | ||
| Z-0488-2007 | ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and... | Abbott Medical | CEP | ||
| Z-0268-2007 | Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical... | MEDLINE INDUSTRIES, LP - Northfield | LRO | ||
| Z-0505-2007 | LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral... | GE Healthcare Coils | LNH | ||
| Z-2065-2012 | Class I | OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage... | GE Healthcare | OXO | |
| Z-2040-2012 | Class I | OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic... | GE Healthcare | OXO | |
| Z-1865-2012 | Class II | OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film... | GE Healthcare | JAA | |
| Z-1818-2009 | T2 Ankle Arthrodesis Nail Surgical Protocol, Catalog Number LT2AA-OT, Stryker... | Howmedica Osteonics Corp | HSB | ||
| Z-1695-2008 | Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the... | Visx Incorporated, a Subsidiary of AMO Inc | LZS | ||
| Z-0376-2007 | Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program... | Bio-Rad Laboratories Inc. | JIT | ||
| Z-0541-2007 | Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of intravascular... | Biosense Webster Inc | DYB | ||
| Z-0540-2007 | Biosense Webster PREFACE Guiding Sheath, Anterior, for the introduction of intravascular... | Biosense Webster Inc | DYB | ||
| Z-0539-2007 | Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm, for the introduction of... | Biosense Webster Inc | DYB | ||
| Z-0538-2007 | Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of... | Biosense Webster Inc | DYB | ||
| Z-0537-2007 | Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of... | Biosense Webster Inc | DYB | ||
| Z-0469-2007 | Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136... | Mizuho USA, Inc. | LCX | ||
| Z-0303-2007 | Infinity Docking Station (IDS) (transportable patient monitor) Repair Kit, part number... | Draeger, Inc. | MHX | ||
| Z-0302-2007 | Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors... | Draeger, Inc. | MHX | ||
| Z-0301-2007 | Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers... | Draeger, Inc. | MHX | ||
| Z-0260-2007 | Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm... | Abbott Medical | JOH | ||
| Z-0232-2007 | XiVE S plus Screw Implant D3.0/L15, Model Number 26-0125, Friadent GmbH. (dental implant) | Dentsply Friadent Ceramed | DZE | ||
| Z-0231-2007 | XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123, Friadent GmbH. (dental implant) | Dentsply Friadent Ceramed | DZE | ||
| Z-0230-2007 | XiVE S plus Screw Implant D3.0/L11, Model Number 26-0122, Friadent GmbH. (dental implant) | Dentsply Friadent Ceramed | DZE | ||
| Z-0465-2007 | Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/left... | Depuy Orthopaedics Inc. | HRY | ||
| Z-0464-2007 | Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right... | Depuy Orthopaedics Inc. | HRY |