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-0456-2010 | GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation... | GE Healthcare | LLZ | ||
| Z-0085-2010 | EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter... | Edwards Lifesciences LLC | DXC | ||
| Z-0084-2010 | EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS EndoClamp aortic... | Edwards Lifesciences LLC | DXC | ||
| Z-0140-2010 | Olsen Medical, MIDAS TOUCH NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011... | Olsen Medical | GEI | ||
| Z-0412-2010 | Power Supply -not sold separately, product code PWSP; Power Cord - Not sold separately... | Medtronic, Inc. | GDW | ||
| Z-0411-2010 | Device Sterilization Tray, product code T300. | Medtronic, Inc. | GDW | ||
| Z-0410-2010 | Rigid Curved Positioner, product code RCP; Rigid Curved Positioner O-Ring, product code... | Medtronic, Inc. | GDW | ||
| Z-0409-2010 | Intelligent Battery Pack, product code iB100; Intelligent Battery Charger and Power... | Medtronic, Inc. | GDW | ||
| Z-0408-2010 | Intelligent 60mm Articulating Endoscopic Linear Cutter, product code i60; Intelligent... | Medtronic, Inc. | GDW | ||
| Z-0407-2010 | Intelligent 60mm Straight Endoscopic Linear Cutter, product code i60S; Intelligent 60mm... | Medtronic, Inc. | GDW | ||
| Z-0406-2010 | Intelligent Delivery System, Straight, product code iDriveS; Intelligent Delivery System... | Medtronic, Inc. | GDW | ||
| Z-0405-2010 | Intelligent Reload, 45 mm Blue, product code iR45B; Intelligent Reload, 45 mm Green... | Medtronic, Inc. | GDW | ||
| Z-0404-2010 | Program Memory Card, product code MCV1A. | Medtronic, Inc. | GDW | ||
| Z-0403-2010 | Sterile Sheath, product code SS01. | Medtronic, Inc. | GDW | ||
| Z-0402-2010 | Power Console, product code PC100; Power Console System, product code PC100S; Power... | Medtronic, Inc. | GDW | ||
| Z-0401-2010 | Power Circular Stapler 21 mm Digital Loading Unit, product code PCS21; Power Circular... | Medtronic, Inc. | GDW | ||
| Z-0400-2010 | Endoscopic Linear Cutter Reload, 45 mm Blue, product code PLCR45B; Endoscopic Linear... | Medtronic, Inc. | GDW | ||
| Z-0399-2010 | Power Extender Straight, product code PES100; Power Extender Straight Reconditioned... | Medtronic, Inc. | GDW | ||
| Z-0398-2010 | Power Linear Cutter 75 mm, Reusable Digital Loading Unit, product code PLC75; Power... | Medtronic, Inc. | GDW | ||
| Z-0397-2010 | FlexShaft, product code FS14; FlexShaft II, product code FS214; FlexShaft III, product... | Medtronic, Inc. | GDW | ||
| Z-0396-2010 | Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code SLC55B; Straight... | Medtronic, Inc. | GDW | ||
| Z-0395-2010 | Remote Control Unit with Wire, product code RCW100. | Medtronic, Inc. | GDW | ||
| Z-0394-2010 | Right Angle Linear Cutter, 30 mm Digital Loading Unit, product code RALC30; Right Angle... | Medtronic, Inc. | GDW | ||
| Z-0393-2010 | Circular Stapler 21 mm Digital Loading Unit, product code CS21; Circular Stapler 25 mm... | Medtronic, Inc. | GDW | ||
| Z-0392-2010 | SurgASSIST System Storage Cart, product code CART; SurgASSIST Service Manual, product... | Medtronic, Inc. | GDW | ||
| Z-0509-2010 | IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number... | Numed Inc | LIT | ||
| Z-0189-2010 | Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number... | Siemens Medical Solutions USA, Inc. | JAA | ||
| Z-0106-2010 | Tri-State Hospital Supply Corp., Centurion Healthcare Products, Full Term Meconium Packs... | Centurion Medical Products, LP | BTR | ||
| Z-0105-2010 | Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile... | Centurion Medical Products, LP | BTR | ||
| Z-0493-2010 | ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-2140, DIAMETER 13mm, LENGTH 140mm, 1... | Wright Medical Technology Inc | MBH | ||
| Z-0492-2010 | ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-0140, DIAMETER 11mm, LENGTH 140mm, 1... | Wright Medical Technology Inc | MBH | ||
| Z-1156-2010 | CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number... | Boston Scientific Corporation | LPB | ||
| Z-0001-2010 | Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers... | Penumbra Inc. | DQY | ||
| Z-0525-2010 | Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile... | Zimmer GmbH | KWP | ||
| Z-0090-2010 | Vacuum Collection Bottle, 1 gallon (3200 mL); Ohio Medical Company, Gurnee, IL 60031... | Ohio Medical LLC | KDQ | ||
| Z-0089-2010 | Vacuum Collection Bottle, 1/2 gallon (1300 mL); Ohio Medical Company, Gurnee, IL 60031... | Ohio Medical LLC | KDQ | ||
| Z-0969-2010 | BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap... | Becton Dickinson & Co | MKZ | ||
| Z-1146-2010 | VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2... | Ventana Medical Systems Inc | MVC | ||
| Z-0175-2010 | Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast... | Boston Scientific Corporation | FFK | ||
| Z-0178-2010 | Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length... | Zimmer GmbH | HSD | ||
| Z-0177-2010 | Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length... | Zimmer GmbH | HSD | ||
| Z-2018-2012 | Class II | MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made... | Kimberly-Clark Corporation | FYA | |
| Z-2017-2012 | Class II | MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in... | Kimberly-Clark Corporation | FYA | |
| Z-2170-2010 | Hill-Rom Basic Care Bed, P1441A (Non-electric), Hill Rom Batesville, IN. Intended for... | Hill-Rom Inc. | FNJ | ||
| Z-2169-2010 | Hill-Rom Basic Care Bed, P1440A (Electric), Hill Rom Batesville, IN. Intended for low... | Hill-Rom Inc. | FNL | ||
| Z-2168-2010 | Hill-Rom 405 Bed, P1440B, (electric) Hill Rom Batesville, IN. Intended for low to... | Hill-Rom Inc. | FNL | ||
| Z-2167-2010 | Hill-Rom 305 Bed, P1441B - Non electric, Hill Rom Batesville, IN. Intended for low to... | Hill-Rom Inc. | FNJ | ||
| Z-1955-2010 | SSH-880CV Aplio Artida System | Canon Medical Systems USA, Inc. | IYO | ||
| Z-0579-2010 | Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR... | Invacare GmbH | ITI | ||
| Z-0490-2010 | LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP FOR POWER DRIVER, REF: 915-2185... | Biomet Microfixation | HWC |