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-2584-2011 | Philips SureSigns VS3 Vital Signs Monitor Models: VS3 863069, 863070, 453564041251... | Philips North America LLC | DPS | ||
| Z-2583-2011 | Philips SureSigns VM Series Patient Monitors: VM4, VM6, VM 8: Model Part... | Philips North America LLC | MHX | ||
| Z-2770-2011 | Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x... | Vascular Solutions LLC | DQO | ||
| Z-2919-2011 | XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and... | Elekta Limited | MUJ | ||
| Z-1620-2012 | Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay... | Diamedix Corp. | LLL | ||
| Z-0297-2012 | Multigent Vancomycin Calibrators; Manufactured by Microgenics Corp, Fremont... | Microgenics Corporation | DLJ | ||
| Z-2902-2011 | Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs... | GE Healthcare | CBR | ||
| Z-2754-2011 | Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number... | Medtronic, Inc. | DQY | ||
| Z-2612-2011 | 45cm Laparoscopic Instruments Sterilization tray. Manufactured by: Stryker Endoscopy... | Stryker Corp. | KCT | ||
| Z-1188-2012 | Aerolase Corporation. The products involved are the FriendlyLight YAG lasers, a Model... | Aerolase Corporation | GEX | ||
| Z-0152-2012 | ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen... | Ameditech, Inc. | DKZ | ||
| Z-0042-2012 | IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience... | Meridian Bioscience Israel Ltd. | MSQ | ||
| Z-3259-2011 | ANGIODYNAMICS Angiographic Catheter, Soft-Vu Cobra (2) BRAIDED, 5 F x 90 cm x .035 in... | Angiodynamics Worldwide Headquarters | DQO | ||
| Z-0008-2012 | OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed... | Osteomed | MRW | ||
| Z-2691-2011 | Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product... | Wilson-Cook Medical Inc. | MND | ||
| Z-0212-2012 | IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX... | AGFA Healthcare Corp. | LLZ | ||
| Z-0272-2012 | IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular... | AGFA Healthcare Corp. | LLZ | ||
| Z-0211-2012 | IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8... | AGFA Healthcare Corp. | LLZ | ||
| Z-3052-2011 | High-Definition 120 Multileaf Collimator HD 120 MLC is an accessory x-ray collimator... | Varian Medical Systems, Inc. | IYE | ||
| Z-2836-2011 | Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape. | Kimberly-Clark Corporation | KKX | ||
| Z-2885-2011 | The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that... | Physio Control, Inc. | MKJ | ||
| Z-2790-2011 | HUDSON RCI, Humidifier Adaptor, Rx only, Teleflex Medical, Research Triangle Park, NC... | Teleflex Medical | BTT | ||
| Z-0194-2012 | Stryker Restoration ADM System Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ... | Howmedica Osteonics Corp | LZO | ||
| Z-0193-2012 | Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325... | Howmedica Osteonics Corp | LZO | ||
| Z-0192-2012 | Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; Howmedica Osteonics... | Howmedica Osteonics Corp | LZO | ||
| Z-2914-2011 | Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed... | Philips North America LLC | KPS | ||
| Z-3003-2011 | ARTISTE Linear Accelerator with RT Therapist v4.1 system. Siemens Medical Solutions... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2977-2011 | ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems. Manufactured by Siemens AG... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2830-2011 | Syneture Ti-Cron 0 5X18" BLUE T-40/HGS-22 D-TACH, non-absorbable polyester... | Medtronic, Inc. | GAP | ||
| Z-2829-2011 | Syneture Ti-Cron 2 BLUE 5X18" HGS-22 non-absorbable polyester sutures Material... | Medtronic, Inc. | GAP | ||
| Z-2828-2011 | Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach non-absorbable polyester sutures Material... | Medtronic, Inc. | GAP | ||
| Z-2827-2011 | Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach non-absorbable polyester sutures Material... | Medtronic, Inc. | GAP | ||
| Z-2826-2011 | Syneture Ti-Cron 0 5X18" BLUE T-19/GS-22 D-TACH non-absorbable polyester... | Medtronic, Inc. | GAP | ||
| Z-2825-2011 | Syneture Ti-Cron 0 BLUE 6X18" PRE-CUT non-absorbable polyester sutures Material... | Medtronic, Inc. | GAP | ||
| Z-2824-2011 | Syneture Surgilon 4/0 BLK 5X18 CV-22 D*TACH JLDT non-absorbable braided nylon... | Medtronic, Inc. | GAP | ||
| Z-2823-2011 | Syneture Surgilon 0 Black 5X18 T-3/GS-23 D-TACH non-absorbable braided nylon... | Medtronic, Inc. | GAP | ||
| Z-2822-2011 | Syneture Surgilon 0 Blk 5X18 T-12/GS-21 D-TACH non-absorbable braided nylon... | Medtronic, Inc. | GAP | ||
| Z-2821-2011 | Syneture Surgilon 0 Blk 3X18 CE-10/C-16 non-absorbable braided nylon sutures Material... | Medtronic, Inc. | GAP | ||
| Z-2820-2011 | Syneture Surgilon 5/0 Blk 5X18 T-37/CV-20 D-TACH non-absorbable braided nylon sutures... | Medtronic, Inc. | GAP | ||
| Z-2819-2011 | Syneture Sofsilk 0 BLACK 6X 18" PRE-CUT WAX/RACE non-absorbable braided nylon... | Medtronic, Inc. | GAP | ||
| Z-2818-2011 | Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE non-absorbable braided nylon... | Medtronic, Inc. | GAP | ||
| Z-2817-2011 | Syneture Sofsilk 2/0 30" BLACK V-20 DT non-absorbable braided nylon... | Medtronic, Inc. | GAP | ||
| Z-2816-2011 | Syneture Sofsilk 3/0 18" BLACK V-20 DT non-absorbable braided nylon... | Medtronic, Inc. | GAP | ||
| Z-2815-2011 | Syneture Sofsilk 2/0 BLACK 5x18" V-20 D-TACH non-absorbable silk sutures GS62M Sofsilk... | Medtronic, Inc. | GAP | ||
| Z-2814-2011 | Syneture Sofsilk 4/0 18" BLACK CV-22 DT non-absorbable silk sutures GS46M Sofsilk is... | Medtronic, Inc. | GAP | ||
| Z-2813-2011 | Syneture Sofsilk 4/0 18" BLACK CV-22 DT non-absorbable silk sutures GS44M Sofsilk is... | Medtronic, Inc. | GAP | ||
| Z-2812-2011 | Syneture Sofsilk 5/0 BLACK 5 X 18" CV-22 D*TACH non-absorbable silk sutures... | Medtronic, Inc. | GAP | ||
| Z-2811-2011 | Syneture Sofsilk 3/0 18" BLACK CV-25 DT non-absorbable silk sutures GS33M Sofsilk is... | Medtronic, Inc. | GAP | ||
| Z-2810-2011 | Syneture Sofsilk 0 18" BLACK GS-21 DT non-absorbable braided nylon... | Medtronic, Inc. | GAP | ||
| Z-2872-2011 | Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number... | Philips North America LLC | KPS |