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-2871-2011 | Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number... | Philips North America LLC | KPS | ||
| Z-2870-2011 | Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number... | Philips North America LLC | KPS | ||
| Z-2869-2011 | Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number... | Philips North America LLC | KPS | ||
| Z-2868-2011 | Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number... | Philips North America LLC | KPS | ||
| Z-2867-2011 | Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number... | Philips North America LLC | -KPS | ||
| Z-2858-2011 | Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage The... | Terumo Medical Corp. | DQX | ||
| Z-2781-2011 | DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system... | Medtronic Navigation, Inc | HAW | ||
| Z-2886-2011 | ***** EXPANDED RECALL ***** Rusch Foley Catheter Insertion Tray with Preconnected Bag... | Teleflex Medical | FAQ | ||
| Z-3281-2011 | Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. The... | Philips North America LLC | JAK | ||
| Z-2866-2011 | MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500... | Medrad, Inc. | DXT | ||
| Z-2768-2011 | VITEK 2 System, VITEK 2 XL 110V (Catalog #27227) and VITEK 2 XL 220V (Catalog... | bioMerieux, Inc. | LTW | ||
| Z-2767-2011 | VITEK 2 System, VITEK 2 60 110V (Catalog #27225) and VITEK 2 60 220V (Catalog... | bioMerieux, Inc. | LTW | ||
| Z-2672-2011 | RUSCH Urinary Drainage Bag, 2000 ml Product Usage: For one time use per the Directions... | Teleflex Medical | FAQ | ||
| Z-2955-2011 | Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters... | Abbott Medical | IKD | ||
| Z-2888-2011 | WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to... | Gentherm Medical, LLC | DWJ | ||
| Z-2769-2011 | The SIU (System Interface Unit) is a component in the Tool Connection Unit of the... | Philips North America LLC | JAK | ||
| Z-1744-2014 | Class II | BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes... | Bioderm, Inc. | NEC | |
| Z-1743-2014 | Class II | BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral... | Bioderm, Inc. | NEC | |
| Z-1742-2014 | Class II | BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection... | Bioderm, Inc. | NEC | |
| Z-1325-2013 | Class II | Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model... | Varian Medical Systems, Inc. | IYE | |
| Z-2806-2011 | GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili : 75 test... | Instrumentation Laboratory Co. | CEM | ||
| Z-2805-2011 | GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox/tBili 75 test iQM... | Instrumentation Laboratory Co. | CEM | ||
| Z-2804-2011 | GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox 75 test iQM... | Instrumentation Laboratory Co. | CEM | ||
| Z-3201-2011 | Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems, Model Number: 882476, 510(k)... | Philips North America LLC | KPS | ||
| Z-3200-2011 | Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640... | Philips North America LLC | JAK | ||
| Z-3199-2011 | Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640... | Philips North America LLC | JAK | ||
| Z-3012-2011 | GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration, GE... | GE Healthcare | LLZ | ||
| Z-2887-2011 | IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot... | Siemens Healthcare Diagnostics Inc. | DHR | ||
| Z-2803-2011 | GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox 75 test iQM... | Instrumentation Laboratory Co. | CEM | ||
| Z-2708-2011 | Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile... | Baxter Healthcare Corporation | FPA | ||
| Z-2694-2011 | Tobii C-Series Lithium batteries Type TB8A, TB8B, TB12A used with the Tobii C8 and Tobii... | Tobii Assistive Technology, Inc. | ILQ | ||
| Z-2378-2012 | Class II | The product affected by this notice is sold under the trade name TomoTherapy SharePlan... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-0824-2012 | HemoCue Glucose 201 Microcuvettes, Article Number:110705*,110706,110715**,110716**,11071... | Hemo Cue, Inc. | CGA | ||
| Z-3080-2011 | Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23... | ZOLL Medical Corporation | cbk | ||
| Z-2834-2011 | LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000... | DCI International, LLC | EAZ | ||
| Z-2835-2011 | OneTouch Delica Lancing Device; LifeScan Inc., Milpitas, CA Testing of Blood Glucose... | Lifescan, Inc. | F | ||
| Z-2901-2011 | AxioBionics Wearable Therapy BioVest/Unitard that includes 2-16 BioGel Velcro Electrodes... | Axiobionics, LLC, Center for Neuroprosthetics | GXY | ||
| Z-2900-2011 | AxioBionics Wearable Therapy BioShorts that includes 2-16 BioGel Velcro Electrodes in... | Axiobionics, LLC, Center for Neuroprosthetics | GXY | ||
| Z-2899-2011 | AxioBionics Wearable TherapyFreeStep Sleeve (Right and Left) that includes 2-16 BioGel... | Axiobionics, LLC, Center for Neuroprosthetics | GXY | ||
| Z-2898-2011 | AxioBionics Wearable Therapy Upper Extremity BioSleeve (Right and Left) that includes... | Axiobionics, LLC, Center for Neuroprosthetics | GXY | ||
| Z-2746-2011 | Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, STERILE, QTY 1... | Stryker Corp. | MDM | ||
| Z-0312-2012 | Elekta Leksell Gamma Knife C 1.2, 4 and 4C Product Usage: Leksell Gamma Knife is a... | Elekta Limited | IWB | ||
| Z-2856-2011 | PALL Medical LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop... | Pall Corporation | LGB | ||
| Z-2978-2011 | Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators. Varian Medical Systems... | Varian Medical Systems, Inc. | IYE | ||
| Z-1036-2012 | Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478... | Viterion Telehealthcare, LLC | MWI | ||
| Z-0014-2012 | Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy. | Elekta Limited | MUJ | ||
| Z-3030-2011 | Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Mfr. By: Tosoh... | Tosoh Bioscience Inc | JPD | ||
| Z-3183-2011 | LATITUDE Patient Management System Communicator, Model 6482. The LATITUDE Patient... | Boston Scientific Corporation | LWS | ||
| Z-2833-2011 | Boston Scientific, WALLGRAFT OVER-THE-WIRE, Tracheobronchial Endoprosthesis, Made in... | Boston Scientific Corporation | JCT | ||
| Z-2832-2011 | Boston Scientific, WALLSTENT" Endoprosthesis & WALLSTENT" RP Endoprosthesis, Self... | Boston Scientific Corporation | JCT |