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-2603-2011 | Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho... | Ortho Development Corp. | MBL | ||
| Z-2740-2011 | NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic... | bioMerieux, Inc. | OOI | ||
| Z-2602-2011 | Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R, Ortho... | Ortho Development Corp. | MBL | ||
| Z-3118-2011 | Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single... | STERIS Corporation | MEC | ||
| Z-3193-2011 | Sterile Bone Cutting Burrs model SIL-7-9 labeled in part:***SIL-7-9***QTY: 1***9 mm... | The Anspach Effort, Inc. | HBC | ||
| Z-3192-2011 | Sterile Bone Cutting Burrs model S-5B-4 labeled in part:***S-5B-4***QTY: 1***5 mm Fluted... | The Anspach Effort, Inc. | HBC | ||
| Z-3191-2011 | Sterile Bone Cutting Burrs model QD8-4OVD labeled in part:***QD8-4OVD***QTY: 1***4 mm x... | The Anspach Effort, Inc. | HBC | ||
| Z-3190-2011 | Sterile Bone Cutting Burrs model M-6P labeled in part:***M-6P***QTY: 1***6 mm x 9 mm... | The Anspach Effort, Inc. | HBC | ||
| Z-3189-2011 | Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY... | The Anspach Effort, Inc. | HBC | ||
| Z-2632-2011 | 1500T14 Cardiac Ablation System - Remote Control The 1500Tl4 Remote Control can control... | Abbott Medical | |||
| Z-2631-2011 | 1500T14 Cardiac Ablation System - Generator The 1500Tl4 Cardiac Ablation System operates... | Abbott Medical | |||
| Z-2630-2011 | 1500T12 Cool Path Ablation System - Generator The generator is a... | Abbott Medical | |||
| Z-2755-2011 | Elevate System with IntePro Lite", Anterior and Apical Prolapse Repair System... | American Medical Systems, Inc. | FTL | ||
| Z-2669-2011 | AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only )... | American Medical Systems, Inc. | EZY | ||
| Z-2668-2011 | AMS Acticon Neosphincter Pump, Product Number 72402287, Sterilization Method Steam... | American Medical Systems, Inc. | MIP | ||
| Z-2676-2011 | Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-918-1, VBM... | VBM Medical Inc. | BTO | ||
| Z-2675-2011 | Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-914-1, VBM... | VBM Medical Inc. | BTO | ||
| Z-3125-2011 | Unicel DxH 800 Coulter Cellular Analysis System Product Usage: UniCel DxH 800 Coulter... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2657-2011 | Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire... | Arcadia Medical Corporation | BTO | ||
| Z-0200-2014 | Class II | Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor... | The Anspach Effort, Inc. | HBE | |
| Z-0199-2014 | Class II | Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor... | The Anspach Effort, Inc. | HSZ | |
| Z-0198-2014 | Class II | Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic... | The Anspach Effort, Inc. | HBC | |
| Z-0006-2012 | Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104... | LivaNova USA, Inc. | LYJ | ||
| Z-0005-2012 | VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103... | LivaNova USA, Inc. | LYJ | ||
| Z-3079-2011 | Elekta Synergy The Elekta Synergy System is intended to be used for radiation therapy... | Elekta Limited | |||
| Z-2732-2011 | DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number... | Smith & Nephew, Inc. | HAB | ||
| Z-2731-2011 | DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog... | Smith & Nephew, Inc. | HAB | ||
| Z-3254-2011 | Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray... | Deroyal Industries, Inc. Lafollette | HFX | ||
| Z-3253-2011 | DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO... | Deroyal Industries, Inc. Lafollette | HFX | ||
| Z-1124-2012 | GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is... | GE Healthcare | IZI | ||
| Z-3083-2011 | Fresenius 2008K@home The Fresenius 2008K@home is indicated for acute and chronic... | Fresenius Medical Care Renal Therapies Group, LLC | ONW | ||
| Z-2796-2011 | Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps... | Baxter Healthcare Corporation | FRN | ||
| Z-2563-2011 | GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager... | GE Healthcare | JQP | ||
| Z-2217-2011 | Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the... | Philips North America LLC | MHX | ||
| Z-0488-2012 | SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21... | SCC Soft Computer | JQP | ||
| Z-0277-2012 | SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. SoftLab... | SCC Soft Computer | LNX | ||
| Z-2621-2011 | Cardiovascular Procedure Kit, Part number 65871, Terumo Latin America Lactante Pack... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-2620-2011 | Cardiovascular Procedure Kit, Part number 65870, Terumo Latin America Pediatric Pack... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-2619-2011 | Cardiovascular Procedure Kit, Part number 65672-01, Terumo Latin America Seminsa... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-2618-2011 | Cardiovascular Procedure Kit, Part number 65418-01, Terumo Latin America Seminsa... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-2617-2011 | Cardiovascular Procedure Kit Part number 72427, Oklahoma Heart Hospital X-Coated System... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-2616-2011 | Cardiovascular Procedure Kit Part number 70367-07 Mission St. Joe's - Asheville X-Coated... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-2615-2011 | Cardiovascular Procedure Kit Part number 70667 Eisenhower Army Med Center Heart Lung... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-2614-2011 | Cardiovascular Procedure Kit Part number 70667-01 Eisenhower Army Med Center Heart Lung... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-2613-2011 | Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-2702-2011 | Eclipse Radiation Treatment Planning System, model H48; Varian Medical Systems Inc.. | Varian Medical Systems, Inc. | MUJ | ||
| Z-2412-2011 | DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured... | R4 Vascular, Inc. | MSD | ||
| Z-1645-2013 | Class II | Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920... | Braemar Manufacturing, LLC | DRG | |
| Z-2721-2011 | ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is... | Gentherm Medical, LLC | DWJ | ||
| Z-2720-2011 | ECMO Heater Model 333, Cardiopulmonary bypass temperature controller. This device is... | Gentherm Medical, LLC | DWJ |