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-1983-2014 | Class II | Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone... | The Anspach Effort, Inc. | HSZ | |
| Z-1705-2014 | Class II | Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and... | GE Healthcare | DSI | |
| Z-1997-2014 | Class II | Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code... | Medtronic, Inc. | CCX | |
| Z-1719-2014 | Class II | MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is... | ConMed Corporation | GEI | |
| Z-1838-2014 | Class II | G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip... | Zimmer GmbH | PBI | |
| Z-1837-2014 | Class II | G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip... | Zimmer GmbH | PBI | |
| Z-2647-2014 | Class II | Photonica Light Modulator. These include all products labeled as UltraSlim, Luxurian... | Photonica USA LLC | OLI | |
| Z-2646-2014 | Class II | Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo... | Photonica USA LLC | OLI | |
| Z-2645-2014 | Class II | Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo... | Photonica USA LLC | OLI | |
| Z-1840-2014 | Class II | Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1664-2014 | Class II | Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended... | Becton Dickinson & Co | HMX | |
| Z-0135-2016 | Class II | All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2... | Philips North America LLC | LNH | |
| Z-2121-2014 | Class II | Horizon Medical Imaging It is a medical image and information management application... | Change Healthcare Canada Company | LLZ | |
| Z-1646-2014 | Class II | Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a... | Philips North America LLC | OUG | |
| Z-2021-2014 | Class I | ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE... | Diabetic Supply of Suncoast, Inc. | CGA | |
| Z-1723-2014 | Class II | Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780... | Medtronic Neuromodulation | LKK | |
| Z-1727-2014 | Class II | Alere Triage D-Dimer Test PN 98100, Lot W53884B. The Alere Triage D-Dimer Test is a... | Alere San Diego, Inc. | GHH | |
| Z-1706-2014 | Class II | Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional... | GE Healthcare | KPY | |
| Z-1978-2014 | Class II | Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product... | Howmedica Osteonics Corp | LXH | |
| Z-1739-2014 | Class III | NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0665-2017 | Class II | Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from... | Merge Healthcare Incorporated | DQK | |
| Z-1508-2016 | Class II | Robotic Arm Interactive Orthopedic System (RIO) | Mako Surgical Corp. | OLO | |
| Z-0526-2015 | Class II | Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for... | Varian Medical Systems, Inc. | IYE | |
| Z-0135-2015 | Class II | HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6... | Abbott Medical | JJX | |
| Z-1712-2014 | Class II | PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic... | Microport Orthopedics Inc. | LXH | |
| Z-1662-2014 | Class II | IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character... | AGFA Healthcare Corp. | LLZ | |
| Z-1785-2014 | Class I | Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product... | ConvaTec Limited | KNT | |
| Z-1789-2014 | Class II | Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea... | Childrens Medical Ventures, LLC | NPF | |
| Z-1669-2014 | Class II | Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling... | Synthes GmbH | GFG | |
| Z-1661-2014 | Class II | Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG)... | Medtronic, Inc. | LWP | |
| Z-2246-2017 | Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit... | Baxter Healthcare Corporation | KDJ | |
| Z-1959-2014 | Class II | Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number... | Atrium Medical Corporation | CAC | |
| Z-1614-2014 | Class II | Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order... | Greatbatch Medical | DYB | |
| Z-2366-2015 | Class II | Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis... | FUJIFILM Healthcare Americas Corporation | MOS | |
| Z-1832-2014 | Class III | VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory... | Siemens Healthcare Diagnostics Inc. | LXG | |
| Z-1638-2014 | Class II | MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and... | Siemens Medical Solutions USA, Inc. | MUE | |
| Z-1806-2014 | Class II | RayStation software version 4.0.3.4 RayStation is a software system designed for... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-1674-2014 | Class II | BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is... | Artivion, Inc. | MUQ | |
| Z-1619-2014 | Class II | Revision K Actuator Test Boards sold as replacement parts for use with Fresenius... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1618-2014 | Class II | Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-0932-2015 | Class II | Baxter Amia Automated PD systems are used in the treatment of adult renal failure... | Baxter Healthcare Corporation | FKX | |
| Z-1729-2014 | Class II | HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610... | Cenorin, LLC | LDS | |
| Z-1663-2014 | Class II | MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance... | Siemens Medical Solutions USA, Inc. | LNH | |
| Z-1696-2014 | Class II | Bard Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1695-2014 | Class II | Bard Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1694-2014 | Class II | Bard Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1693-2014 | Class II | Bard Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1692-2014 | Class II | Bard Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1691-2014 | Class II | Bard Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1690-2014 | Class II | Bard Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ |