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-1227-2011 | Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis... | Merit Medical Systems, Inc. | DYB | ||
| Z-1226-2011 | Thomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with Integral... | Merit Medical Systems, Inc. | DYB | ||
| Z-1225-2011 | Thomas Medical Products, Y-Glide (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary... | Merit Medical Systems, Inc. | DTL | ||
| Z-1010-2011 | Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and... | Solta Medical, Inc. | ONG | ||
| Z-3018-2011 | i-CAT Classic (X-Ray Tube head and Power Supply) X-Ray imaging device that constructs a... | Dental Imaging Technologies Corporation | JAK | ||
| Z-1009-2011 | AutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5" Sterile REF SPM 35 Surgipro Flat... | Medtronic, Inc. | FTL | ||
| Z-1042-2011 | Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max... | Medtronic Navigation, Inc | HAW | ||
| Z-1731-2011 | Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1730-2011 | Coulter HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader. Hematology... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1605-2011 | Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic... | Philips North America LLC | IXL | ||
| Z-1604-2011 | Philips BV Endura, Rel. 2, 718074. Mobile C-Arm X-Ray systems offering Radiographic and... | Philips North America LLC | IXL | ||
| Z-1603-2011 | Philips BV Libra, Mobile X-ray unit, 718022. Mobile C-Arm X-Ray systems offering... | Philips North America LLC | IZL | ||
| Z-0932-2011 | 4D Integrated Treatment Console (4DITC); All versions up to and including 8.8.17 Varian... | Varian Medical Systems, Inc. | IYE | ||
| Z-1477-2011 | ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows: Product code... | Siemens Healthcare Diagnostics Inc. | LTK | ||
| Z-0875-2012 | ***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit... | Smith & Nephew, Inc. | OMP | ||
| Z-0966-2011 | Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050. | Cook Incorporated | KOD | ||
| Z-0742-2012 | New Label: EtchMaster ***Cordless Handpiece***P/N 797 www.GromanDental.com 1800-906-9298... | Groman Inc. | KOJ | ||
| Z-1669-2011 | Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands... | Philips North America LLC | KPS | ||
| Z-1045-2011 | Varian High Energy Linear Accelerator: Varian Medical Systems, Palo Alto, CA... | Varian Medical Systems, Inc. | IYE | ||
| Z-0865-2011 | Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number... | Bard Access Systems, Inc. | LJS | ||
| Z-1591-2011 | Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size... | Anchor Products Co. | GCJ | ||
| Z-1590-2011 | Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size... | Anchor Products Co. | GCJ | ||
| Z-0269-2013 | Class II | TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product... | Alphatec Spine, Inc. | KWP | |
| Z-2674-2011 | Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. The Spectra... | Terumo BCT, Ltd | LKN | ||
| Z-0954-2011 | Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537... | Medtronic, Inc. | GEI | ||
| Z-1488-2012 | BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles... | Bomimed Inc | EQN | ||
| Z-3221-2011 | TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed. | Canon Medical Systems USA, Inc. | JAK | ||
| Z-1593-2011 | Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and... | Maquet Cardiovascular LLC | DSY | ||
| Z-1680-2011 | Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number 20767174322... | Roche Diagnostics GmbH | LDP | ||
| Z-1679-2011 | Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche... | Roche Diagnostics GmbH | LDP | ||
| Z-0895-2011 | Disc Space Distractor Label states - Specialty Disc Space Distractor, Mfg by: Stryker... | Howmedica Osteonics Corp | LXH | ||
| Z-1018-2011 | Port/PICC Access Kit, Reorder CV13240, Sterile, Centurion Medical Products Corp... | Centurion Medical Products, LP | LRS | ||
| Z-1017-2011 | Port Dressing Tray, Reorder DT12885, Sterile, Centurion Medical Products Corp... | Centurion Medical Products, LP | LRS | ||
| Z-1016-2011 | Minor Dressing Tray, Reorder DT14405, Sterile, Centurion Medical Products Corp... | Centurion Medical Products, LP | LRS | ||
| Z-1015-2011 | Port Blood Draw Tray "for use with power ports", Reorder DT9410C, Sterile, Centurion... | Centurion Medical Products, LP | LRS | ||
| Z-1014-2011 | Port Access Tray "for use with power ports" Reorder DT9405C, Sterile, Centurion... | Centurion Medical Products, LP | LRS | ||
| Z-1013-2011 | VAD Kit Reorder DT8915, Sterile, Centurion Medical Products Corp. Williamston... | Centurion Medical Products, LP | LRS | ||
| Z-1254-2011 | Flexicair MC3 (Model number: M4000) Low Airloss Therapy Units For use to prevent pressure... | Hill-Rom Manufacturing, Inc. | IOQ | ||
| Z-1253-2011 | Flexicair II (Model number 13000) Low Airloss Therapy Units For use to prevent pressure... | Hill-Rom Manufacturing, Inc. | IOQ | ||
| Z-0894-2011 | Blood Center Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder... | Continental Medical Labs,Inc | OFM | ||
| Z-1948-2011 | DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing... | DePuy Mitek, Inc. | HBX | ||
| Z-1422-2011 | Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0992-2011 | Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates... | Edwards Lifesciences LLC | DWF | ||
| Z-0991-2011 | EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO... | Edwards Lifesciences LLC | DWF | ||
| Z-1341-2011 | Celite ACT Cartridge Cartridge is useful for monitoring patients receiving heparin for... | Abbott Medical | JBP | ||
| Z-1947-2011 | DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy... | DePuy Mitek, Inc. | HBX | ||
| Z-1946-2011 | DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy... | DePuy Mitek, Inc. | HBX | ||
| Z-1245-2011 | GE Centricity Laboratory software; GE Healthcare IT, Barrington, IL 60010. The intended... | GE Healthcare | JQP | ||
| Z-2839-2011 | Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis... | Therakos Inc | LNR | ||
| Z-0883-2011 | Occluder module, catalog 803480, Terumo Cardiovascular System Corp, Ann Arbor, MI. The... | Terumo Cardiovascular Systems Corporation | DTQ |