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-1047-2011 | Omnifit M/S PSL Porous Coated Acetabular Shell 42MM; Stryker Orthopaedics, Uses in... | Howmedica Osteonics Corp | MEH | ||
| Z-1046-2011 | Omnifit M/S PSL Porous Coated Acetabular Shell 40MM; Stryker Orthopaedics, Uses in... | Howmedica Osteonics Corp | MEH | ||
| Z-2389-2010 | SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 Systems AQUA... | Siemens Healthcare Diagnostics Inc. | CGX | ||
| Z-2499-2010 | Liquid Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 1 mL liquid tissue... | Leica Microsystems, Inc. | NJT | ||
| Z-2498-2010 | Lyophilized Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 0.1 mL and 1 mL... | Leica Microsystems, Inc. | NJT | ||
| Z-2497-2010 | Bond Ready-To-Use Primary Antibody Thyroid Transcription Factor-1 (SPT24); 7 mL vial; an... | Leica Microsystems, Inc. | NJT | ||
| Z-0492-2011 | Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module | CareFusion 303, Inc | FRN | ||
| Z-2584-2010 | WECK IMA/ENT Blade Electrode (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical... | Teleflex Medical | GEI | ||
| Z-1924-2011 | Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software... | Quest Medical, Inc | DTR | ||
| Z-0087-2011 | Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the... | Theken Companies LLC | KWQ | ||
| Z-2638-2010 | Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT2: Latex Free, Rx... | Integra LifeSciences Corporation | LFL | ||
| Z-2637-2010 | Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT1:Latex Free, Rx... | Integra LifeSciences Corporation | LFL | ||
| Z-1606-2011 | MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring... | Fujirebio Diagnostics, Inc. | OAW | ||
| Z-1345-2013 | Class II | TD-Synergy. Laboratory Information System. | Technidata | JQP | |
| Z-2496-2010 | Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | ||
| Z-2495-2010 | Femoral Artery Catheterization Set | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQX | ||
| Z-2494-2010 | Arterial Catheterization Set | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQX | ||
| Z-2493-2010 | Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | ||
| Z-2492-2010 | Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | ||
| Z-2491-2010 | Multi-Lumen Pressure Injectable Central Venous Catheterization kit with Blue FlexTip... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | ||
| Z-2490-2010 | Multi-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | ||
| Z-2489-2010 | Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | ||
| Z-2488-2010 | MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | ||
| Z-2295-2010 | VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged... | bioMerieux, Inc. | LON | ||
| Z-2385-2011 | ***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218... | Biomet Microfixation | JEY | ||
| Z-2505-2010 | Modular Microplasty Cup impactor 1/4" - 28 thread insert , REF 31-400605 | Zimmer GmbH | LXH | ||
| Z-2504-2010 | Modular Microplasty Cup inserter 3/8" thread , REF 31-400600 | Zimmer GmbH | LXH | ||
| Z-0315-2011 | Distal Centralizer 10 mm | Ortho Development Corp. | KWY | ||
| Z-0133-2011 | Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Serial #'s: 2513, 2518... | Philips North America LLC | JAK | ||
| Z-0507-2012 | Microsoft Amalga Unified Intelligence System (UIS), This is a software-only device, WHIE... | Microsoft Corporation Health Solutions Group | JQP | ||
| Z-2383-2010 | 3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode... | 3M Company | DRX | ||
| Z-2652-2010 | Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO | Lumenis Ltd | HQF | ||
| Z-2596-2010 | MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF... | Hemostatix Medical Technologies, LLC | GEI | ||
| Z-2595-2010 | HEMOSTATIX HANDLE, FOR USE WITH MODELS 150 AND 600D HEMOSTATIX CONTROLLERS, REF... | Hemostatix Medical Technologies, LLC | GEI | ||
| Z-0040-2014 | Class II | Xoran MiniCAT00202 | Xoran Technologies, LLC | JAK | |
| Z-0039-2014 | Class II | Xoran Minicat00158 | Xoran Technologies, LLC | JAK | |
| Z-0038-2014 | Class II | Xoran Minicat00202 | Xoran Technologies, LLC | JAK | |
| Z-0037-2014 | Class II | Xoran MiniCAT CT Scanner | Xoran Technologies, LLC | JAK | |
| Z-0036-2014 | Class II | Xoran Mini CT Scanner | Xoran Technologies, LLC | JAK | |
| Z-0126-2011 | EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5 | Abbott Medical | DNN | ||
| Z-0122-2011 | in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test... | Bio-Rad Laboratories Inc. | LCP | ||
| Z-0431-2011 | Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part... | Siemens Healthcare Diagnostics Inc. | CDZ | ||
| Z-0489-2011 | CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology... | Abbott Medical | GKZ | ||
| Z-0130-2011 | AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240... | Advanced Medical Optics, Inc. | LPN | ||
| Z-0129-2011 | AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505... | Advanced Medical Optics, Inc. | LPN | ||
| Z-0121-2011 | EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2340-2010 | Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees; Sterile, TI Alloy, Implant... | Howmedica Osteonics Corp | HSB | ||
| Z-2583-2010 | SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique... | Synthes GmbH | MQP | ||
| Z-0017-2011 | Guidant, Vitality HE ICD, Model: T180DDR, Sterile Lot, Guidant Corporation, Cardiac... | Boston Scientific Corporation | KRG | ||
| Z-0016-2011 | Guidant, CONTAK RENEWAL 3/3RF Models H170, H175, H177, H179, H210, H215, H217, H219... | Boston Scientific Corporation | LWP |