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-0029-2007 | MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J. | FUJIFILM Healthcare Americas Corporation | LNH | ||
| Z-1530-06 | Allegiance Esmark 6' x 144' Bandage, Latex Free, Sterile; 36 bandages per case... | Intl. Medsurg Connection, Inc. | MHW | ||
| Z-1529-06 | Allegiance Esmark 6' x 108' Bandage, Latex Free, Sterile; 36 bandages per case... | Intl. Medsurg Connection, Inc. | MHW | ||
| Z-1528-06 | Allegiance Esmark 4' x 144' Bandage, Latex Free, Sterile; 36 bandages per case... | Intl. Medsurg Connection, Inc. | MHW | ||
| Z-1527-06 | Allegiance Esmark 4' x 108' Bandage, Latex Free, Sterile; 36 bandages per case... | Intl. Medsurg Connection, Inc. | MHW | ||
| Z-1303-06 | RUS Tool Version Software | GE Healthcare | JAA | ||
| Z-1302-06 | GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc. | GE Healthcare | JAA | ||
| Z-1301-06 | GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc. | GE Healthcare | JAA | ||
| Z-0254-2007 | Calstrux (Previously known as TCP Putty)- Absorbable Bone Void Filler, packaged... | Stryker Biotech | MQV | ||
| Z-1140-2007 | Femoral Speed Block Size 12, Part/Catalog #800-01-370; positioning device included as... | Encore Medical, LP | LKH | ||
| Z-1139-2007 | Femoral Speed Block Size 10, Part/Catalog #800-01-369; positioning device included as... | Encore Medical, LP | LKH | ||
| Z-1138-2007 | Femoral Speed Block Size 8, Part/Catalog #800-01-368; positioning device included as part... | Encore Medical, LP | LKH | ||
| Z-1137-2007 | Femoral Speed Block Size 6, Part/Catalog #800-01-367; positioning device included as part... | Encore Medical, LP | LKH | ||
| Z-1136-2007 | Femoral Speed Block Size 4 Part/Catalog #800-01-366; positioning device included as part... | Encore Medical, LP | LKH | ||
| Z-1135-2007 | Femoral Speed Block Size 2, Part/Catalog #800-01-365; positioning device included as part... | Encore Medical, LP | LKH | ||
| Z-0776-2007 | BacT/ALERT 3D 60 Systems Software, Blood Culturing System | bioMerieux, Inc. | MDB | ||
| Z-0775-2007 | BacT/ALERT 3D Combo Systems Software, Blood Culturing System | bioMerieux, Inc. | MDB | ||
| Z-0774-2007 | BacT/ALERT 3D System Software, Blood Culturing System | bioMerieux, Inc. | MDB | ||
| Z-0773-2007 | BacT/ALERT Classic System Software, Blood Culturing System | bioMerieux, Inc. | MDB | ||
| Z-0152-2007 | Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with... | FUJIFILM Healthcare Americas Corporation | MOS | ||
| Z-1524-06 | TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number... | Sybron Dental Specialties, Inc. | EMA | ||
| Z-0759-2007 | Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant). | Medi Mfg., Inc. | ISY | ||
| Z-0501-2007 | IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL)... | Abbott Medical | NRP | ||
| Z-0034-2007 | BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic... | Becton Dickinson & Co | JAK | ||
| Z-0046-2007 | Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C... | Abbott Medical | JOH | ||
| Z-1483-06 | Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters. | Cordis Neurovascular, Inc. | KRA | ||
| Z-1535-06 | NICO Model 7300 Cardiopulmonary Management System | Respironics Novametrix, LLC. | CCK | ||
| Z-1482-06 | Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters. | Cordis Neurovascular, Inc. | KRA | ||
| Z-0167-2007 | Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen... | Data Innovations, LLC | JQP | ||
| Z-0363-2007 | Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for... | Bock,Otto,Orthopedic Ind,Inc | KFX | ||
| Z-1499-06 | Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for... | Boston Scientific Corporation | GBW | ||
| Z-1484-06 | Alaris SE Pump (formerly Signature Edition Infusion Pump); Model Numbers: 7000, 7100... | CareFusion 303, Inc | FRN | ||
| Z-0021-2007 | GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE... | GE Healthcare | BSZ | ||
| Z-2457-2008 | Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The... | Cholestech Corp. | DCK | ||
| Z-0027-2007 | 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S... | 3M Company | JOJ | ||
| Z-0033-2007 | IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis) | AGFA Healthcare Corp. | LLZ | ||
| Z-0047-2007 | Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field... | Respironics, Inc. | CBK | ||
| Z-1697-2009 | Foot Choice Therapeutic Foot Massager, Model Number YS-322. The device is a heated... | Suarez Corporation Industries | ILY | ||
| Z-0100-2011 | SoftLab version 4.01 ASCII, ASCII Base 3.1.3.0-3.1.3.32, 3.1.4-3.1.4.27, 3.1.6-3.1.6.4... | SCC Soft Computer | LNX | ||
| Z-1516-06 | ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001. | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1491-06 | Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes... | LivaNova USA, Inc. | CAC | ||
| Z-1490-06 | Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes... | LivaNova USA, Inc. | CAC | ||
| Z-1489-06 | dideco Preassembled Surgical Wash Set, Electa Essential , Cobe part numbers WS55E... | LivaNova USA, Inc. | CAC | ||
| Z-1488-06 | dideco Preassembled Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C... | LivaNova USA, Inc. | CAC | ||
| Z-1452-06 | 7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc. | Medtronic CryoCath LP | LPB | ||
| Z-1534-06 | Codman External Drainage System 3 (EDS 3) CSF Without Ventricular Catheter Catalog... | Cerenovus, Inc. | |||
| Z-1533-06 | Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Numer... | Cerenovus, Inc. | |||
| Z-0055-2007 | GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major... | GE Healthcare | MHX | ||
| Z-0119-2007 | Michigan Instruments Thumper Mechanical CPR Device; Model 1007. | Michigan Instruments | DRM | ||
| Z-2460-2008 | Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic... | Cholestech Corp. | LCP |