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-0124-2012 | SYNCHRON CX4 Clinical System Part #: 758300 Product Usage: The Beckman SYNCHRON CX4... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1737-2011 | diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of... | Diadexus, Inc. | NOE | ||
| Z-2462-2010 | GCX Mountable Downloader-Recharger; (accessory to the i-STAT Portable Clinical Analyzer... | Abbott Medical | CGA | ||
| Z-2642-2010 | Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with... | OLYMPUS Corporation of the Americas | GCJ | ||
| Z-1744-2011 | ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy... | Diasorin Inc. | LOM | ||
| Z-0139-2011 | Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on... | Siemens Healthcare Diagnostics Inc. | CEM | ||
| Z-0018-2011 | Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc... | Draeger Medical Systems, Inc. | CBK | ||
| Z-1115-2012 | Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC. Product Usage: The intended... | Sybron Dental Specialties, Inc. | EBF | ||
| Z-2169-2011 | Statspin Express 4 Centrifuge Model Number: SSH4 Intended Use: Rapid Separation of... | StatSpin, Inc., dba Iris Sample Processing | JQC | ||
| Z-0060-2011 | Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes... | Zimmer GmbH | LPH | ||
| Z-1075-2013 | Class III | G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal... | Tosoh Bioscience Inc | JPD | |
| Z-2588-2011 | Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number... | Kinamed Inc | KTT | ||
| Z-0507-2011 | Aimshot HeatSeeker Model HS3500, contains Class IIIb infared laser illuminator... | Amstech Incorporated | REP | ||
| Z-1838-2011 | ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular options... | Siemens Medical Solutions USA, Inc. | ITX | ||
| Z-1837-2011 | ACUSON S2000 ultrasound systems (all versions) with cardiovascular options... | Siemens Medical Solutions USA, Inc. | IYO | ||
| Z-1836-2011 | ACUSON and SONOLINE Antares and Antares PE ultrasound systems at product versions 4.0 and... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-2459-2010 | All Presource Kits that contain Medi-Vac Non-Conductive Suction Tube with Maxi-Grip... | Medtronic, Inc. | GAZ | ||
| Z-0098-2011 | Stryker PainPump2 blockAid 400 mL Painpump for continuous Nerve Block, REF 575-100... | Stryker Corp. | FRN | ||
| Z-0097-2011 | Stryker PainPump2 400 mL Painpump with Luer Lock Tubing Set, REF 540-350, Sterile, Rx... | Stryker Corp. | FRN | ||
| Z-0096-2011 | Stryker PainPump2 250 mL Painpump with Luer Lock Tubing Set, REF 525-350, Sterile, Rx... | Stryker Corp. | FRN | ||
| Z-2428-2010 | Safen' simple Ostomy Appliance Deodorant (8 oz , 1 oz package sizes) | Biomed Laboratories LLC | GDS | ||
| Z-2427-2010 | Genairex Securi-T Ostomy Deodorant (8 oz, 1 oz package sizes) | Biomed Laboratories LLC | GDS | ||
| Z-2426-2010 | Reliamed Odor Eliminator Drops (8 oz, 4 oz, 1 oz package sizes) | Biomed Laboratories LLC | GDS | ||
| Z-2458-2010 | Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm... | Medtronic, Inc. | GAZ | ||
| Z-2457-2010 | Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm... | Medtronic, Inc. | GAZ | ||
| Z-2456-2010 | Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm... | Medtronic, Inc. | GAZ | ||
| Z-2455-2010 | Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6 mm... | Medtronic, Inc. | GAZ | ||
| Z-2454-2010 | Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6 mm... | Medtronic, Inc. | GAZ | ||
| Z-2453-2010 | Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6 mm... | Medtronic, Inc. | GAZ | ||
| Z-2452-2010 | Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm... | Medtronic, Inc. | GAZ | ||
| Z-2451-2010 | Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm... | Medtronic, Inc. | GAZ | ||
| Z-2450-2010 | Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm... | Medtronic, Inc. | GAZ | ||
| Z-0480-2011 | GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating... | Becton Dickinson & Co | KZJ | ||
| Z-0086-2011 | R3 (TM) 28 MM I.D., 66/70 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF... | Smith & Nephew, Inc. | KWZ | ||
| Z-0085-2011 | R3 (TM) 28 MM I.D., 64 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF... | Smith & Nephew, Inc. | KWZ | ||
| Z-0084-2011 | R3 (TM) 28 MM I.D., 62 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF... | Smith & Nephew, Inc. | KWZ | ||
| Z-0083-2011 | R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF... | Smith & Nephew, Inc. | KWZ | ||
| Z-0082-2011 | R3 (TM) 22 MM I.D., 58 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF... | Smith & Nephew, Inc. | KWZ | ||
| Z-0081-2011 | R3 (TM) 22 MM I.D., 56 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF... | Smith & Nephew, Inc. | KWZ | ||
| Z-0080-2011 | R3 (TM) 22 MM I.D., 54 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF... | Smith & Nephew, Inc. | KWZ | ||
| Z-0079-2011 | R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF... | Smith & Nephew, Inc. | KWZ | ||
| Z-0907-2011 | ARTISTE and ONCOR Digital Linear Accelerators configured with the 160 leaf Multi-Leaf... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0607-2011 | Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0138-2011 | ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed... | Instrumentation Laboratory Co. | GKP | ||
| Z-0137-2011 | ACL TOP 700 LAS PN 000280030 Bench top, fully automated, random access analyzer designed... | Instrumentation Laboratory Co. | GKP | ||
| Z-0136-2011 | ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed... | Instrumentation Laboratory Co. | GKP | ||
| Z-0135-2011 | ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed... | Instrumentation Laboratory Co. | GKP | ||
| Z-1998-2011 | Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH... | Roche Diagnostics GmbH | MKW | ||
| Z-0478-2011 | The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is... | FUJIFILM SonoSite,Inc. | IYN | ||
| Z-2152-2011 | Allied Healthcare Products Inc. CarbO2Lime Carbon Dioxide Absorbent Granules for Canister... | Allied Medical LLC | CBL |