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-2786-2011 | Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System Nuclear magnetic... | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-2566-2011 | Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular... | Roche Molecular Systems Inc | NPQ | ||
| Z-2565-2011 | Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for... | Roche Molecular Systems Inc | JPF | ||
| Z-2994-2011 | XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001... | Therakos Inc | LNR | ||
| Z-2775-2011 | Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-4 The... | Siemens Healthcare Diagnostics Inc. | ndr | ||
| Z-2774-2011 | Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-4 The... | Siemens Healthcare Diagnostics Inc. | ndr | ||
| Z-2773-2011 | Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-1 The... | Siemens Healthcare Diagnostics Inc. | ndr | ||
| Z-2772-2011 | Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-1 The... | Siemens Healthcare Diagnostics Inc. | ndr | ||
| Z-2184-2011 | IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916... | Siemens Healthcare Diagnostics Inc. | CFL | ||
| Z-2200-2011 | Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, Manufactured and... | Varian Medical Systems, Inc. | IYE | ||
| Z-2138-2011 | SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged... | Surgical Specialties Corp | DTH | ||
| Z-1224-2012 | Hamamatsu Corporation, Bridgewater NJ 08807 Microfocus X-ray Source L8601 series, L9121... | Hamamatsu Corp. | RBS | ||
| Z-2291-2011 | LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare... | Baxter Healthcare Corporation | LHI | ||
| Z-2150-2011 | Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-2195-2011 | Varian brand Clinac, Medical Linear Accelerator, All Varian Clinac with Model Numbers... | Varian Medical Systems, Inc. | IYE | ||
| Z-2419-2011 | Boston Scientific, Atlantis SR Pro 2, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x... | Boston Scientific Corporation | DQO | ||
| Z-2156-2011 | Brightview XCT, 3/4" Philips Medical Systems Brightview XCT is a gamma camera for... | Philips North America LLC | KPS | ||
| Z-2155-2011 | Brightview XCT, 3/8" Philips Medical Systems Brightview XCT is a gamma camera for... | Philips North America LLC | KPS | ||
| Z-2027-2011 | Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110... | Abbott Medical | KDC | ||
| Z-2026-2011 | Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 99 Inch with Drip Chamber... | Abbott Medical | KDC | ||
| Z-2025-2011 | Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 100 Inch with Clave and... | Abbott Medical | KDC | ||
| Z-2024-2011 | Hospira Latex-Free Blood Secondary Set, 26 Inch with Secure Lock; a sterile Rx tubing set... | Abbott Medical | KDC | ||
| Z-2890-2011 | BD BACTEC(tm) MGI (tm) System Software, Catalog 445922, Lot V5.02A. Product Usage: The... | Becton Dickinson & Co | MDB | ||
| Z-2418-2011 | Boston Scientific iCross, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, REF... | Boston Scientific Corporation | DQO | ||
| Z-2062-2011 | S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471. The... | Philips Medical Systems Nederland B.V. | IYN | ||
| Z-2183-2011 | TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote... | Remote Diagnostic Technologies Ltd. | MWI | ||
| Z-0112-2012 | Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube... | Salter Labs | BYF | ||
| Z-0111-2012 | Mask adult, oxygen, medium concentration, elastic strap style, w/9' tube - 50/cs; Salter... | Salter Labs | BYG | ||
| Z-0110-2012 | Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/9' tube... | Salter Labs | BYG | ||
| Z-0109-2012 | Mask adult, oxygen, medium concentration, elastic strap style w. 7' tube (Linde)... | Salter Labs | BYG | ||
| Z-0108-2012 | Nebulizer (adult elastic strap style aerosol mask 7' tube - 50/cs), Latex Free Salter... | Salter Labs | CCQ | ||
| Z-2236-2011 | Micro Stream Filterline Infant/Neonatal products: Part # 010807 - VlTALINE H SET... | Oridion Medical 1987 Ltd. | CCK | ||
| Z-2235-2011 | MicroStream Filterline Infant/Neonatal products: Part # 008598 - FILTERLINE H SET INF/NEO... | Oridion Medical 1987 Ltd. | CCK | ||
| Z-2234-2011 | MicroStream Filterline Infant/Neonatal products: Part # 006324 - FILTERLINE H SET INF/NEO... | Oridion Medical 1987 Ltd. | CCK | ||
| Z-2233-2011 | MicroStream Filterline Infant/Neonatal products: Part # 006285 - FILTERLINE H SET INF/NEO... | Oridion Medical 1987 Ltd. | CCK | ||
| Z-2048-2011 | Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | ||
| Z-1148-2014 | Class II | GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW... | GE Healthcare | JAK | |
| Z-0271-2012 | TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA... | Salter Labs | KNT | ||
| Z-0319-2012 | Stereotactic Circular Collimator Product Usage: This device is intended to hold a... | Elekta Limited | HAW | ||
| Z-2293-2011 | syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. The... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-2190-2011 | ARTISTE / RT Therapist v4.1 system. The ONCOR and PRIMUS system may be updated to utilize... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2122-2011 | Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare... | Baxter Healthcare Corporation | FRN | ||
| Z-2134-2011 | Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models... | GE Healthcare | MHX | ||
| Z-2133-2011 | Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating... | Robling Medical, LLC | OHR | ||
| Z-0191-2013 | Class III | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor... | Clinical Diagnostic Solutions, Inc. | JPK | |
| Z-0190-2013 | Class III | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor... | Clinical Diagnostic Solutions, Inc. | JPK | |
| Z-0189-2013 | Class III | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor... | Clinical Diagnostic Solutions, Inc. | JPK | |
| Z-2760-2011 | J-Vac Drain Adaptor Manufactured for: Ethicon, Inc. Somerville, New Jersey... | Ethicon, Inc | KOG | ||
| Z-2759-2011 | Blake Cardio Connector 1 unit, Manufactured for: Ethicon, Inc. Somerville, New Jersey... | Ethicon, Inc | KOG | ||
| Z-2758-2011 | J-Vac Bulb Suction Reservoir, Manufactured for: Ethicon, Inc. Somerville, New Jersey... | Ethicon, Inc | KOG |