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-0004-2017 | Class I | Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode... | Leonhard Lang GmbH | MKJ | |
| Z-0038-2017 | Class II | RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-0323-2017 | Class II | Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase... | Medtronic Navigation, Inc | GAH | |
| Z-0322-2017 | Class II | Visualase Visualization Stylets PN 020-2301. The individual components within the... | Medtronic Navigation, Inc | GAH | |
| Z-0876-2017 | Class II | NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous... | Neusoft Medical Systems Co., Ltd. | JAK | |
| Z-0875-2017 | Class II | NeuViz 64 Multi-slice CT Scanner Systems | Neusoft Medical Systems Co., Ltd. | JAK | |
| Z-2836-2016 | Class II | Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root... | Ormco/Sybronendo | KIF | |
| Z-2731-2016 | Class II | GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device. | GE Healthcare | LNH | |
| Z-0320-2017 | Class II | IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D)... | Siemens Healthcare Diagnostics Inc. | LKQ | |
| Z-0319-2017 | Class II | IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100... | Siemens Healthcare Diagnostics Inc. | LKQ | |
| Z-0728-2017 | Class II | Carry bar which is an accessory to a lift used for patients in hospitals and other... | Handicare USA, Inc. | FSA | |
| Z-0710-2017 | Class II | BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN #... | Boston Scientific Corporation | LJS | |
| Z-0709-2017 | Class II | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN #... | Boston Scientific Corporation | LJS | |
| Z-0708-2017 | Class II | Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits... | Boston Scientific Corporation | LJS | |
| Z-0351-2017 | Class II | Tandem (Tm) Intl Cocr Shell Uhmwpe Liner Bipolar, Ref Numbers: 71324038, 71324039... | Smith & Nephew, Inc. | KWY | |
| Z-0350-2017 | Class II | Tandem (Tm) Cocr Shell Uhmwpe Liner Bipolar, Ref Numbers: 71322040, 71322041... | Smith & Nephew, Inc. | KWY | |
| Z-0378-2017 | Class II | LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF... | Howmedica Osteonics Corp | JDI | |
| Z-2849-2016 | Class II | TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw... | Trimed Inc | HRS | |
| Z-0045-2017 | Class II | ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number... | Ldr Spine USA | LXH | |
| Z-0085-2017 | Class II | CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE... | ConMed Corporation | JOS | |
| Z-2840-2016 | Class II | G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2839-2016 | Class II | G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and... | The Anspach Effort, Inc. | HBE | |
| Z-2838-2016 | Class II | G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2837-2016 | Class II | G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and... | The Anspach Effort, Inc. | HBE | |
| Z-2864-2016 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is... | Advanced Medical Optics, Inc. | HQL | |
| Z-2863-2016 | Class II | TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is... | Advanced Medical Optics, Inc. | HQL | |
| Z-2862-2016 | Class II | TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No... | Advanced Medical Optics, Inc. | HQL | |
| Z-2861-2016 | Class II | TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The... | Advanced Medical Optics, Inc. | HQL | |
| Z-2860-2016 | Class II | SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the... | Advanced Medical Optics, Inc. | HQL | |
| Z-2859-2016 | Class II | TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated... | Advanced Medical Optics, Inc. | HQL | |
| Z-2858-2016 | Class II | TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the... | Advanced Medical Optics, Inc. | HQL | |
| Z-2857-2016 | Class II | TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated... | Advanced Medical Optics, Inc. | HQL | |
| Z-0044-2017 | Class I | Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients... | Teleflex Medical | JOH | |
| Z-2856-2016 | Class II | TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is... | Advanced Medical Optics, Inc. | HQL | |
| Z-2855-2016 | Class II | SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for... | Advanced Medical Optics, Inc. | HQL | |
| Z-2842-2016 | Class II | HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A | Philips North America LLC | MKJ | |
| Z-0051-2018 | Class II | United Nuclear Scientific High Power Handheld Lasers. Laser products | United Nuclear Scientific Supplies, LLC | REA | |
| Z-0402-2017 | Class III | Dimension IRON Flex reagent cartridges | Siemens Healthcare Diagnostics Inc. | JIY | |
| Z-0401-2017 | Class III | Dimension Vista IRON Flex reagent cartridges | Siemens Healthcare Diagnostics Inc. | JIY | |
| Z-2886-2016 | Class II | Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry... | GE Healthcare | MHX | |
| Z-0002-2017 | Class II | Merit Inflation Syringe Kit. Catalog Number KOS-02857 | Merit Medical Systems, Inc. | MAV | |
| Z-2851-2016 | Class III | Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium... | CooperSurgical, Inc. | MQL | |
| Z-2850-2016 | Class III | Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium... | CooperSurgical, Inc. | MQL | |
| Z-2885-2016 | Class II | Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit... | GE Healthcare | MHX | |
| Z-2866-2016 | Class II | Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine... | LivaNova USA, Inc. | DTQ | |
| Z-0056-2017 | Class II | The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers... | Natus Medical Incorporated | FMZ | |
| Z-0012-2017 | Class II | Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems... | Philips North America LLC | JAK | |
| Z-0011-2017 | Class II | Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems... | Philips North America LLC | JAK | |
| Z-0010-2017 | Class II | Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems... | Philips North America LLC | JAK | |
| Z-0009-2017 | Class II | Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems... | Philips North America LLC | JAK |