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-2796-2015 | Class II | 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number... | Orthopediatrics Corp | HRS | |
| Z-2733-2015 | Class II | Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the... | Siemens Healthcare Diagnostics Inc. | MSW | |
| Z-2483-2015 | Class II | Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. | Zimmer GmbH | LPH | |
| Z-2479-2015 | Class II | RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855... | Siemens Healthcare Diagnostics Inc. | KHP | |
| Z-2737-2015 | Class II | Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and... | Datascope Corp. | MHX | |
| Z-2804-2015 | Class II | The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica... | Leica Microsystems, Inc. | IEO | |
| Z-2729-2015 | Class II | Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow... | Transonic Systems Inc | DPW | |
| Z-2728-2015 | Class II | Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow... | Transonic Systems Inc | DPW | |
| Z-2727-2015 | Class II | Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow... | Transonic Systems Inc | DPW | |
| Z-2726-2015 | Class II | Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow... | Transonic Systems Inc | DPW | |
| Z-2725-2015 | Class II | Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow... | Transonic Systems Inc | DPW | |
| Z-2724-2015 | Class II | Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow... | Transonic Systems Inc | DPW | |
| Z-2723-2015 | Class II | Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow... | Transonic Systems Inc | DPW | |
| Z-2722-2015 | Class II | Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow... | Transonic Systems Inc | DPW | |
| Z-2721-2015 | Class II | Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow... | Transonic Systems Inc | DPW | |
| Z-2720-2015 | Class II | Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow... | Transonic Systems Inc | DPW | |
| Z-2432-2015 | Class III | Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology... | Cepheid | LSL | |
| Z-2739-2015 | Class II | ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare... | Siemens Healthcare Diagnostics Inc. | CGN | |
| Z-2431-2015 | Class III | Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number... | Cepheid | LSL | |
| Z-2467-2015 | Class II | Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO... | Sunrise Medical, Inc. | IOR | |
| Z-2466-2015 | Class II | Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO... | Sunrise Medical, Inc. | IOR | |
| Z-2357-2015 | Class II | Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The... | Hill-Rom Inc. | FSY | |
| Z-2356-2015 | Class II | Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The... | Hill-Rom Inc. | FSY | |
| Z-2355-2015 | Class II | Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual... | Hill-Rom Inc. | FSY | |
| Z-2354-2015 | Class II | Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual... | Hill-Rom Inc. | FSY | |
| Z-2353-2015 | Class II | Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The... | Hill-Rom Inc. | FSY | |
| Z-2459-2015 | Class II | CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 | Advanced Sterilization Products | MED | |
| Z-2420-2015 | Class II | Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver... | Medtronic Perfusion Systems | DWF | |
| Z-2543-2015 | Class II | cobas Liat Analyzer, for in vitro diagnostic use. | Roche Molecular Systems Inc | OCC | |
| Z-2551-2016 | Class II | Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image... | Merge Healthcare Incorporated | LLZ | |
| Z-2491-2015 | Class II | Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems | Philips North America LLC | OUO | |
| Z-0004-2016 | Class II | Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System. | Lifeline Systems, Inc. | ILQ | |
| Z-2450-2015 | Class II | Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The... | Siemens Healthcare Diagnostics Inc. | JZG | |
| Z-2718-2015 | Class II | Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total... | Volcano Corporation | PDU | |
| Z-2759-2015 | Class II | Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers... | Highridge Medical, LLC | KWP | |
| Z-2481-2015 | Class II | COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to... | Siemens Healthcare Diagnostics Inc. | GIF | |
| Z-2480-2015 | Class II | COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent... | Siemens Healthcare Diagnostics Inc. | GIF | |
| Z-2475-2015 | Class II | Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or... | Synthes (USA) Products LLC | JDQ | |
| Z-2442-2015 | Class II | Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic... | Medtronic, Inc. | MDS | |
| Z-0766-2016 | Class II | Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological... | Philips North America LLC | KPR | |
| Z-2542-2015 | Class II | CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10... | Wright Medical Technology Inc | HRS | |
| Z-2541-2015 | Class II | CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm... | Wright Medical Technology Inc | HRS | |
| Z-2730-2015 | Class II | Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary... | Spryson America Inc | GWN | |
| Z-2362-2015 | Class I | Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM... | CareFusion 303, Inc | FRN | |
| Z-2524-2015 | Class II | Neptune 2 Waste Management System Docking Station (120V and 230V), New and... | Stryker Corp. | FYD | |
| Z-2456-2015 | Class II | Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm... | Trilliant Surgical LLC | HTO | |
| Z-2464-2015 | Class II | Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw... | Trilliant Surgical LLC | HWC | |
| Z-2452-2015 | Class II | 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger... | Trilliant Surgical LLC | HTW | |
| Z-2421-2015 | Class II | 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated... | Trilliant Surgical LLC | HWC | |
| Z-2808-2015 | Class II | Marketing brochures for the PowerPICC and PowerPICC SOLO catheters | Bard Access Systems, Inc. | LJS |