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-0157-2016 | Class II | Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number... | Smith & Nephew, Inc. | HWE | |
| Z-0156-2016 | Class II | Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number... | Smith & Nephew, Inc. | HWE | |
| Z-0155-2016 | Class II | Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number... | Smith & Nephew, Inc. | HWE | |
| Z-0109-2016 | Class II | MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus... | Siemens Healthcare Diagnostics Inc. | LTT | |
| Z-0108-2016 | Class II | MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus... | Siemens Healthcare Diagnostics Inc. | LTT | |
| Z-0003-2016 | Class II | SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and... | Biosense Webster Inc | OBJ | |
| Z-0002-2016 | Class II | Carto 3 EP Navigation System. Electro physiology system which views of the electrical... | Biosense Webster Inc | DQK | |
| Z-2782-2015 | Class II | Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical... | Intuitive Surgical, Inc. | NAY | |
| Z-0163-2016 | Class II | ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic... | Abbott Medical | JJE | |
| Z-0222-2016 | Class II | Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine... | Howmedica Osteonics Corp | LXH | |
| Z-0261-2016 | Class II | Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component. | Howmedica Osteonics Corp | LPH | |
| Z-0252-2016 | Class II | Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml... | Biocare Medical LLC | NJT | |
| Z-0111-2016 | Class II | Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod... | Depuy Orthopaedics Inc. | LXH | |
| Z-0285-2016 | Class II | Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight... | Handicare USA, Inc. | FSA | |
| Z-0284-2016 | Class II | Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and... | Handicare USA, Inc. | FSA | |
| Z-1719-2016 | Class II | Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System | Philips North America LLC | JAK | |
| Z-1718-2016 | Class II | Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System | Philips North America LLC | JAK | |
| Z-1717-2016 | Class II | Philips Healthcare Ingenuity CT Computed Tomography X-Ray System | Philips North America LLC | JAK | |
| Z-1716-2016 | Class II | Philips Healthcare Ingenuity Core Computed Tomography X-Ray System | Philips North America LLC | JAK | |
| Z-1715-2016 | Class II | Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System | Philips North America LLC | JAK | |
| Z-1714-2016 | Class II | Philips Healthcare Brilliance iCT Computed Tomography X-Ray System | Philips North America LLC | JAK | |
| Z-1713-2016 | Class II | Philips Healthcare Brilliance 64 Computed Tomography X-Ray System | Philips North America LLC | JAK | |
| Z-1572-2016 | Class II | ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-0120-2016 | Class II | -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and... | Medtronic, Inc. | OUT | |
| Z-0220-2016 | Class II | EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High... | Agilent Technologies, Inc. | LDT | |
| Z-0134-2016 | Class II | 5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm... | Synthes (USA) Products LLC | MNI | |
| Z-1077-2017 | Class II | Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for... | Roche Diagnostics GmbH | CHL | |
| Z-0341-2016 | Class II | Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in... | Leica Microsystems, Inc. | NJT | |
| Z-0435-2016 | Class II | AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm... | Summit Medical, LLC | LRD | |
| Z-0210-2016 | Class III | AMSCO 400 and AMSCO C Small Steam Sterilizers | STERIS Corporation | FLE | |
| Z-0172-2016 | Class II | Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4... | GE Healthcare | DXH | |
| Z-0206-2016 | Class II | BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS... | Bausch & Lomb Incorporated | LPL | |
| Z-0125-2016 | Class II | Inserter for Titanium Elastic Nails (TEN), orthopedic device | Synthes (USA) Products LLC | LXH | |
| Z-0119-2016 | Class II | Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail... | Zimmer GmbH | HSB | |
| Z-0283-2016 | Class II | IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x... | AGFA Healthcare Corp. | LLZ | |
| Z-2777-2015 | Class II | Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac... | Medtronic, Inc. | LPB | |
| Z-0105-2016 | Class III | CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical... | CooperSurgical, Inc. | HEE | |
| Z-0260-2016 | Class II | GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines... | GE Healthcare | OUO | |
| Z-0259-2016 | Class II | GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa... | GE Healthcare | LNH | |
| Z-0258-2016 | Class II | GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body... | GE Healthcare | LNH | |
| Z-0257-2016 | Class II | GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an... | GE Healthcare | LNH | |
| Z-0256-2016 | Class II | GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device. | GE Healthcare | LNH | |
| Z-0255-2016 | Class II | GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic... | GE Healthcare | LNH | |
| Z-0254-2016 | Class II | GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T... | GE Healthcare | LNH | |
| Z-0418-2016 | Class II | Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT... | FUJIFILM Healthcare Americas Corporation | FDT | |
| Z-0148-2016 | Class II | ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US)... | ConforMIS, Inc. | NPJ | |
| Z-0130-2016 | Class II | XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer... | Elekta Limited | MUJ | |
| Z-0147-2016 | Class II | ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT... | ConforMIS, Inc. | JWH | |
| Z-0146-2016 | Class II | ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number... | ConforMIS, Inc. | JWH | |
| Z-0145-2016 | Class II | ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left... | ConforMIS, Inc. | JWH |