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-1252-2018 | Class II | Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000... | Stryker Corp. | JDZ | |
| Z-1251-2018 | Class II | Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971... | Stryker Corp. | JDZ | |
| Z-1250-2018 | Class II | 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex... | Stryker Corp. | LOD | |
| Z-1249-2018 | Class II | PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI... | Stryker Corp. | OAR | |
| Z-1248-2018 | Class II | Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product... | Stryker Corp. | JDZ | |
| Z-1247-2018 | Class II | 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI... | Stryker Corp. | OAR | |
| Z-1246-2018 | Class II | 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100... | Stryker Corp. | FQH | |
| Z-1245-2018 | Class II | 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000... | Stryker Corp. | JDZ | |
| Z-1244-2018 | Class II | 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000... | Stryker Corp. | JDZ | |
| Z-1243-2018 | Class II | Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for... | Stryker Corp. | JDZ | |
| Z-1184-2018 | Class II | Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro... | Siemens Healthcare Diagnostics Inc. | JIX | |
| Z-1146-2018 | Class II | ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC... | Vascular Insights, LLC | KRA | |
| Z-1241-2019 | Class II | Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid... | C.R. Bard Inc | DWJ | |
| Z-1748-2018 | Class II | SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1747-2018 | Class II | SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1746-2018 | Class II | SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1745-2018 | Class II | SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0671-2018 | Class II | Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1... | Medtec LLC | JAI | |
| Z-0333-2018 | Class II | Philips Healthcare IQon Spectral CT computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-0332-2018 | Class II | Philips Healthcare Brilliance iCT SP computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-0331-2018 | Class II | Philips Healthcare Brilliance iCT computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-1013-2018 | Class III | T/Pump temperature therapy pump, Models TP700 and TP700C | Stryker Medical | ILO | |
| Z-0094-2018 | Class II | Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-0093-2018 | Class II | Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2111-2018 | Class II | Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer... | CareFusion 303, Inc | FPA | |
| Z-1892-2018 | Class II | Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in... | Southmedic Inc. | GDX | |
| Z-0686-2018 | Class II | Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description... | Boston Scientific Corporation | NIP | |
| Z-0382-2018 | Class II | Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product... | Owen Mumford USA, Inc. | FMI | |
| Z-0310-2018 | Class III | UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0309-2018 | Class III | Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0308-2018 | Class III | Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0685-2018 | Class II | Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description... | Boston Scientific Corporation | NIP | |
| Z-0381-2018 | Class II | Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product... | Owen Mumford USA, Inc. | FMI | |
| Z-2753-2018 | Class II | Handicare P600 Series Patient Lift Product Usage: A device used to lift and transport a... | Handicare USA, Inc. | FNL | |
| Z-2752-2018 | Class II | Handicare C Series Patient Lift Product Usage: A device used to lift and transport a... | Handicare USA, Inc. | FNL | |
| Z-1182-2018 | Class II | First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of... | Madison Polymeric Engineering | MNL | |
| Z-0991-2018 | Class II | ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product... | Bausch & Lomb Incorporated | LPL | |
| Z-0990-2018 | Class II | Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The... | Bausch & Lomb Incorporated | LPL | |
| Z-0989-2018 | Class II | Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Product... | Bausch & Lomb Incorporated | LPL | |
| Z-0988-2018 | Class II | Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product Usage: The... | Bausch & Lomb Incorporated | LPL | |
| Z-0987-2018 | Class II | Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The... | Bausch & Lomb Incorporated | LPL | |
| Z-0986-2018 | Class II | Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product Usage: The... | Bausch & Lomb Incorporated | LPL | |
| Z-0985-2018 | Class II | Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product Usage: The... | Bausch & Lomb Incorporated | LPL | |
| Z-0984-2018 | Class II | Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Product Usage: The... | Bausch & Lomb Incorporated | LPL | |
| Z-0983-2018 | Class II | Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Product... | Bausch & Lomb Incorporated | LPL | |
| Z-0982-2018 | Class II | NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The... | Bausch & Lomb Incorporated | LPL | |
| Z-0981-2018 | Class II | NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE... | Bausch & Lomb Incorporated | LPL | |
| Z-0504-2018 | Class II | bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight... | Becton Dickinson & Co | EMF | |
| Z-0503-2018 | Class II | bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product... | Becton Dickinson & Co | EMF | |
| Z-0502-2018 | Class II | bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215... | Becton Dickinson & Co | EMF |