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-0693-2019 | Class II | Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic... | GE Healthcare | LNH | |
| Z-0678-2019 | Class II | HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE | Howmedica Osteonics Corp | MQV | |
| Z-0677-2019 | Class II | HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE | Howmedica Osteonics Corp | MQV | |
| Z-0627-2019 | Class II | Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2... | Medtronic, Inc. | NEY | |
| Z-0626-2019 | Class II | Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2... | Medtronic, Inc. | NEY | |
| Z-0625-2019 | Class II | Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2... | Medtronic, Inc. | NEY | |
| Z-0614-2019 | Class II | Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390... | Philips North America LLC | DQK | |
| Z-1735-2019 | Class II | Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System... | Zimmer GmbH | KWP | |
| Z-0697-2019 | Class II | ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe... | SWISSRAY Medical, AG | MQB | |
| Z-0611-2019 | Class II | Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are reagent... | Diagnostica Stago, Inc. | GFO | |
| Z-0610-2019 | Class II | Staclot LA (REF 00600) The Staclot LA and Staclot LA 20 test kits are reagent systems... | Diagnostica Stago, Inc. | GFO | |
| Z-0723-2019 | Class II | Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | |
| Z-0670-2019 | Class II | NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50... | In2bones USA, LLC | JDR | |
| Z-0065-2020 | Class II | Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN... | Stryker Corp. | DQY | |
| Z-1388-2019 | Class II | EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical... | STRYKER Communications, Inc. | FSY | |
| Z-0865-2019 | Class I | Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics... | Rvo 2.0, Inc | LQE | |
| Z-0639-2019 | Class II | VITEK 2 Systems Software Version 9.01 Update Kit. | bioMerieux, Inc. | LON | |
| Z-0679-2019 | Class II | RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-0654-2019 | Class II | Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the... | Bracco Injeneering S.A. | DXT | |
| Z-0694-2020 | Class II | TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0... | Tekia Inc | HQL | |
| Z-0492-2020 | Class II | AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-0770-2019 | Class II | Perfusion Pack, Rx only, Sterile EO | LivaNova USA, Inc. | DWF | |
| Z-0641-2019 | Class II | Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software... | GE Healthcare | LLZ | |
| Z-0659-2019 | Class II | Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board... | Konica Minolta, Inc. | IXY | |
| Z-0619-2019 | Class II | SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List... | Abbott Medical | MRZ | |
| Z-0674-2020 | Class II | Philips Volcano FFR software used in the following systems connected to the McKesson... | Volcano Corporation | IYO | |
| Z-0493-2020 | Class II | Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245... | Hager & Meisinger GmbH | EJL | |
| Z-0612-2019 | Class II | Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary... | Philips Medical Systems DMC GmbH | JAA | |
| Z-0648-2019 | Class II | IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b)... | IMRIS Imaging, Inc. | FQO | |
| Z-0647-2019 | Class II | IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b)... | IMRIS Imaging, Inc. | FQO | |
| Z-0646-2019 | Class II | IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The... | IMRIS Imaging, Inc. | FQO | |
| Z-0645-2019 | Class II | IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d)... | IMRIS Imaging, Inc. | FQO | |
| Z-0604-2019 | Class II | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction... | The Binding Site Group Ltd. | CFN | |
| Z-0656-2019 | Class II | 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number... | Medtronic, Inc. | GCY | |
| Z-0551-2019 | Class II | Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138 | Mirion Technologies (Capintec), Inc. | IZD | |
| Z-0550-2019 | Class II | Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077 | Mirion Technologies (Capintec), Inc. | IZD | |
| Z-0628-2019 | Class II | enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary... | Bausch & Lomb Incorporated | HQL | |
| Z-0658-2019 | Class II | Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-0557-2019 | Class II | STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/tr... | Stephanix | OWB | |
| Z-0680-2019 | Class II | GEM Coupler Forceps, GEM4183C, packaged individually. | Baxter Healthcare Corporation | HTD | |
| Z-0486-2019 | Class II | Ascom Telligence Nurse Call System | Ascom (US) Inc. | IQA | |
| Z-0576-2019 | Class II | CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales... | CIVCO Medical Instruments Co., Inc. | ITX | |
| Z-0575-2019 | Class II | CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with... | CIVCO Medical Instruments Co., Inc. | ITX | |
| Z-0574-2019 | Class II | CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with... | CIVCO Medical Instruments Co., Inc. | ITX | |
| Z-0573-2019 | Class II | CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile... | CIVCO Medical Instruments Co., Inc. | ITX | |
| Z-0572-2019 | Class II | CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile... | CIVCO Medical Instruments Co., Inc. | ITX | |
| Z-0571-2019 | Class II | CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile... | CIVCO Medical Instruments Co., Inc. | ITX | |
| Z-0570-2019 | Class II | CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile... | CIVCO Medical Instruments Co., Inc. | ITX | |
| Z-0569-2019 | Class II | CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile... | CIVCO Medical Instruments Co., Inc. | ITX | |
| Z-0568-2019 | Class II | CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable... | CIVCO Medical Instruments Co., Inc. | ITX |