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-0885-2017 | Class II | IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay... | Siemens Healthcare Diagnostics Inc. | MTF | |
| Z-0884-2017 | Class II | IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number... | Siemens Healthcare Diagnostics Inc. | MTF | |
| Z-0879-2017 | Class III | OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw | Orthopediatrics Corp | HSB | |
| Z-0764-2017 | Class II | WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC... | Teleflex Medical | GDT | |
| Z-0943-2017 | Class II | PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics... | Microport Orthopedics Inc. | LZO | |
| Z-0704-2017 | Class II | UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT... | Ultradent Products Inc. | EBC | |
| Z-0668-2017 | Class II | Monaco TRP System The Monaco system is used to make treatment plans for patients with... | Elekta Limited | MUJ | |
| Z-1883-2017 | Class II | SmartSite Add-On Bag Access Device, Model No. 10013365 | CareFusion 303, Inc | FPA | |
| Z-0826-2017 | Class II | Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion... | Medtronic, Inc. | DTZ | |
| Z-0750-2017 | Class II | LightMix Zika rRT-PCR Test The LightMix Zika rRT-PCR Test is a real-time RT-PCR test... | Roche Molecular Systems Inc | POA | |
| Z-1008-2017 | Class II | REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew... | Smith & Nephew, Inc. | JDI | |
| Z-0779-2017 | Class III | DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum | Revvity Health Sciences, Inc. | CGJ | |
| Z-0759-2017 | Class II | Weck Facial Closure Systems have application in laparoscopic procedures for... | Teleflex Medical | HCF | |
| Z-1920-2018 | Class II | ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The... | Implant Direct Sybron Manufacturing LLC | DZE | |
| Z-0946-2017 | Class II | Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for... | Smith & Nephew, Inc. | MEH | |
| Z-0945-2017 | Class II | Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for... | Smith & Nephew, Inc. | MEH | |
| Z-0744-2017 | Class II | SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0944-2017 | Class II | Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems... | Smith & Nephew, Inc. | MEH | |
| Z-0743-2017 | Class II | SOMATOM Definition Flash System, x-ray, tomography, computed Intended to produce... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0742-2017 | Class II | SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0896-2017 | Class II | SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse... | Busse Hospital Disposables | FSM | |
| Z-0895-2017 | Class II | BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse... | Busse Hospital Disposables | FCH | |
| Z-0894-2017 | Class II | CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only... | Busse Hospital Disposables | LXH | |
| Z-0711-2017 | Class II | Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants... | Encore Medical, LP | JWH | |
| Z-0706-2017 | Class II | Philips Spectral CT Applications supports viewing and analysis of images at energies... | Philips North America LLC | JAK | |
| Z-0705-2017 | Class II | IQon Spectral CT is a Computed Tomography X-Ray System intended to produce... | Philips North America LLC | JAK | |
| Z-0749-2017 | Class II | Cellfina Prep Pack, Part No. CP1 | Merz North America, Inc. | OUP | |
| Z-0697-2017 | Class II | Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cross-sectional... | Philips North America LLC | JAK | |
| Z-0696-2017 | Class II | Ingenuity Core 128 728323 | Philips North America LLC | JAK | |
| Z-0695-2017 | Class II | Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce... | Philips North America LLC | JAK | |
| Z-0694-2017 | Class II | Brilliance 64 728232 Computed Tomography X-ray systems intended to produce... | Philips North America LLC | JAK | |
| Z-0693-2017 | Class II | Brilliance 64 728231 Computed Tomography X-ray systems intended to produce... | Philips North America LLC | JAK | |
| Z-2781-2017 | Class II | ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 | Greatbatch Medical | DYB | |
| Z-1042-2017 | Class II | Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx... | Smith & Nephew, Inc. | OMP | |
| Z-1041-2017 | Class II | Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for... | Smith & Nephew, Inc. | OMP | |
| Z-0765-2017 | Class II | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars... | Stryker Sustainability Solutions | NLM | |
| Z-0892-2017 | Class II | ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA... | Medtronic, Inc. | LIT | |
| Z-0722-2017 | Class III | Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is... | OraSure Technologies, Inc. | DIS | |
| Z-0758-2017 | Class II | Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile. | Halyard Health | LZA | |
| Z-0880-2017 | Class II | GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma... | Howmedica Osteonics Corp | NDE | |
| Z-0721-2017 | Class II | RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-0724-2017 | Class II | Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code... | Halyard Health | KKX | |
| Z-0698-2017 | Class II | Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics... | Elana, Inc. | PAX | |
| Z-0719-2017 | Class II | Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY... | Ivoclar Vivadent, Inc. | ELW | |
| Z-0718-2017 | Class II | Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code... | Ivoclar Vivadent, Inc. | ELW | |
| Z-0717-2017 | Class II | Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461... | Ivoclar Vivadent, Inc. | ELW | |
| Z-0573-2020 | Class II | CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001 | Wright Medical Technology Inc | HRS | |
| Z-0572-2020 | Class II | SWANSON TRAPEZIUM IMPLANT, Part Number 4520002 | Wright Medical Technology Inc | KYI | |
| Z-0571-2020 | Class II | SWANSON FINGER JOINT #2, Part Number 4700002 | Wright Medical Technology Inc | KYJ | |
| Z-0570-2020 | Class II | SWANSON FINGER JOINT #1, Part Number 4700001 | Wright Medical Technology Inc | KYJ |