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-2126-2015 | Class II | WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard" gamma... | Revvity Health Sciences, Inc. | JJJ | |
| Z-2125-2015 | Class II | WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard" gamma counter is... | Revvity Health Sciences, Inc. | JJJ | |
| Z-2124-2015 | Class II | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard" gamma... | Revvity Health Sciences, Inc. | JJJ | |
| Z-2102-2015 | Class II | Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker... | Stryker Corp. | KNW | |
| Z-2105-2015 | Class II | EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product... | ArthroCare Corporation | GEI | |
| Z-1817-2015 | Class II | CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using... | Boston Scientific Corporation | DRQ | |
| Z-1940-2015 | Class II | Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous... | Alcon Laboratories | HQC | |
| Z-1939-2015 | Class II | Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H... | Sechrist Industries Inc | FPO | |
| Z-1965-2015 | Class II | Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant... | Hamilton Medical AG | BZO | |
| Z-1964-2015 | Class II | Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant... | Hamilton Medical AG | BZO | |
| Z-1963-2015 | Class II | Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant... | Hamilton Medical AG | BZO | |
| Z-1836-2015 | Class II | Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for... | Stryker Sustainability Solutions | NLM | |
| Z-1835-2015 | Class II | Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated... | Stryker Sustainability Solutions | NLM | |
| Z-1834-2015 | Class II | Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for... | Stryker Sustainability Solutions | NLM | |
| Z-2370-2015 | Class I | HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only... | Teleflex Medical | CBI | |
| Z-2369-2015 | Class I | HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate... | Teleflex Medical | CBI | |
| Z-2368-2015 | Class I | HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35... | Teleflex Medical | CBI | |
| Z-2367-2015 | Class I | HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35... | Teleflex Medical | CBI | |
| Z-1719-2015 | Class II | Laksell GammaPlan, a computer based dose planning system specifically designed for use... | Elekta Limited | IWB | |
| Z-1203-2017 | Class II | The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a... | Merge Healthcare Incorporated | DQK | |
| Z-2389-2015 | Class II | Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of... | Howmedica Osteonics Corp | MBH | |
| Z-2360-2015 | Class II | Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19... | Howmedica Osteonics Corp | JWH | |
| Z-1985-2015 | Class II | GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic... | GE Healthcare | IZI | |
| Z-1984-2015 | Class II | GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic... | GE Healthcare | IZI | |
| Z-1983-2015 | Class II | GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generating fluoroscopic... | GE Healthcare | IZI | |
| Z-1982-2015 | Class II | GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generating fluoroscopic... | GE Healthcare | IZI | |
| Z-1981-2015 | Class II | GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic... | GE Healthcare | IZI | |
| Z-1980-2015 | Class II | GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic... | GE Healthcare | IZI | |
| Z-1979-2015 | Class II | GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating fluoroscopic... | GE Healthcare | IZI | |
| Z-1978-2015 | Class II | GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic... | GE Healthcare | IZI | |
| Z-1977-2015 | Class II | GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic... | GE Healthcare | IZI | |
| Z-1976-2015 | Class II | GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic... | GE Healthcare | IZI | |
| Z-1975-2015 | Class II | GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray... | GE Healthcare | OWB | |
| Z-1974-2015 | Class II | GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generating... | GE Healthcare | IZI | |
| Z-1973-2015 | Class II | GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic... | GE Healthcare | IZI | |
| Z-2785-2015 | Class II | Radiation Therapy Treatment Planning System software RayStation is a software system... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2053-2015 | Class II | Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | JDQ | |
| Z-1959-2015 | Class II | ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-2209-2015 | Class II | InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate... | Skeletal Kinetics, LLC | MQV | |
| Z-1796-2015 | Class II | ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance... | Mortara Instrument, Inc. | DPS | |
| Z-1745-2015 | Class II | AGFA DX-D 100 is a mobile digital radiography x-ray system | AGFA Healthcare Corp. | IZL | |
| Z-1971-2015 | Class II | Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a... | Tecan U.S. | KHO | |
| Z-1970-2015 | Class II | Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a... | Tecan U.S. | KHO | |
| Z-1990-2015 | Class II | The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended... | Maquet Cardiovascular Us Sales, LLC | FSY | |
| Z-1969-2015 | Class II | Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a... | Tecan U.S. | KHO | |
| Z-1968-2015 | Class II | Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is... | Tecan U.S. | KHO | |
| Z-1967-2015 | Class II | Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a... | Tecan U.S. | KHO | |
| Z-0227-2016 | Class II | Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model... | Barco, Inc | KQM | |
| Z-2187-2015 | Class II | Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2186-2015 | Class II | Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX |