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-1917-2009 | Triathlon MIS 4:1 Cutting Blocks - Size 1-8; Catalog Numbers: 6541-5-701, 6541-5-702... | Howmedica Osteonics Corp | LXH | ||
| Z-1916-2009 | Triathlon AR 4:1 Cutting Blocks - Size 1-8; Catalog Numbers: 6541-0-701, 6541-0-702... | Howmedica Osteonics Corp | LXH | ||
| Z-0800-2007 | 3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade... | 3M ESPE Dental Products | EBF | ||
| Z-0733-2007 | Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is... | Bio-Rad Laboratories Inc. | DKZ | ||
| Z-2113-2011 | Doctors Review System, OB-Windows/OB-View software release numbers 4.1 through 4.1.3... | Digisonics, Inc | LLZ | ||
| Z-1129-2007 | Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets. | Curlin Medical LLC | FPA | ||
| Z-0559-2007 | OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System, | GE Healthcare | JAA | ||
| Z-0558-2007 | OEC 9800 Plus Fluoroscopic X-ray System, | GE Healthcare | JAA | ||
| Z-0557-2007 | OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System, | GE Healthcare | JAA | ||
| Z-0789-2007 | AMS 700 LGX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15... | American Medical Systems, Inc. | JCW | ||
| Z-0788-2007 | AMS 700 CX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15... | American Medical Systems, Inc. | JCW | ||
| Z-0787-2007 | AMS 700 CX Preconnected penile Prosthesis with InhibiZone, product length 18 cm, product... | American Medical Systems, Inc. | JCW | ||
| Z-0786-2007 | AMS 700 CX MS Pump IZ Preconnected penile Prosthesis, product length 18 cm, product... | American Medical Systems, Inc. | JCW | ||
| Z-0785-2007 | AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm... | American Medical Systems, Inc. | JCW | ||
| Z-0556-2007 | OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery. | GE Healthcare | JAA | ||
| Z-0577-2007 | EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters... | EKOS Corporation | KRA | ||
| Z-0626-2007 | HoMedics Thera P Model King size Moist/Dry Heating Pad with Auto Shut-off; Model No... | FKA Distributing Co., LLC | IRT | ||
| Z-0766-2007 | Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior Vitrectomy Pack, Catalog No... | Bausch & Lomb Incorporated | HQE | ||
| Z-0765-2007 | Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter... | Bausch & Lomb Incorporated | HQE | ||
| Z-0625-2007 | HoMedics Thera P King size Moist/Dry Heating Pad; Model No. HP-300 (UPC 031262003645). | FKA Distributing Co., LLC | IRT | ||
| Z-0624-2007 | HoMedics Thera P Standard size Moist/Dry Heating Pad with Auto Shut-off, Model No... | FKA Distributing Co., LLC | IRT | ||
| Z-0623-2007 | HoMedics Thera-P Standard size Moist/Dry Heating Pad, Model No. HP-150 (UPC 031262003638)... | FKA Distributing Co., LLC | IRT | ||
| Z-0622-2007 | HoMedics Thera P Standard size Dry Heating Pad; Model No. HP-100 (UPC 031262003621). | FKA Distributing Co., LLC | IRT | ||
| Z-0968-2007 | Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip... | Medtronic Cardiac Surgery Technologies | FZP | ||
| Z-0699-2007 | Boston Scientific SpyGlass Camera Ref Number: 4610 UPN M00546100 | Boston Scientific Corporation | KOG | ||
| Z-0698-2007 | Boston Scientific SpyGlass Light Cable Reference Number: 4621 UPN M00546210 | Boston Scientific Corporation | EQH | ||
| Z-0697-2007 | Boston Scientific SpyGlass Ocular Reference Number: 4604 UPN M00546040 | Boston Scientific Corporation | KOG | ||
| Z-0696-2007 | Boston Scientific SpyGlass Visualization Probe Reference Number: 4603 UPN M00546030 | Boston Scientific Corporation | KOG | ||
| Z-0597-2007 | ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01... | DSM Biomedical, Inc. | MCW | ||
| Z-0668-2007 | Matrix2 Detachable Coils, vascular embolization device. Catalog Number: 497204SR, UPN... | Boston Scientific Corporation | HCG | ||
| Z-0554-2007 | Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter... | STERIS Corporation | GDC | ||
| Z-0915-2007 | GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic Imaging System (Vascular... | GE Healthcare | MQB | ||
| Z-0914-2007 | GE Healthcare Innova 3100/3100 IQ Digital Fluoroscopic Imaging system ( Cardiovascular... | GE Healthcare | MQB | ||
| Z-0913-2007 | GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and... | GE Healthcare | MQB | ||
| Z-1000-2007 | Vitatron T-Series Dual Chamber pacemaker T60 DR, model T60A1. The Vitatron C60 DR is a... | Medtronic, Inc. | NVZ | ||
| Z-0999-2007 | Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the... | Medtronic, Inc. | NVZ | ||
| Z-0661-2007 | MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer | FUJIFILM SonoSite,Inc. | IYN | ||
| Z-0768-2007 | Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions... | Abbott Medical | FRN | ||
| Z-0986-2007 | Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software | Canon Medical Systems USA, Inc. | IYN | ||
| Z-0985-2007 | Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software | Canon Medical Systems USA, Inc. | IYN | ||
| Z-0654-2007 | Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only, manufactured at... | Medtronic Sofamor Danek USA Inc | KWQ | ||
| Z-0653-2007 | Colorado 2 Spinal System, Anterior Plate, REF8639500, for export only, manufactured at... | Medtronic Sofamor Danek USA Inc | KWQ | ||
| Z-0547-2007 | One Touch Basic/Profile and One Touch Ultra-Blood Glucose Test strips- 50-count | Safety & Supplies Co. Inc. | NBW | ||
| Z-0784-2007 | GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance... | GE Healthcare | CBK | ||
| Z-0747-2007 | VITROS Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack... | Ortho-Clinical Diagnostics, Inc. | LOM | ||
| Z-0675-2007 | Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Conical Reamer... | Zimmer GmbH | LXH | ||
| Z-0714-2007 | ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625 | Amphenol Critical Medical Technologies, LLC | FRO | ||
| Z-0579-2007 | AXIOM Artis MP, Angiographic x-ray system, model number 7555365 | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0578-2007 | AXIOM Artis MP, Angiographic x-ray system, model number 5904466 | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0652-2007 | Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system. | Siemens Medical Solutions USA, Inc. | LLZ |