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-1519-06 | Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and... | Biogenex Laboratories, Inc. | NJT | ||
| Z-1508-06 | Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS... | ConMed Corporation | GEI | ||
| Z-1507-06 | Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS, Conmed Corporation | ConMed Corporation | GEI | ||
| Z-1533-2010 | Leksell Gamma Knife C | Elekta Limited | IWB | ||
| Z-0219-2007 | CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402... | AGFA Healthcare Corp. | MBQ | ||
| Z-0082-2007 | TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The... | Tosoh Bioscience Inc | JIS | ||
| Z-0158-2007 | Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank | Maquet Cardiovascular Us Sales, LLC | DTQ | ||
| Z-0423-2007 | OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part... | Teknimed SAS | MQV | ||
| Z-0339-2007 | Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd... | Abbott Medical | JOH | ||
| Z-0194-2007 | Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy... | Varian Medical Systems, Inc. | IYE | ||
| Z-0196-2007 | Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02 | Exactech, Inc. | JWH | ||
| Z-0444-2007 | Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA... | Medtronic, Inc. | MNT | ||
| Z-1541-06 | Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04... | Boston Scientific Corporation | DQX | ||
| Z-1540-06 | Boston Scientific PT2 Moderate Support Guide Wire 185cm J-Tip, Catalog Number 38931-03... | Boston Scientific Corporation | DQX | ||
| Z-1539-06 | Boston Scientific PT2 Light Support Guide Wire 300cm J-Tip, Catalog Number 38931-02... | Boston Scientific Corporation | DQX | ||
| Z-1538-06 | Boston Scientific PT2 Light Support Guide Wire 185cm J-Tip, Catalog Number 38931-01... | Boston Scientific Corporation | DQX | ||
| Z-0478-2007 | Minstrel Patient Lift with SR weighing scale; a non-AC-powered patient lift; Arjo, Inc... | Arjo, Inc. | FNG | ||
| Z-1502-06 | LIFEPAK 20 external defibrillator/monitor | Physio Control, Inc. | LDD | ||
| Z-0420-2007 | CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP Analysis Software Kit V2.1... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0419-2007 | Cytomics FC 500 MPL with MXP software, Versions 2.0 & 2.1: Part #731419 KIT; FOC MXP 2.0... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0418-2007 | Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0182-2007 | MIDAS TOUCH Electrosurgical/102 mm (4 inch) Blade Electrodes, Disposable, Sterile Single... | Olsen Medical | JOS | ||
| Z-0073-2007 | HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique... | Sebia, Inc. | JBD | ||
| Z-0011-2007 | Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102... | Smith & Nephew, Inc. | LXH | ||
| Z-0010-2007 | Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482... | Smith & Nephew, Inc. | LXH | ||
| Z-0009-2007 | Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815... | Smith & Nephew, Inc. | LXH | ||
| Z-1521-06 | OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966 | Sybron Dental Specialties, Inc. | KLE | ||
| Z-0028-2007 | Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating... | Lumenis Ltd | GEX | ||
| Z-1513-06 | Stryker Power-PRO Powered Ambulance Cot, Model 6500. | Stryker Medical | FPO | ||
| Z-0380-2007 | NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used... | Medtronic, Inc. | GWQ | ||
| Z-0004-2007 | Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No... | Abbott Medical | DSQ | ||
| Z-0449-2007 | Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. | JAS Diagnostics/Drew Scientific | GKZ | ||
| Z-0448-2007 | Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. | JAS Diagnostics/Drew Scientific | GKZ | ||
| Z-0162-2007 | Allura Xper FD 10 x-ray, angiographic system | Philips North America LLC | IZI | ||
| Z-0161-2007 | Allura Xper FD 10/10 x-ray, angiographic system | Philips North America LLC | IZI | ||
| Z-0038-2007 | DeVilbiss iFill Personal Oxygen Station model number 535D. | Sunrise Medical, Inc. | CAW | ||
| Z-0218-2007 | Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of... | Nihon Kohden America Inc | GWF | ||
| Z-0170-2007 | 5 Qt. Wallmount Sharps Container, Model 150, Regular Size; colors 202 Beige, 030 Red, 040... | Bemis Health Care | MMK | ||
| Z-0078-2007 | HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates... | Hardy Diagnostics | GMZ | ||
| Z-1503-06 | Hill-Rom Affinity Three Birthing Bed, Model P3700. | Hill-Rom Inc. | KNC | ||
| Z-1520-2008 | GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography... | GE Healthcare | MQB | ||
| Z-1519-2008 | GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular imaging... | GE Healthcare | MQB | ||
| Z-1518-2008 | GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and... | GE Healthcare | MQB | ||
| Z-0499-2007 | Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at +... | EMD Millipore Corporation | J | ||
| Z-0498-2007 | Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6... | EMD Millipore Corporation | J | ||
| Z-0147-2007 | First Aid Kit, Nexcare brand, all purpose first aid kit containing acetaminophen and a... | Acme United Corp. | LRR | ||
| Z-0146-2007 | First Aid kits, Pharmacist''s Choice, containing acetaminophen and a variety of first aid... | Acme United Corp. | LRR | ||
| Z-0145-2007 | First Aid kits, First Aid Only brand, containing various products to include... | Acme United Corp. | LRR | ||
| Z-1505-06 | BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog #... | Becton Dickinson & Co | LHJ | ||
| Z-0243-2007 | bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790 | bioMerieux, Inc. | MDB |