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-0843-2012 | The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and... | Biomet Microfixation | HRS | ||
| Z-0506-2012 | Walgreens Quick Read Digital Thermometer; an electronic digital thermometer; Model... | Walgreen Co. | FLL | ||
| Z-1649-2012 | Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are... | CAPTIVA SPINE, Inc. | KWQ | ||
| Z-1648-2012 | Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are... | CAPTIVA SPINE, Inc. | KWQ | ||
| Z-0772-2012 | Dimension(R) Creatinine Flex(R) Reagent Cartridges. The CREA method is an in vitro... | Siemens Healthcare Diagnostics Inc. | CGX | ||
| Z-0585-2012 | GE Healthcare Discovery XR650, Digital Radiographic Systems. Revolution XR/d Digital... | GE Healthcare | KPR | ||
| Z-0584-2012 | GE Healthcare Definium 8000, Digital Radiographic Systems. Revolution XR/d Digital... | GE Healthcare | KPR | ||
| Z-1943-2013 | Class II | SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH... | GE Healthcare | LNH | |
| Z-0428-2012 | Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL , Product... | Abbott Medical | LGZ | ||
| Z-0427-2012 | Level 1 Normothermic I.V. Fluid Administration Sets, Product Code D-60HL , Product... | Abbott Medical | LGZ | ||
| Z-0426-2012 | HOTLlNE Disposable Administration Sets, Product Code L-80 Product Usage: Single... | Abbott Medical | LGZ | ||
| Z-0425-2012 | HOTLlNE Disposable Administration Sets, Product Code L-370 Product Usage: Single... | Abbott Medical | LGZ | ||
| Z-0424-2012 | HOTLlNE Disposable Administration Sets, Product Code L-270 Product Usage: Single... | Abbott Medical | LGZ | ||
| Z-0423-2012 | HOTLlNE Disposable Administration Sets, Product Codes L-70NI Product Usage: Single... | Abbott Medical | LGZ | ||
| Z-0422-2012 | HOTLlNE Disposable Administration Sets, Product Codes L-70 Product Usage: Single... | Abbott Medical | LGZ | ||
| Z-0205-2012 | SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110... | Cordis US Corp. | DQO | ||
| Z-0204-2012 | SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110... | Cordis US Corp. | DQO | ||
| Z-1212-2012 | Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and... | Philips North America LLC | IZI | ||
| Z-0988-2012 | Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130... | Philips North America LLC | KPS | ||
| Z-0594-2012 | Pinnacle3 Radiation Therapy Planning System, software version 9.0. Model #... | Philips North America LLC | IYE | ||
| Z-0596-2012 | 0.9% Sodium Chloride Injection, USP, pre-filled flush solution, for IV Flush only... | Abbott Medical | NGT | ||
| Z-0402-2013 | Class II | Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1... | Metrex Research | EBA | |
| Z-1276-2012 | Osteonics Shoulder Glenoid Spanner Howmedica Osteonics Corp. 325 Corporate Drive Mahwah... | Howmedica Osteonics Corp | LXH | ||
| Z-1144-2012 | Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch... | Integra LifeSciences Corporation | OYK | ||
| Z-0513-2012 | Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678)... | Siemens Healthcare Diagnostics Inc. | JIT | ||
| Z-0453-2012 | Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers... | Cepheid | NQX | ||
| Z-0486-2012 | GE Healthcare AW Server version 2.0 with release 2.0 - 4.0 A medical software system... | GE Healthcare | LLZ | ||
| Z-0978-2012 | Terumo, Sarns Sternal Saw I System, Catalog 6090. The Sarns Sternal Saw I is indicated... | Terumo Cardiovascular Systems Corporation | DWH | ||
| Z-0968-2012 | XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners. Product... | Maquet Cardiovascular LLC | MWS | ||
| Z-0967-2012 | ACROBAT Stabilizers- ACROBAT V Vacuum Off-Pump System (OM-91 OOS), ACROBAT SUV Vacuum... | Maquet Cardiovascular LLC | MWS | ||
| Z-0655-2012 | Allen C-Flex Head Positioning System non-invasive medical device used to support a... | Allen Medical Systems, Inc. | CCX | ||
| Z-0368-2012 | Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems... | Zimmer GmbH | LPH | ||
| Z-0367-2012 | Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral... | Zimmer GmbH | LPH | ||
| Z-0366-2012 | Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Primary Hip Prosthesis... | Zimmer GmbH | LPH | ||
| Z-0073-2013 | Class III | Sunquest Laboratory : intended for use by professionals working in a clinical laboratory. | CliniSys, Inc | JQP | |
| Z-1323-2012 | The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device... | Biomet Microfixation | IRQ | ||
| Z-0681-2012 | Zee Clear Vinyl Medical Examination Gloves, Powder Free, X-Large, Non-Sterile; 100 gloves... | Cypress Medical Products LLC | LYZ | ||
| Z-0680-2012 | Zee Clear Vinyl Medical Examination Gloves, Powder Free, Large, Non-Sterile; 100 gloves... | Cypress Medical Products LLC | LYZ | ||
| Z-0679-2012 | Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves... | Cypress Medical Products LLC | LYZ | ||
| Z-0350-2012 | AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear SPHERE Soft Contact Lenses... | CooperVision, Inc. | LPL | ||
| Z-0861-2012 | 5100-03-707 -- MOST Option STEM DISTRACTOR MATL: SS NONSTERILE QTY-1 Designed to... | Zimmer GmbH | JDI | ||
| Z-0006-2013 | Class II | Endoscopic retrieval device. The disposable Raptor grasping device in intended to... | United States Endoscopy Group, Inc. | FGO | |
| Z-0638-2012 | Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model... | Haag-Streit USA Inc | HJB | ||
| Z-0445-2012 | Crystalens Accommodating Posterior Chamber Intraocular Lens, AT-50AO. Crystalens... | Bausch & Lomb Incorporated | NAA | ||
| Z-0461-2012 | SPOT-Light" HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen... | Life Technologies Corporation | NYQ | ||
| Z-0693-2012 | Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial... | Philips North America LLC | JAK | ||
| Z-0520-2012 | Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. Lifescreen Apnea is... | GE Healthcare | MNR | ||
| Z-0773-2012 | Tobramycin Calibrators, REF 7F93-01; Microgenics Corporation, 46360 Fremont Blvd... | Microgenics Corporation | DLJ | ||
| Z-0489-2012 | ADVIA Centaur CA19-9 Assay Cat. Nos. 123521 (03481938) - 250 Test kit w/o... | Siemens Healthcare Diagnostics Inc. | NIG | ||
| Z-0388-2012 | Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise... | Canon Medical Informatics, Inc. | LLZ |