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-1689-2014 | Class II | Bard Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1688-2014 | Class II | Bard Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1687-2014 | Class II | BardVentralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1686-2014 | Class II | Bard Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1685-2014 | Class II | Bard Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1602-2014 | Class II | UPGRD PRGM 9734638 ADD AxiEM NAVIGATION | Medtronic Navigation, Inc | HAW | |
| Z-1601-2014 | Class II | Tumor Resection Kit 9733608 Skull Mount | Medtronic Navigation, Inc | HAW | |
| Z-1600-2014 | Class II | Tumor Resection Kit 9733607 Non-Invasive | Medtronic Navigation, Inc | HAW | |
| Z-1599-2014 | Class II | TUMOR RES. PACK 9733553 AxiEM S.M. | Medtronic Navigation, Inc | HAW | |
| Z-1598-2014 | Class II | Traj Guide Kit, 9733066, Biopsy, Int | Medtronic Navigation, Inc | HAW | |
| Z-1597-2014 | Class II | Traj Guide Kit, 9733065, Biopsy, Ext | Medtronic Navigation, Inc | HAW | |
| Z-1596-2014 | Class II | Spheres 8801075 5/Tray 12Pk | Medtronic Navigation, Inc | HAW | |
| Z-1595-2014 | Class II | Spheres 8801071 1/Tray 12Pk | Medtronic Navigation, Inc | HAW | |
| Z-1594-2014 | Class II | Shunt Kit 9733605 Non-Invasive | Medtronic Navigation, Inc | HAW | |
| Z-1593-2014 | Class II | Pin, 9733236, 150Mm, Sterile, Perc Ref | Medtronic Navigation, Inc | HAW | |
| Z-1592-2014 | Class II | Pin, 9733235, 100Mm, Sterile, Perc Ref | Medtronic Navigation, Inc | HAW | |
| Z-1591-2014 | Class II | Patient Tracker 9733534Xom ENT 1Pk | Medtronic Navigation, Inc | HAW | |
| Z-1590-2014 | Class II | Pak 9733497 Nav Nim-Spine Pedicle Acc Kt | Medtronic Navigation, Inc | HAW | |
| Z-1589-2014 | Class II | Pack 9731975 Tumor Resection Axiem Cr | Medtronic Navigation, Inc | HAW | |
| Z-1588-2014 | Class II | Mouse 9732721 Sterile O-Arm 10Pk | Medtronic Navigation, Inc | GXY | |
| Z-1587-2014 | Class II | Kit, 9731427, Thoracic Tactile Probes | Medtronic Navigation, Inc | HAW | |
| Z-1586-2014 | Class II | Instrument Tracker 9733533Xom ENT 1Pk | Medtronic Navigation, Inc | HAW | |
| Z-1585-2014 | Class II | Inst 9731132 Kit Cr Ref Frame Driver 5Pk | Medtronic Navigation, Inc | HAW | |
| Z-1584-2014 | Class II | ENT PRGM 9734636 ADD FUSION NAV AxiEM | Medtronic Navigation, Inc | HAW | |
| Z-1583-2014 | Class II | Drape 9732722 Tube Sterile O-Arm 20Pk | Medtronic Navigation, Inc | GXY | |
| Z-1582-2014 | Class II | Disp 9730951 Strl Sphere, 5Pk Insert | Medtronic Navigation, Inc | HAW | |
| Z-1581-2014 | Class II | Disp 9730950 Strl Sphere, 1 Pk Insert | Medtronic Navigation, Inc | HAW | |
| Z-1580-2014 | Class II | BIT 9733516 2.9mm DRILL STERILE | Medtronic Navigation, Inc | HAW | |
| Z-1579-2014 | Class II | Biopsy Needle Kit, 9733068, Passive | Medtronic Navigation, Inc | HAW | |
| Z-1578-2014 | Class II | Bag 9732315 Mouse Sterile 15 Pk | Medtronic Navigation, Inc | HAW | |
| Z-1684-2014 | Class II | Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1683-2014 | Class II | Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1682-2014 | Class II | Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1563-2014 | Class II | Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage... | Evoqua Water Technologies LLC | FIP | |
| Z-2043-2014 | Class II | Symbia E camera system. Emission Computed Tomography System used to detect or image the... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2042-2014 | Class II | e.cam camera system. Emission Computed Tomography System used to detect or image the... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-1724-2014 | Class II | Synergy XVI Intended for radiation therapy treatment. | Elekta Limited | IYE | |
| Z-1651-2014 | Class II | Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device... | Kulzer GmbH | LBH | |
| Z-1668-2014 | Class II | ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-1667-2014 | Class II | ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-1708-2014 | Class II | Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size... | C P Medical Inc. | NEW | |
| Z-1576-2014 | Class II | Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is... | William C. Domb, D.M.D., A Professional Corporation | EIA | |
| Z-1533-2014 | Class II | GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped... | GE Healthcare | LNH | |
| Z-1567-2014 | Class I | Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay... | CareFusion 303, Inc | FRN | |
| Z-2272-2016 | Class II | UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0151-2016 | Class I | HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology... | Hamilton Medical AG | CBK | |
| Z-1941-2014 | Class II | illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10... | Meridian Bioscience Inc | OMN | |
| Z-1615-2014 | Class II | ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic... | Zimmer GmbH | KWI | |
| Z-1781-2014 | Class II | Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate... | Synthes GmbH | HTZ | |
| Z-1650-2014 | Class II | SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator... | Abbott Medical | DWJ |