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-1580-2008 | Triathlon TS Femoral Trial; Size 5 Left Non-Sterile Catalog Number: 5512-T-501 Howmedica... | Howmedica Osteonics Corp | LXH | ||
| Z-1579-2008 | Triathlon TS Femoral Trial; Size 4 Right Non-Sterile Catalog Number... | Howmedica Osteonics Corp | LXH | ||
| Z-1578-2008 | Triathlon TS Femoral Trial; Size 4 Left Non-Sterile Catalog Number: 5512-T-401 Howmedica... | Howmedica Osteonics Corp | LXH | ||
| Z-1577-2008 | Triathlon TS Femoral Trial Size 3 Right Non-Sterile Catalog Number... | Howmedica Osteonics Corp | LXH | ||
| Z-1576-2008 | Triathlon TS Femoral Trial; Size 3 Left Non-Sterile Catalog Number: 5512-T-301 Howmedica... | Howmedica Osteonics Corp | LXH | ||
| Z-1575-2008 | Triathlon TS Femoral Trial; Size 2 Right Non-Sterile Catalog Number... | Howmedica Osteonics Corp | LXH | ||
| Z-1574-2008 | Triathlon TS Femoral Trial; Size 2 Left Non-Sterile Catalog Number 5512-T-201 Howmedica... | Howmedica Osteonics Corp | LXH | ||
| Z-1573-2008 | Triathlon TS Femoral Trial; Size 1 Right Non-Sterile Catalog number... | Howmedica Osteonics Corp | LXH | ||
| Z-1572-2008 | Triathlon TS Femoral Trial; Size 1 Left Non-Sterile Catalog number 5512-T-101 Howmedica... | Howmedica Osteonics Corp | LXH | ||
| Z-1711-2008 | Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built... | CareFusion 303, Inc | FRN | ||
| Z-1710-2008 | U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules... | CareFusion 303, Inc | FRN | ||
| Z-0068-2012 | STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One... | Kapp Surgical GmbH | KGT | ||
| Z-1474-2008 | Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator... | MEDLINE INDUSTRIES, LP - Northfield | CAW | ||
| Z-1473-2008 | Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator... | MEDLINE INDUSTRIES, LP - Northfield | CAW | ||
| Z-1541-2008 | IntelliVue Clinical Information Portfolio Critical Care Release D, Version... | Philips North America LLC | DXJ | ||
| Z-1540-2008 | CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246. This... | Philips North America LLC | DXJ | ||
| Z-1380-2008 | Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure... | Abbott Medical | BYE | ||
| Z-1379-2008 | Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory... | Abbott Medical | BYE | ||
| Z-1717-2009 | M-19 (Iridium 192): Source Production and Equipment Company, St. Rose... | Source Production and Equipment Co., Inc. | KXK | ||
| Z-2177-2008 | Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic... | Cook Vandergrift, Inc. | MQH | ||
| Z-2176-2008 | Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The... | Cook Vandergrift, Inc. | MQH | ||
| Z-1912-2008 | Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS)... | Medtronic Neuromodulation | LGW | ||
| Z-1639-2008 | INTELECT TRANSPORT ULTRASOUND, electromechanical therapeutic ultrasound device, Model No... | Chattanooga Corp Inc | IMI | ||
| Z-1638-2008 | VECTRA GENISYS, electromechanical therapeutic ultrasound and powered muscle stimulation... | Chattanooga Corp Inc | IMG | ||
| Z-1637-2008 | INTELECT LEGEND XT, electromechanical therapeutic ultrasound and powered muscle... | Chattanooga Corp Inc | IMG | ||
| Z-1636-2008 | VECTRA GENISYS, electromechanical therapeutic ultrasound device, Model No. 2759... | Chattanooga Corp Inc | IMI | ||
| Z-1546-2008 | Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field... | Hologic, Inc. | MUE | ||
| Z-1393-2008 | Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 100 units/mL-1 mL... | Baxter Healthcare Corporation | NZW | ||
| Z-1392-2008 | Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 10 units/mL-1 mL... | Baxter Healthcare Corporation | NZW | ||
| Z-1391-2008 | Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-30 mL vial, 25 pack... | Baxter Healthcare Corporation | NZW | ||
| Z-1390-2008 | Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-10 mL vial, 25 pack... | Baxter Healthcare Corporation | NZW | ||
| Z-1389-2008 | Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack... | Baxter Healthcare Corporation | NZW | ||
| Z-1388-2008 | Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-2 mL vial, 25 pack, NDC... | Baxter Healthcare Corporation | NZW | ||
| Z-1387-2008 | Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 units/mL-30 mL vial; 25 pack, NDC... | Baxter Healthcare Corporation | NZW | ||
| Z-1386-2008 | Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-10 mL vial; 25 pack, NDC... | Baxter Healthcare Corporation | NZW | ||
| Z-1385-2008 | Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 u/mL-2 mL vial, 25 pack... | Baxter Healthcare Corporation | NZW | ||
| Z-1384-2008 | Baxter HEP LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-1mL vial, 25 Pack, NDC... | Baxter Healthcare Corporation | NZW | ||
| Z-1614-2008 | Fiducial Markers (0.9 x 3 mm) Soft tissue gold markers, Medical charged-particle... | Medtec LLC | IYE | ||
| Z-1613-2008 | Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation... | Medtec LLC | IYE | ||
| Z-1619-2008 | BCI 3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical... | Abbott Medical | DQA | ||
| Z-1605-2008 | Deltec Micro 3100 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc... | Abbott Medical | FRN | ||
| Z-1604-2008 | Deltec 3000 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265... | Abbott Medical | FRN | ||
| Z-1446-2008 | QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for fixation... | Integra LifeSciences Corporation | HWC | ||
| Z-1445-2008 | QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation... | Integra LifeSciences Corporation | HWC | ||
| Z-1570-2008 | Architect Total T4 MasterCheck; a single (specified) analyte control (assayed and... | Abbott Medical | JJX | ||
| Z-1569-2008 | Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and... | Abbott Medical | JJX | ||
| Z-1567-2008 | FASTPAK batteries labeled Manufactured for Medtronic Physio-Control 11811 Willows Rd... | Physio Control, Inc. | MKJ | ||
| Z-1656-2008 | LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be... | Physio Control, Inc. | MKJ | ||
| Z-2266-2012 | Class II | Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or... | Canon Medical Systems USA, Inc. | JAK | |
| Z-1894-2008 | Edwards Lifesciences LLC, Fem-Flex II Duraflo Treated Femoral Venous Catheter, 8 Fr. x... | Edwards Lifesciences LLC | DWF |