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-2928-2011 | remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. The firm name... | Remel Inc | JSO | ||
| Z-2410-2011 | SpeediCath , SpeediCath with Accessories Coloplast Corp -MN, Sterile R, Manufacturer... | MEDLINE INDUSTRIES, LP - Northfield | GBM | ||
| Z-2409-2011 | SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer... | MEDLINE INDUSTRIES, LP - Northfield | EZD | ||
| Z-2734-2011 | Foundation Knee System Instrumentation, Tibial Broach Assembly. Used in conjunction with... | Encore Medical, LP | HTQ | ||
| Z-2294-2011 | Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11 The... | ZOLL Medical Corporation | MKJ | ||
| Z-2684-2011 | Terumo Cardiovascular Systems, CDI 100 Hematocrit/Oxygen saturation monitoring system... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-2683-2011 | Terumo Cardiovascular Systems, CDI 101 Hematocrit/Oxygen saturation monitoring system... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-2682-2011 | Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with venous... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-2681-2011 | Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-2680-2011 | Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-2679-2011 | Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-2678-2011 | Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with Arterial... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-2413-2011 | ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for... | Abbott Medical | LOL | ||
| Z-2707-2011 | MaxPlus bifuse extension set (minibore) needleless connectors, Model Number... | CareFusion 303, Inc | FPA | ||
| Z-2608-2011 | BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar... | Becton Dickinson & Co | JTZ | ||
| Z-2629-2011 | Servo-s Ventilator Systems; Article number 66 40 440. Intended for treatment and... | Maquet Cardiovascular Us Sales, LLC | CBK | ||
| Z-2628-2011 | Servo-i Ventilator Systems; Article number 64 87 800 Intended for treatment and... | Maquet Cardiovascular Us Sales, LLC | CBK | ||
| Z-2590-2011 | ENDO-FUSE(TM) FUSION ROD, 7 mm X 70 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF... | Wright Medical Technology Inc | HWC | ||
| Z-2589-2011 | ENDO-FUSE(TM) FUSION ROD 7 mm X 50 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF... | Wright Medical Technology Inc | HWC | ||
| Z-2199-2011 | The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator... | Fresenius Kabi AB | LKN | ||
| Z-2242-2011 | Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient... | Salter Labs | CCK | ||
| Z-2237-2011 | Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube... | Salter Labs | CCK | ||
| Z-2391-2011 | Churchill Medical Systems AMS-9189CP-1 (Dressing Change Kit) -Medium Glove. Churchill... | Vygon U.S.A. | LKB | ||
| Z-2390-2011 | Churchill Medical Systems AMS-8431CP (PICC insertion Tray). The device intended use is a... | Vygon U.S.A. | LKB | ||
| Z-2389-2011 | Churchill Medical Systems AMS-8316CP-1 (Central Line Dressing Kit). The device intended... | Vygon U.S.A. | LKB | ||
| Z-2388-2011 | Churchill Medical Systems AMS-7080CP (Dressing Change Kit). The device intended use is a... | Vygon U.S.A. | LKB | ||
| Z-2292-2011 | WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight Model... | WAVELIGHT GmbH | HNO | ||
| Z-2765-2011 | Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a... | Philips North America LLC | JAA | ||
| Z-2739-2011 | Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd... | Encore Medical, LP | KWS | ||
| Z-1038-2012 | Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use... | Alto Development Corp | LDF | ||
| Z-2659-2011 | Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). The device... | Pro Trainers' Choice Company | ILO | ||
| Z-2467-2011 | Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace... | FUJIFILM Healthcare Americas Corporation | IYN | ||
| Z-3158-2011 | Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-32-39, REF G32184, 20 Fr... | Cook Incorporated | MIH | ||
| Z-3157-2011 | Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-30-39, REF G32183, 20 Fr... | Cook Incorporated | MIH | ||
| Z-3156-2011 | Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-22-29, REF G32179, 18 Fr... | Cook Incorporated | MIH | ||
| Z-3155-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-24-90-ZT, REF G48479... | Cook Incorporated | MIH | ||
| Z-3154-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-24-73-ZT, REF G48478... | Cook Incorporated | MIH | ||
| Z-3153-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48477... | Cook Incorporated | MIH | ||
| Z-3152-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48476... | Cook Incorporated | MIH | ||
| Z-3151-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-22-73-ZT, REF G48474... | Cook Incorporated | MIH | ||
| Z-3150-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48473... | Cook Incorporated | MIH | ||
| Z-3149-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-90-ZT, REF G48471... | Cook Incorporated | MIH | ||
| Z-3148-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48470... | Cook Incorporated | MIH | ||
| Z-3147-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48469... | Cook Incorporated | MIH | ||
| Z-3146-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-73-ZT, REF G48466... | Cook Incorporated | MIH | ||
| Z-3145-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-56-ZT, REF G48465... | Cook Incorporated | MIH | ||
| Z-3144-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-90-ZT, REF G48463... | Cook Incorporated | MIH | ||
| Z-3143-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-73-ZT, REF G48462... | Cook Incorporated | MIH | ||
| Z-3142-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-56-ZT, REF G48461... | Cook Incorporated | MIH | ||
| Z-3141-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-14-56-ZT, REF G48455... | Cook Incorporated | MIH |