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-0100-2013 | Class II | Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 22g... | Westmed Inc | CBT | |
| Z-0099-2013 | Class II | Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, with Eclipse, 25 g... | Westmed Inc | CBT | |
| Z-0098-2013 | Class II | Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, 25 g x 5/8" A... | Westmed Inc | CBT | |
| Z-0097-2013 | Class II | Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, with Eclipse... | Westmed Inc | CBT | |
| Z-0096-2013 | Class II | Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g... | Westmed Inc | CBT | |
| Z-0905-2011 | BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose... | Philips North America LLC | IZO | ||
| Z-2238-2026 | Class I | Automated Impella Controller (AIC) with the below product descriptions and corresponding... | Abiomed, Inc. | OZD | |
| Z-1721-2011 | KING SYSTEMS, A Consort Medical Company, KLTSD415, Quantity: 5 PER CASE, KING KLTSD, KIT... | King Systems Corporation. | CAE | ||
| Z-1720-2011 | KING SYSTEMS, A Consort Medical Company, KLTSD414, Quantity: 5 PER CASE, KING LTSD, KIT... | King Systems Corporation. | CAE | ||
| Z-1719-2011 | KING SYSTEMS, A Consort Medical Company, KLTSD413, Quantity: 5 PER CASE, KING LTSD, KIT... | King Systems Corporation. | CAE | ||
| Z-1718-2011 | KING SYSTEMS, A Consort Medical Company, KLTD215, Quantity: 5 PER CASE, KING LT-D, KIT... | King Systems Corporation. | CAE | ||
| Z-1717-2011 | KING SYSTEMS, A Consort Medical Company, KLTD214, Quantity: 5 PER CASE, KING LT-D, KIT... | King Systems Corporation. | CAE | ||
| Z-1716-2011 | KING SYSTEMS, A Consort Medical Company, KLTD213, Quantity: 5 PER CASE, KING LT-D, KIT... | King Systems Corporation. | CAE | ||
| Z-1715-2011 | KING SYSTEMS, A Consort Medical Company, KLTD2125, Quantity: 5 PER CASE, KING LT-D, KIT... | King Systems Corporation. | CAE | ||
| Z-1714-2011 | KING SYSTEMS, A Consort Medical Company, KLTD212, Quantity: 5 PER CASE, KING LT-D, KIT... | King Systems Corporation. | CAE | ||
| Z-1713-2011 | CRQ425, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company... | King Systems Corporation. | CAE | ||
| Z-1712-2011 | CRQ424, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company... | King Systems Corporation. | CAE | ||
| Z-1711-2011 | CRQ423, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company... | King Systems Corporation. | CAE | ||
| Z-1710-2011 | KING LTS-D, SIZE 5, QUANTITY 5 EACH, Distributed by North American Rescue, Greer, South... | King Systems Corporation. | CAE | ||
| Z-1709-2011 | KING LTS-D, SIZE 4, QUANTITY 5 EACH, Distributed by North American Rescue, Greer, South... | King Systems Corporation. | CAE | ||
| Z-1708-2011 | KING LTS-D, SIZE 3, QUANTITY 5 EACH, Distributed by North American Rescue, Greer, South... | King Systems Corporation. | CAE | ||
| Z-1707-2011 | KING LTD, SIZE 5, QUANTITY 1 EACH, Distributed by North American Rescue, Greer, South... | King Systems Corporation. | CAE | ||
| Z-1706-2011 | KING LTD, SIZE 4, QUANTITY 1 EACH, Distributed by North American Rescue, Greer, South... | King Systems Corporation. | CAE | ||
| Z-1705-2011 | KING LT-D, SIZE 3, QUANTITY 1 EACH, Distributed by North American Rescue, Greer, South... | King Systems Corporation. | CAE | ||
| Z-1421-2011 | AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS System, X-Ray, Fluoroscopic... | Siemens Medical Solutions USA, Inc. | MQB | ||
| Z-1471-2011 | Dressing Change Tray, DT5880A, Sterile, Centurion Medical Products Corp., Williamston... | Centurion Medical Products, LP | MCY | ||
| Z-1470-2011 | Dressing Change Kit, DT15215, Sterile, Centurion Medical Products Corp., Williamston... | Centurion Medical Products, LP | MCY | ||
| Z-1469-2011 | IN-PATIENT Port Access Dressing Tray, DT14880, Sterile, Centurion Medical Products... | Centurion Medical Products, LP | MCY | ||
| Z-1468-2011 | OUT-PATIENT Port Access Dressing Tray, DT14875, Sterile, Centurion Medical Products... | Centurion Medical Products, LP | MCY | ||
| Z-1467-2011 | PICC/Central Line Dressing Change Tray, DT14675, Sterile, Centurion Medical Products... | Centurion Medical Products, LP | MCY | ||
| Z-1466-2011 | Central Line Dressing Change Tray, DT13850, Sterile, Centurion Medical Products Corp... | Centurion Medical Products, LP | MCY | ||
| Z-1465-2011 | Dressing Change Tray , DT13650, Sterile, Centurion Medical Products Corp., Williamston... | Centurion Medical Products, LP | MCY | ||
| Z-1464-2011 | Dressing Change Tray, DT12770, Sterile, Centurion Medical Products Corp., Williamston... | Centurion Medical Products, LP | MCY | ||
| Z-1463-2011 | Dressing Change Tray for Hickman & Dialysis Catheters, DT12110, Sterile, Centurion... | Centurion Medical Products, LP | MCY | ||
| Z-1462-2011 | Dressing Change Tray for CVC & PICC Lines, DT12105, Sterile, Centurion Medical Products... | Centurion Medical Products, LP | MCY | ||
| Z-1461-2011 | Central Line Dressing Change Tray, DT10020, Sterile, Centurion Medical Products Corp... | Centurion Medical Products, LP | MCY | ||
| Z-1460-2011 | Universal Insertion Tray Bundle, CV13530, Sterile, Centurion Medical Products Corp... | Centurion Medical Products, LP | LRS | ||
| Z-1724-2011 | W Vital Health Pulsating Clean Rechargeable Toothbrush; Distributed by: Walgreen Co., 200... | Brushpoint Innovations, Inc. | JEQ | ||
| Z-1062-2011 | Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump The SynchroMed... | Medtronic Neuromodulation | LKK | ||
| Z-1061-2011 | Medtronic SynchroMed implantable drug pump Refill Kits (Model No: 8551, 8555, 8561... | Medtronic Neuromodulation | LKK | ||
| Z-1060-2011 | Medtronic SynchroMed II (Model No: 8637) implantable drug pump The SynchroMed II... | Medtronic Neuromodulation | LKK | ||
| Z-2598-2011 | Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above To... | Elekta Limited | MUJ | ||
| Z-2561-2011 | Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The... | Elekta Limited | MUJ | ||
| Z-1033-2011 | Smiths Medical, CADD-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder... | Abbott Medical | MEA | ||
| Z-2405-2011 | Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized, Remington... | Remington Medical | EXF | ||
| Z-2112-2011 | ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686... | Radiometer America, Inc | CEM | ||
| Z-1643-2011 | AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc... | Depuy Orthopaedics Inc. | LXH | ||
| Z-1400-2011 | Integra Radionics HRAIM Intubation Head Ring Assembly Ref: HRAIM Head Rings serve as the... | Integra LifeSciences Corporation | HAW | ||
| Z-1728-2011 | Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide... | Qiagen | JJQ | ||
| Z-1395-2011 | SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 The SP Brand Strep A... | Alere San Diego, Inc. | GTY |
