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-1323-2019 | Class II | SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological... | Philips North America LLC | MHX | |
| Z-1322-2019 | Class II | SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the... | Philips North America LLC | MHX | |
| Z-1321-2019 | Class II | SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological... | Philips North America LLC | MHX | |
| Z-1320-2019 | Class II | SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological... | Philips North America LLC | MHX | |
| Z-1319-2019 | Class II | SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological... | Philips North America LLC | MHX | |
| Z-1318-2019 | Class II | SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological... | Philips North America LLC | MHX | |
| Z-1317-2019 | Class II | SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of... | Philips North America LLC | MHX | |
| Z-1680-2019 | Class II | Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1679-2019 | Class II | Maquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1678-2019 | Class II | Maquet Getinge-BEQ-T 52301 Sash & Accessory Pack Material:-709000266R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1677-2019 | Class II | Maquet Getinge- BEQ-T 53500 Evanston Rotaflow Pack Material:709000215R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1676-2019 | Class II | Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1675-2019 | Class II | Maquet Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8 - Material: 709000078R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1674-2019 | Class II | Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal Material: 709000069R02 | Maquet Cardiovascular LLC | DWF | |
| Z-1673-2019 | Class II | Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1672-2019 | Class II | Maquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1671-2019 | Class II | Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1670-2019 | Class II | Maquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1669-2019 | Class II | Maquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (2) Material... | Maquet Cardiovascular LLC | DWF | |
| Z-1668-2019 | Class II | Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02 | Maquet Cardiovascular LLC | DWF | |
| Z-1667-2019 | Class II | Maquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardiac (2)... | Maquet Cardiovascular LLC | DWF | |
| Z-1666-2019 | Class II | Maquet Getinge- BEQ-TOP 39202 NICU ECC PACK Material: 701067313R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1665-2019 | Class II | Maquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack Material: 701067069R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1664-2019 | Class II | Maquet Getinge- BEQ-TOP 46700 ADULT ECC PACK Material:701065833R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1663-2019 | Class II | Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material... | Maquet Cardiovascular LLC | DWF | |
| Z-1662-2019 | Class II | Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1661-2019 | Class II | Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For Material: 701064867R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1660-2019 | Class II | Maquet Getinge- BEQ-T 5211 ECC Large Children's Hospital Material: 701064560R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1659-2019 | Class II | Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1658-2019 | Class II | Maquet Getinge- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm (2)... | Maquet Cardiovascular LLC | DWF | |
| Z-1657-2019 | Class II | Maquet Getinge- BEQ-T 39700 ECC Pack Material:701062473R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1656-2019 | Class II | Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1655-2019 | Class II | Maquet Getinge BEQ-TOP 38300 ADULT CPS QID Material:701055862R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1654-2019 | Class II | Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1653-2019 | Class II | Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 inch ECC Pack (2) Material... | Maquet Cardiovascular LLC | DWF | |
| Z-1652-2019 | Class II | Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin Material: 701055388R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1651-2019 | Class II | Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 701054874R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1650-2019 | Class II | Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1649-2019 | Class II | Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack Material:701054438R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1648-2019 | Class II | Maquet Getinge- BEQ-TOP 27700 Quadrox iD Pack Material: 701054389R02 | Maquet Cardiovascular LLC | DWF | |
| Z-1647-2019 | Class II | Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material: 701054295R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1646-2019 | Class II | Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2)... | Maquet Cardiovascular LLC | DWF | |
| Z-1645-2019 | Class II | Maquet Getinge-BEQ-TOP 250011/4 1/4 Less than 20 kg up Material: 701053906R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1644-2019 | Class II | Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1643-2019 | Class II | Maquet Getinge- BEQ-TOP 32200 ECC Pack Material: 701053319R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1642-2019 | Class II | Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1641-2019 | Class II | Maquet Getinge-BEQ-TOP 28601 NEONATE ECC QPiD Material: 701051935R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1640-2019 | Class II | Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1639-2019 | Class II | Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material:701050859R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1638-2019 | Class II | Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01 | Maquet Cardiovascular LLC | DWF |