FDA Device · 2019
FDA Device recalls in 2019
RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.
- Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler
FDA Device · Class II · 2019-06-05 · Abbott And Kg - Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 32200 ECC PACK - Material: 701053319
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material:701050859R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material:-709000266R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge- BEQ-T 5211 ECC Large Children's Hospital Material: 701064560R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU Material: 701067372
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" Material: 701065504
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
FDA Device · Class I · 2019-06-05 · Terumo Medical - Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID Material: 701055601
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - McKesson Cardiology Hemo
FDA Device · Class II · 2019-06-05 · Change Healthcare Israel - Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 15705 Material: 701051122
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC Material: 709000516
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC Material:701054438
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA Material:701066551
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
FDA Device · Class II · 2019-06-05 · Abbott Vascular - Maquet Getinge- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm (2) Material: 701063255R02 BEQ-TOP 25003 3/8 3/8 up to 7 lpm
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
FDA Device · Class II · 2019-06-05 · Teleflex Medical - Maquet Getinge-BEQ-T 5915 TCH 3/8 Inch Change Kit Material: 709000280
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 46500 PRIME PACK Material:701065823
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 47800 STRINGFELLOW PED Material:701066583
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For Material: 701064867R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 Material: 709000430
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8 - Material: 709000078R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BO-TOP 30300 Material:701052623
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 4963 CARDIOPLEGIA PACK Material: 701067203
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge- BEQ-T 53500 Evanston Rotaflow Pack Material:709000215R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to prov…
FDA Device · Class II · 2019-06-05 · Pf Consumer Healthcare 1 - Maquet Getinge-BEQ-TOP 17207 3/8" ECC Pack Material:701049346R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack Material:701050177R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge- BEQ-TOP 46700 ADULT ECC PACK Material:701065833R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack Material: 701067069R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge- BEQ-TOP 27700 Quadrox iD Pack Material: 701054389R02
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BO-TOP 13901 RAPID RESPONSE Material:701054874
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack Material: 709000370
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 ¿ inch ECC Pack (2) Material :701055490R02 BEQ-TOP 15801 1/4 in ECC Pack
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material: 701054295R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 4901 Material: 701050839
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 8208#3/8 inch ECC Pack Material: 701068798
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge- BEQ-TOP 24100 Small Patient ECC Pack Material:701050175R02
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI Material: 701065512
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P Material:701066366
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 4932 Mercy Adaptation Pk Pediatric Material:709000520
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (2) Material: 701067370R02 BO-TOP 38803 OPEN HEART PACK W (3) Mat…
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY Material: 701064590
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 701054874R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8 Material:701049440R02
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK Material:701064804
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack Material: 701065620
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular
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