124 results
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14ms
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Sources: EU EUDAMED, US FDA
Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
FDA Recall
Terminated
·C.R. Bard, Inc.·Product code EZC·December 13, 2017
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.
FDA Recall
Terminated
·C.R. Bard, Inc., Urological Division·Product code EZC·June 29, 2012
Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS
FDA Recall
Terminated
·Medline Industries Inc·Product code MNL·June 15, 2018
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric). Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular).
FDA Recall
Terminated
·GE Healthcare, LLC·Product code IYN·December 28, 2018
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code LJT·December 4, 2017
Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code LJT·December 4, 2017
Maquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardiac (2) material: 701067350R02 BEQ-TOP 5208 ECC Small-Cardiac
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Adult ECC Pack
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 inch ECC Pack (2) Material :701055490R02 BEQ-TOP 15801 1/4 in ECC Pack
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
FDA Recall
Terminated
·Limacorporate S.p.A Via Nazionale 52 San Daniele Del Friuli Italy·Product code HSD·August 14, 2015
Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Sheet Cup /189028, 160170/ EDI BZO Uncut Sheet-Cup/ 189081, 160120/ EDI MET1000 Uncut Sheet-Cup/ 189082, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189123, 160130/ EDI COC Uncut Sheet-Cup/ 189124, 160160/ EDI OPI2000 Uncut Sheet-Cup/ 189166, 160163/ EDI OPI (300) Uncut Sheet-Cup/ 189191, 160110/ EDI AMP Uncut Sheet-Cup/ 189371, 160140/ EDI THC Uncut Sheet Cup/ 189372, 160123/ EDI MET(300) Uncut Sheet-Cup/ 189425, 160170/ EDI BZO Uncut Sheet-Cup/ 189426, 100163/ EDI OPI (300) Uncut Sheet-Card/ 189456, 160170/ EDI BZO Uncut Sheet-Cup/ 189565, 160180/ EDI PCP Uncut Sheet-Cup/ 189601, 160125/ EDI MET(500) Uncut Sheet-Cup/ 189748, 160130/ EDI COC Uncut Sheet-Cup/ 189786, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189844, 160180/ EDI PCP Uncut Sheet-Cup/ 189937, 160172/ EDI BZO(200) Uncut Sheet-CUP/189956 Updated 09/03/2020: EDI Affected products -Catalog Numbers/ Lot Numbers 31105-3/ PI-01081 60503s-3ZC/ PH-10132 60600/ PH-11005
FDA Recall
Terminated
·Ameditech Inc·Product code DIO·August 18, 2020
BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
FDA Recall
Terminated
·Datascope Corporation·Product code DTN·October 19, 2017
Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
FDA Recall
Terminated
·Datascope Corporation·Product code DTN·October 19, 2017
Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material: 701054295R01
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge- BEQ-TOP 32200 ECC Pack Material: 701053319R01
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019