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17ms
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Sources: EU EUDAMED, US FDA
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Image Consultant (IC) Software
FDA Recall
Terminated
·R.O. Gulden & Co., Inc.·Product code NFF·February 5, 2010
BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI 2HH-1FM, 138906-01; MINI 3HH-1FG, 169-110; MINI 3HH-1FG, 139091-01; MINI 3HH-1HM, 169-111; MINI 4HH, 138910-01; MINI 4HH, 169-112; MINI 4HM, 169-113; MINI 4HM, 138915-01; TWR MN 10HH-1FH-1FM, 169-23; TWR MN 10HH-2FH, 169-24; TWR MN 10HH-2FH, 138955-01; TWR MN 10HH-2FM, 169-25; TWR MN 10HH-2FM, 138924-01; TWR MN 12HH-1FF, 169-26; TWR MN 12HH-1FF, 138960-01; TWR MN 12HH-1FH, 169-27; TWR MN 12HH-1FH, 138961-01; TWR MN 12HH-1FM, 169-28; TWR MN 12HH-1FM, 138926-01; TWR MN 14HH, 138927-01; TWR MN 14HH, 169-29; TWR MN 1HH-1HM-2FM-4FF, 169-30; TWR MN 2FH-2HM-4FM, 169-31; TWR MN 2HH-10HM-1FM, 169-32; TWR MN 2HH-1FH-5FM, 169-33; TWR MN 2HH-2FH-4FM, 169-34; TWR MN 2HH-4FH-2FM, 169-139; TWR MN 2HH-4HM-4FM, 139125-01; TWR MN 2HH-6FM, 169-38; TWR MN 2HH-6FM, 138919-01; TWR MN 2HH-6HM-3FM, 169-39; TWR MN 2HH-8HM-2FM, 169-40; TWR MN 2HM-6FM, 169-41; TWR MN 3FH-4FM, 169-42; TWR MN 3FH-4FM, 138933-01; TWR MN 3FH-8HH MEDPASS, 169-140; TWR MN 3HH-7HM-2FM, 169-43; TWR MN 4HH-10HM, 169-44; TWR MN 4HH-10HM, 138959-01; TWR MN 4HH-1FH-2HM-3FM, 169-45; TWR MN 4HH-1FH-4FM, 169-46; TWR MN 4HH-1FH-4HM-2FM, 169-47; TWR MN 4HH-2FH-2HM-2FM, 169-49; TWR MN 4HH-2FH-3FM, 169-50; TWR MN 4HH-2FH-3FM, 138931-01; TWR MN 4HH-3FH-2FM, 169-52; TWR MN 4HH-4FH-1FM, 169-53; TWR MN 4HH-4FH-1FM, 138940-01; TWR MN 4HH-4HM-3FM, 169-54; TWR MN 4HH-4HM-3FM, 138952-01; TWR MN 4HH-5FH, 169-55; TWR MN 4HH-5FM, 169-56; TWR MN 4HH-5FM, 138918-01; TWR MN 4HH-6HM-2FM, 169-57; TWR MN 4HM-5FM, 169-59; TWR MN 5HH-3HM-3FM, 169-60; TWR MN 5HH-9HM, 138914-01; TWR MN 5HH-9HM, 169-61; TWR MN 6FH-1FM, 169-62; TWR MN 6HH-1FH-2HM-2FM, 169-63; TWR MN 6HH-1FH-3FM, 169-64; TWR MN 6HH-2FH-2FM, 169-65; TWR MN 6HH-4FH, 169-67; TWR MN 6HH-4FH, 138957-01; TWR MN 6HH-4FM, 169-68; TWR MN 6HH-4FM, 138922-01; TWR MN 6HH-4HM-2FM, 169-69; TWR MN 6HH-8HM, 169-71; TWR MN 6HH-8HM, 138958-01; TWR MN 7FH, 169-72; TWR MN 7FH, 138920-01; TWR MN 7FM, 169-73; TWR MN 7FM, 138937-01; TWR MN 7HH-1HM-3FM, 139086-01; TWR MN 7HH-1HM-3FM, 169-74; TWR MN 8HH-1FH-2FM, 169-75; TWR MN 8HH-2FH-1FM, 169-77; TWR MN 8HH-2HM-2FM, 169-78; TWR MN 8HH-2HM-2FM, 138939-01; TWR MN 8HH-3FF, 169-79; TWR MN 8HH-3FH, 169-80; TWR MN 8HH-3FH, 138956-01; TWR MN 8HH-3FM, 169-81; TWR MN 8HH-3FM, 138923-01. BD PYXIS MEDFLEX MN (Name, REF): 1000 12HH, 139055-01; 1000 2HH-2FM, 139041-01; 1000 2HH-5FM, 139046-01; 1000 4HH-4FM, 139049-01; 1000 6HH-3FM, 139051-01; 1000 8HH-2FM, 139052-01; 2000 8HH-2FH, 139165-01; 2000 8HH-2FM, 139069-01. MEDBANK MAIN, 1137-00; MEDBANK MINI MAIN, 1147-00; MEDBANK TOWER MAIN, 1145-00; MEDFLEX, 1119-00; MEDFLEX 2.0, 1139-00
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·March 11, 2025
155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 155159-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 169-101 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 139122-01 BD PYXIS MEDBANK MINI 1HH-1HM-1FM 155160-01 BD PYXIS MEDBANK MINI 1HH-1HM-1FM 169-102 BD PYXIS MEDBANK MINI 1HH-1HM-1FM 138912-01 BD PYXIS MEDBANK MINI 1HH-3HM 155161-01 BD PYXIS MEDBANK MINI 1HH-3HM 169-103 BD PYXIS MEDBANK MINI 1HH-3HM 138902-01 BD PYXIS MEDBANK MINI 2FH 169-104 BD PYXIS MEDBANK MINI 2FH 138903-01 BD PYXIS MEDBANK MINI 2FM 155163-01 BD PYXIS MEDBANK MINI 2FM 169-105 BD PYXIS MEDBANK MINI 2FM 138908-01 BD PYXIS MEDBANK MINI 2HH-1FH 169-106 BD PYXIS MEDBANK MINI 2HH-1FH 138906-01 BD PYXIS MEDBANK MINI 2HH-1FM 155165-01 BD PYXIS MEDBANK MINI 2HH-1FM 169-107 BD PYXIS MEDBANK MINI 2HH-1FM 138907-01 BD PYXIS MEDBANK MINI 2HH-2HM 155166-01 BD PYXIS MEDBANK MINI 2HH-2HM 169-108 BD PYXIS MEDBANK MINI 2HH-2HM 139131-01 BD PYXIS MEDBANK MINI 2HM-1FM 155167-01 BD PYXIS MEDBANK MINI 2HM-1FM 169-109 BD PYXIS MEDBANK MINI 2HM-1FM 139091-01 BD PYXIS MEDBANK MINI 3HH-1FG 155168-01 BD PYXIS MEDBANK MINI 3HH-1FG 169-110 BD PYXIS MEDBANK MINI 3HH-1FG 138909-01 BD PYXIS MEDBANK MINI 3HH-1HM 155169-01 BD PYXIS MEDBANK MINI 3HH-1HM 169-111 BD PYXIS MEDBANK MINI 3HH-1HM 138910-01 BD PYXIS MEDBANK MINI 4HH 155310-01 BD PYXIS MEDBANK MINI 4HH 169-112 BD PYXIS MEDBANK MINI 4HH 138915-01 BD PYXIS MEDBANK MINI 4HM 155171-01 BD PYXIS MEDBANK MINI 4HM 169-113 BD PYXIS MEDBANK MINI 4HM 1147-00 MEDBANK MINI MAIN 138943-01 BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM 155081-01 BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM 169-23 BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM 138955-01 BD PYXIS MEDBANK TWR MN 10HH-2FH 155082-01 BD PYXIS MEDBANK TWR MN 10HH-2FH 169-24 BD PYXIS MEDBANK TWR MN 10HH-2FH 138924-01 BD PYXIS MEDBANK TWR MN 10HH-2FM 155083-01 BD PYXIS MEDBANK TWR MN 10HH-2FM 169-25 BD PYXIS MEDBANK TWR MN 10HH-2FM 138960-01 BD PYXIS MEDBANK TWR MN 12HH-1FF 155084-01 BD PYXIS MEDBANK TWR MN 12HH-1FF 169-26 BD PYXIS MEDBANK TWR MN 12HH-1FF 138961-01 BD PYXIS MEDBANK TWR MN 12HH-1FH 155085-01 BD PYXIS MEDBANK TWR MN 12HH-1FH 169-27 BD PYXIS MEDBANK TWR MN 12HH-1FH 138926-01 BD PYXIS MEDBANK TWR MN 12HH-1FM 155086-01 BD PYXIS MEDBANK TWR MN 12HH-1FM 169-28 BD PYXIS MEDBANK TWR MN 12HH-1FM 138927-01 BD PYXIS MEDBANK TWR MN 14HH 155087-01 BD PYXIS MEDBANK TWR MN 14HH 169-29 BD PYXIS MEDBANK TWR MN 14HH 155293-01 BD PYXIS MEDBANK TWR MN 1FH-10HM-1FM 169-138 BD PYXIS MEDBANK TWR MN 1FH-10HM-1FM 155303-01 BD PYXIS MEDBANK TWR MN 1FM-10HH-1FH 139082-01 BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF 155088-01 BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF 169-30 BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF 155305-01 BD PYXIS MEDBANK TWR MN 2FH-1FM-4HH-2FM 139056-01 BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM 155089-01 BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM 169-31 BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM 155304-01 BD PYXIS MEDBANK TWR MN 2FM-8HH-1FH 139045-01 BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM 155090-01 BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM 169-32 BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM 138932-01 BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM 155091-01 BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM 169-33 BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM 139084-01 BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM 155092-01 BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM 169-34 BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM 138963-01 BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF 155093-01 BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF 169-35 BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF 155294-01 BD PYXIS MEDBANK TWR MN 2HH-4FH-2FM 169-139 BD PYXIS MEDBANK TWR MN 2HH-4FH-2FM 138938-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF 155094-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF 169-36 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF 139125-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM 155095-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM 169-37 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM 138919-01 BD PYXIS MEDBANK TWR MN 2HH-6FM 155096-01 BD PYXIS MEDBANK TWR MN 2HH-6FM 169-38 BD PYXIS MEDBANK TWR MN 2HH-6
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·January 8, 2025
BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-4HH-2FM MP/ 169-145, BD PYXIS MB TWR MN 2FM-8HH-1FH MP/ 169-144, BD PYXIS MB TWR MN 4FH-4HH-1FM MP/ 169-142, BD PYXIS MB TWR RXNOW MAIN W/MED PRINTER / 169-155, BD PYXIS MB TWR RXNOW MAIN W/PAT PRINTER/ 169-156, BD PYXIS MDBANK TWR MN 7HH-1HM-3FM/ 169-132, BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow/ 169-131, BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM/ 169-23, BD PYXIS MEDBANK TWR MN 10HH-2FH/ 169-24, BD PYXIS MEDBANK TWR MN 10HH-2FM/ 169-25, BD PYXIS MEDBANK TWR MN 12HH-1FF/ 169-26, BD PYXIS MEDBANK TWR MN 12HH-1FH/ 169-27, BD PYXIS MEDBANK TWR MN 12HH-1FM/ 169-28, BD PYXIS MEDBANK TWR MN 14HH/ 169-29, BD PYXIS MEDBANK TWR MN 1FH-10HM-1FM/ 169-138, BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF/ 169-30, BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM/ 169-31, BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM/ 169-32, BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM/ 169-33, BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM/ 169-34, BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF/ 169-35, BD PYXIS MEDBANK TWR MN 2HH-4FH-2FM/ 169-139, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF/ 169-36, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM/ 169-37, BD PYXIS MEDBANK TWR MN 2HH-6FM/ 169-38, BD PYXIS MEDBANK TWR MN 2HH-6HM-3FM/ 169-39, BD PYXIS MEDBANK TWR MN 2HH-8HM-2FM/ 169-40, BD PYXIS MEDBANK TWR MN 2HM-6FM/ 169-41, BD PYXIS MEDBANK TWR MN 3FH-4FM/ 169-42, BD PYXIS MEDBANK TWR MN 3FH-8HH MEDPASS/ 169-140, BD PYXIS MEDBANK TWR MN 3HH-7HM-2FM/ 169-43, BD PYXIS MEDBANK TWR MN 4HH-10HM/ 169-44, BD PYXIS MEDBANK TWR MN 4HH-1FH-2HM-3FM/ 169-45, BD PYXIS MEDBANK TWR MN 4HH-1FH-4FM/ 169-46, BD PYXIS MEDBANK TWR MN 4HH-1FH-4HM-2FM/ 169-47, BD PYXIS MEDBANK TWR MN 4HH-1FH-6HM-1FM/ 169-48, BD PYXIS MEDBANK TWR MN 4HH-2FH-2HM-2FM/ 169-49, BD PYXIS MEDBANK TWR MN 4HH-2FH-3FM/ 169-50, BD PYXIS MEDBANK TWR MN 4HH-2HM-4FM/ 169-51, BD PYXIS MEDBANK TWR MN 4HH-3FH-2FM/ 169-52, BD PYXIS MEDBANK TWR MN 4HH-4FH-1FM/ 169-53, BD PYXIS MEDBANK TWR MN 4HH-4HM-3FM/ 169-54, BD PYXIS MEDBANK TWR MN 4HH-5FH / 169-55, BD PYXIS MEDBANK TWR MN 4HH-5FM/ 169-56, BD PYXIS MEDBANK TWR MN 4HH-6HM-2FM/ 169-57, BD PYXIS MEDBANK TWR MN 4HH-8HM-1FM/ 169-58, BD PYXIS MEDBANK TWR MN 4HM-5FM/ 169-59, BD PYXIS MEDBANK TWR MN 5HH-3HM-3FM/ 169-60, BD PYXIS MEDBANK TWR MN 5HH-9HM/ 169-61, BD PYXIS MEDBANK TWR MN 6FH-1FM/ 169-62, BD PYXIS MEDBANK TWR MN 6HH-1FH-2HM-2FM/ 169-63, BD PYXIS MEDBANK TWR MN 6HH-1FH-3FM/ 169-64, BD PYXIS MEDBANK TWR MN 6HH-2FH-2FM/ 169-65, BD PYXIS MEDBANK TWR MN 6HH-2FH-2HM-1FM/ 169-66, BD PYXIS MEDBANK TWR MN 6HH-4FH / 169-67, BD PYXIS MEDBANK TWR MN 6HH-4FM/ 169-68, BD PYXIS MEDBANK TWR MN 6HH-4HM-2FM/ 169-69, BD PYXIS MEDBANK TWR MN 6HH-6HM-1FM/ 169-70, BD PYXIS MEDBANK TWR MN 6HH-8HM/ 169-71, BD PYXIS MEDBANK TWR MN 7FH/ 169-72, BD PYXIS MEDBANK TWR MN 7FM/ 169-73, BD PYXIS MEDBANK TWR MN 7HH-1HM-3FM/ 169-74, BD PYXIS MEDBANK TWR MN 8HH-1FH-2FM/ 169-75, BD PYXIS MEDBANK TWR MN 8HH-1FH-2HM-1FM/ 169-76, BD PYXIS MEDBANK TWR MN 8HH-2FH-1FM/ 169-77, BD PYXIS MEDBANK TWR MN 8HH-2HM-2FM/ 169-78, BD PYXIS MEDBANK TWR MN 8HH-3FF/ 169-79, BD PYXIS MEDBANK TWR MN 8HH-3FH/ 169-80, BD PYXIS MEDBANK TWR MN 8HH-3FM/ 169-81, BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P/ 169-82, BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P/ 169-83, BD PYXIS MEDBANK TWR MN CR-12HH-1FH/ 169-84, BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P/ 169-85, BD PYXIS MEDBANK TWR MN CR-14HH-P/ 169-86, BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM/ 169-87, BD PYXIS MEDBANK TWR MN CR-2HH-6FH/ 169-88, BD PYXIS MEDBANK TWR MN CR-2HH-6FM/ 169-89, BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P/ 169-90, BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P/ 169-91, BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P/ 169-92, BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P/ 169-93, BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P/ 169-94, BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P/ 169-95, BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P/ 169-96, BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P/ 169-97, BD
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·May 13, 2024
Soft Contact Lens
FDA Recall
Terminated
·Cooper Vision Caribbean Corp.·Product code LPM·October 28, 2014
COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code FFF·December 18, 2018
COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code FFF·December 18, 2018
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
FDA Recall
Open, Classified
·Kamiya Biomedical Company, LLC·Product code CFF·September 28, 2022
Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40 UPN Number: M00513332 REF: 1333-40
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FFF·August 28, 2007
V8 Immunodisplacement Kit REF 1803
FDA Recall
Open, Classified
·Helena Laboratories, Corp.·Product code CFF·April 6, 2022
IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. Part Numbers: 446360 (250 test kit) 446260 (50 test kit) 444970 (10 test kit)
FDA Recall
Terminated
·Beckman Coulter Inc·Product code CFF·January 28, 2004
Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 U PN Number: M00513321 REF: 1332-20
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FFF·August 28, 2007
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
FDA Recall
Terminated
·Helena Laboratories, Corp.·Product code CFF·July 21, 2017
Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 20 UPN Number: M00513331 REF: 1333-20
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FFF·August 28, 2007
Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (5499460-10, 5481490-2); D. 3.0T MR750W GEM ENAB (5911000-3); E. 3.0T MR750W GEM ENABLED (5352293, 5481490-2, 5481490-2, 5396469-3, 2394952-100, 5911000-3, 5373011-3); F. 3.0T MR750W GEM ENABLED PLU (5352293); G. 3.0T MR750W GEM ENABLED PLUS (5352293, 5499460-10); H. 3.0T MR750W W GEM (5352293, 5911000-3); I. 3.0T MR750W WITH GEM (5481490-2, 5911000-3); J. 3-0T MR750 32 CHANNEL (5352293); K. 3-0T MR750W FUTURE GEM CAPABLE (5352293, 5911000-3, 5499460-7); L. 3-0T MR750W GEM (5495558, 5352293); M. 3-0T MR750W GEM ENABLED (5911000-3, 5352293, 2394952-100, 5481490-2, 5499460-7, 5373011-3, 5495558, 5481490, 5396469-3, 5481490-3); N. 3-0T MR750W GEM ENABLED PLUS (5911000-3, 5352293, 5499460-10, 5481490-2); O. 3-0T MR750W NON GEM (5911000-3); P. 3T 750W (5921000-2, 5911000-3, 5396469-3, 5352293, 5481490-2, 5481490-3); Q. DISCOVERY MR 750W 3.0T (5481490-2, 5911000-3, 5499460-10); R. DISCOVERY MR750W (5911000-3); S. DISCOVERY MR750W 3 (5481490-2, 5911000-3); T. DISCOVERY MR750W 3T (5911000-3, 5396469-3, 5373011-3, 5481490-2); U. DISCOVERY MR750W GEM (5396469-3, 5352293); V. DISCOVERY MR750W WITH GEM (5911000-3); W. MR 3.0T MR750 W (5352293); X. MR 3.0T MR750W GEM ENABLED (5911000-3, 5352293); Y. MR 3-0T MR750W (5911000-3); Z. MR DISCOVERY 750W GEM (5911000-3); AA. MR OPTIMA MR750W 3.0T (5911000-3); BB. MR750W (5911000-3); CC. MR750W GEM ENABLED (5911000-3, 5499460-7); DD. MR750W GEM ENABLED PLUS (5352293); EE. MR750W PGR 32-CHANNEL (5911000-3); FF. 3.0T MR750W GEM ENAB (5911000-3) Product Usage: The Discovery MR750w 3.0T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750w 3.0T system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance..
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code LNH·June 6, 2018
MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI 1HH-1FH- 1HM, REF: 169-101; BD PYXIS MEDBANK MINI 1HH-1HM- 1FM, REF: 169-102; BD PYXIS MEDBANK MINI 1HH-3HM, REF: 169-103; BD PYXIS MEDBANK MINI 2FH, REF: 169-104; BD PYXIS MEDBANK MINI 2FM, REF: 169-105; BD PYXIS MEDBANK MINI 2HH-1FH, REF: 169-106; BD PYXIS MEDBANK MINI 2HH-1FM , REF: 169-107; BD PYXIS MEDBANK MINI 2HH-2HM, REF: 169-108; BD PYXIS MEDBANK MINI 2HM-1FM, REF: 169-109; BD PYXIS MEDBANK MINI 3HH-1FG, REF: 169-110; BD PYXIS MEDBANK MINI 3HH-1HM, REF: 169-111; BD PYXIS MEDBANK MINI 4HH, REF: 169-112; BD PYXIS MEDBANK MINI 4HM, REF: 169-113; BD PYXIS MDBANK TWR MN 7HH-1HM-3FM RxNow, REF: 169-132; BD PYXIS MEDBANK MINI 1FH-1FM, REF: 169-137; BD PYXIS MEDBANK TWR MN 1FH- 10HM-1FM, REF: 169-138; BD PYXIS MEDBANK TWR MN 2HH- 4FH-2FM, REF: 169-139; OBS BD PYXIS MB TOWER MAIN, REF: 169-153; OBS BD PYXIS MB TWR RXNOW MAIN W/MED PRI, REF: 169-155; OBS BD PYXIS MB TWR RXNOW MAIN W/PAT PRI, REF: 169-156; OBS BD PYXIS MB MINI MAIN W/CUBIE DRWS, REF: 169-159; OBS BD PYXIS MB MINI MAIN W/MATRIX DRWS, REF: 169-160; OBS BD PYXIS MB MINI MAIN W/HH FALSE DRW, REF: 169-161; OBS BD PYXIS MB MINI MAIN W/FH FALSE DRW, REF: 169-162; BD PYXIS MEDBANK TWR MN 10HH- 1FH-1FM, REF: 169-23; BD PYXIS MEDBANK TWR MN 10HH- 2FH, REF: 169-24; BD PYXIS MEDBANK TWR MN 10HH- 2FM, REF: 169-25; BD PYXIS MEDBANK TWR MN 12HH- 1FF, REF: 169-26; BD PYXIS MEDBANK TWR MN 12HH- 1FH, REF: 169-27; BD PYXIS MEDBANK TWR MN 12HH- 1FM, REF: 169-28; BD PYXIS MEDBANK TWR MN 14HH, REF: 169-29; BD PYXIS MEDBANK TWR MN 1HH- 1HM-2FM-4FF, REF: 169-30; BD PYXIS MEDBANK TWR MN 2FH- 2HM-4FM, REF: 169-31; BD PYXIS MEDBANK TWR MN 2HH- 10HM-1FM, REF: 169-32; BD PYXIS MEDBANK TWR MN 2HH- 1FH-5FM, REF: 169-33; BD PYXIS MEDBANK TWR MN 2HH- 2FH-4FM, REF: 169-34; BD PYXIS MEDBANK TWR MN 2HH- 2FM-4FF, REF: 169-35; BD PYXIS MEDBANK TWR MN 2HH- 4HM-4FF, REF: 169-36; BD PYXIS MEDBANK TWR MN 2HH- 4HM-4FM, REF: 169-37; BD PYXIS MEDBANK TWR MN 2HH- 6FM, REF: 169-38; BD PYXIS MEDBANK TWR MN 2HH- 6HM-3FM, REF: 169-39; BD PYXIS MEDBANK TWR MN 2HH- 8HM-2FM, REF: 169-40; BD PYXIS MEDBANK TWR MN 2HM- 6FM, REF: 169-41; BD PYXIS MEDBANK TWR MN 3FH-4FM , REF: 169-42; BD PYXIS MEDBANK TWR MN 3HH- 7HM-2FM, REF: 169-43; BD PYXIS MEDBANK TWR MN 4HH- 10HM, REF: 169-44; BD PYXIS MEDBANK TWR MN 4HH- 1FH-2HM-3FM, REF: 169-45; BD PYXIS MEDBANK TWR MN 4HH- 1FH-4FM, REF: 169-46; BD PYXIS MEDBANK TWR MN 4HH- 1FH-4HM-2FM, REF: 169-47; BD PYXIS MEDBANK TWR MN 4HH- 1FH-6HM-1FM, REF: 169-48; BD PYXIS MEDBANK TWR MN 4HH- 2FH-2HM-2FM, REF: 169-49; BD PYXIS MEDBANK TWR MN 4HH- 2FH-3FM, REF: 169-50; BD PYXIS MEDBANK TWR MN 4HH- 2HM-4FM, REF: 169-51; BD PYXIS MEDBANK TWR MN 4HH- 3FH-2FM, REF: 169-52; BD PYXIS MEDBANK TWR MN 4HH- 4FH-1FM, REF: 169-53; BD PYXIS MEDBANK TWR MN 4HH- 4HM-3FM, REF: 169-54; BD PYXIS MEDBANK TWR MN 4HH-5FH, REF: 169-55; BD PYXIS MEDBANK TWR MN 4HH- 5FM, REF: 169-56; BD PYXIS MEDBANK TWR MN 4HH- 6HM-2FM, REF: 169-57; BD PYXIS MEDBANK TWR MN 4HH- 8HM-1FM, REF: 169-58; BD PYXIS MEDBANK TWR MN 4HM- 5FM, REF: 169-59; BD PYXIS MEDBANK TWR MN 5HH- 3HM-3FM, REF: 169-60; BD PYXIS MEDBANK TWR MN 5HH- 9HM, REF: 169-61; BD PYXIS MEDBANK TWR MN 6FH-1FM, REF: 169-62; BD PYXIS MEDBANK TWR MN 6HH- 1FH-2HM-2FM, REF: 169-63; BD PYXIS MEDBANK TWR MN 6HH- 1FH-3FM, REF: 169-64; BD PYXIS MEDBANK TWR MN 6HH- 2FH-2FM, REF: 169-65; BD PYXIS MEDBANK TWR MN 6HH- 2FH-2HM-1FM, REF: 169-66; BD PYXIS MEDBANK TWR MN 6HH-4FH, REF: 169-67; BD PYXIS MEDBANK TWR MN 6HH- 4FM, REF: 169-68; BD PYXIS MEDBANK TWR MN 6HH- 4HM-2FM, REF: 169-69; BD PYXIS MEDBANK TWR MN 6HH- 6HM-1FM, REF: 169-70; BD PYXIS MEDBANK TWR MN 6HH- 8HM, REF: 169-71; BD PYXIS MEDBANK TWR MN 7FH, REF: 169-72; BD PYXIS M
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·October 5, 2023
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-2HM/169-108, BD PYXIS MEDBANK MINI 2HH-1FM/169-107, BD PYXIS MEDBANK MINI 2HH-1FH/169-106, BD PYXIS MEDBANK MINI 2FM/169-105, BD PYXIS MEDBANK MINI 2FH/169-104, BD PYXIS MEDBANK MINI 1HH-3HM/169-103, BD PYXIS MEDBANK MINI 1HH-1HM-1FM/169-102, BD PYXIS MEDBANK MINI 1HH-1FH-1HM/169-101 , BD PYXIS MEDBANK MINI 1FH-2HH/155311-01, BD PYXIS MEDBANK MINI 4HH/155310-01, BD PYXIS MEDBANK MINI 1FH-1FM/155288-01, BD PYXIS MEDBANK MINI 4HM/155171-01, BD PYXIS MEDBANK MINI 3HH-1HM/155169-01, BD PYXIS MEDBANK MINI 3HH-1FG/155168-01, BD PYXIS MEDBANK MINI 2HM-1FM/155167-01, BD PYXIS MEDBANK MINI 2HH-2HM/155166-01, BD PYXIS MEDBANK MINI 2HH-1FM/155165-01, BD PYXIS MEDBANK MINI 2FM/155163-01, BD PYXIS MEDBANK MINI 1HH-3HM/155161-01, BD PYXIS MEDBANK MINI 1HH-1HM-1FM/155160-01, BD PYXIS MEDBANK MINI 1HH-1FH-1HM/155159-01, BD PYXIS MEDBANK MINI 2HM-1FM/139131-01, BD PYXIS MEDBANK MINI 1HH-1HM-1FM/139122-01, BD PYXIS MEDBANK MINI 3HH-1FG/139091-01, BD PYXIS MEDBANK MINI 1HH-1FH-1HM/138921-01, BD PYXIS MEDBANK MINI 4HM/138915-01, BD PYXIS MEDBANK MINI 1HH-3HM/138912-01, BD PYXIS MEDBANK MINI 4HH/138910-01, BD PYXIS MEDBANK MINI 3HH-1HM/138909-01, BD PYXIS MEDBANK MINI 2HH-1FH/138908-01, BD PYXIS MEDBANK MINI 2HH-2HM/138907-01, BD PYXIS MEDBANK MINI 2HH-1FM/138906-01, BD PYXIS MEDBANK MINI 2FM/138903-01, BD PYXIS MEDBANK MINI 2FH/138902-01, MEDBANK MINI MAIN/1147-00, MEDBANK MAIN/1137-00, BD PYXIS MEDBANK TWR MN 8HH-3FM/169-81, BD PYXIS MEDBANK TWR MN 8HH-3FH/169-80, BD PYXIS MEDBANK TWR MN 8HH-3FF/169-79, BD PYXIS MEDBANK TWR MN 8HH-2HM-2FM/169-78, BD PYXIS MEDBANK TWR MN 8HH-2FH-1FM/169-77, BD PYXIS MEDBANK TWR MN 8HH-1FH-2HM-1FM/169-76, BD PYXIS MEDBANK TWR MN 8HH-1FH-2FM/169-75, BD PYXIS MEDBANK TWR MN 7HH-1HM-3FM/169-74, BD PYXIS MEDBANK TWR MN 7FM/169-73, BD PYXIS MEDBANK TWR MN 7FH/169-72, BD PYXIS MEDBANK TWR MN 6HH-8HM/169-71, BD PYXIS MEDBANK TWR MN 6HH-6HM-1FM/169-70, BD PYXIS MEDBANK TWR MN 6HH-4HM-2FM/169-69, BD PYXIS MEDBANK TWR MN 6HH-4FM/169-68, BD PYXIS MEDBANK TWR MN 6HH-4FH /169-67, BD PYXIS MEDBANK TWR MN 6HH-2FH-2HM-1FM/169-66, BD PYXIS MEDBANK TWR MN 6HH-2FH-2FM/169-65, BD PYXIS MEDBANK TWR MN 6HH-1FH-3FM/169-64, BD PYXIS MEDBANK TWR MN 6HH-1FH-2HM-2FM/169-63, BD PYXIS MEDBANK TWR MN 6FH-1FM/169-62, BD PYXIS MEDBANK TWR MN 5HH-9HM/169-61, BD PYXIS MEDBANK TWR MN 5HH-3HM-3FM/169-60, BD PYXIS MEDBANK TWR MN 4HM-5FM/169-59, BD PYXIS MEDBANK TWR MN 4HH-8HM-1FM/169-58, BD PYXIS MEDBANK TWR MN 4HH-6HM-2FM/169-57, BD PYXIS MEDBANK TWR MN 4HH-5FM/169-56, BD PYXIS MEDBANK TWR MN 4HH-5FH /169-55, BD PYXIS MEDBANK TWR MN 4HH-4HM-3FM/169-54, BD PYXIS MEDBANK TWR MN 4HH-4FH-1FM/169-53, BD PYXIS MEDBANK TWR MN 4HH-3FH-2FM/169-52, BD PYXIS MEDBANK TWR MN 4HH-2HM-4FM/169-51, BD PYXIS MEDBANK TWR MN 4HH-2FH-3FM/169-50, BD PYXIS MEDBANK TWR MN 4HH-2FH-2HM-2FM/169-49, BD PYXIS MEDBANK TWR MN 4HH-1FH-6HM-1FM/169-48, BD PYXIS MEDBANK TWR MN 4HH-1FH-4HM-2FM/169-47, BD PYXIS MEDBANK TWR MN 4HH-1FH-4FM/169-46, BD PYXIS MEDBANK TWR MN 4HH-1FH-2HM-3FM/169-45, BD PYXIS MEDBANK TWR MN 4HH-10HM/169-44, BD PYXIS MEDBANK TWR MN 3HH-7HM-2FM/169-43, BD PYXIS MEDBANK TWR MN 3FH-4FM/169-42, BD PYXIS MEDBANK TWR MN 2HM-6FM/169-41, BD PYXIS MEDBANK TWR MN 2HH-8HM-2FM/169-40, BD PYXIS MEDBANK TWR MN 2HH-6HM-3FM/169-39, BD PYXIS MEDBANK TWR MN 2HH-6FM/169-38, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM/169-37, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF/169-36, BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF/169-35, BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM/169-34, BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM/169-33, BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM/169-32, BD PY
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·July 10, 2025