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    AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

    FDA Recall
    Terminated ·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code JIF·July 30, 2020

    AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

    FDA Recall
    Terminated ·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code JIF·July 30, 2020

    A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code GCP·August 18, 2017

    MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL; PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL; KIT MMT-1896WW MM780G 6.5W BLE SF MG; PUMP MMT-1884XC 780G V6.5 CLIN US MG; PUMP MMT-1885XC 780G V6.5 CLIN MM; PUMP MMT-1886XC 780G V6.5 CLIN MG; PUMP MMT-1885L MM780G 6.5V BLE MMOL; PUMP MMT-1886L MM780G 6.5W BLE MG; KIT MMT-1896ES MM780G V6.5W MG; KIT MMT-1896WWA MM780G BLE MG ES; KIT MMT-1895WWA MM780G BLE MMOL AR; KIT MMT-1895WWA MM780G BLE MMOL CS; KIT MMT-1895WWA MM780G BLE MMOL DA; KIT MMT-1895WWA MM780G BLE MMOL DE; KIT MMT-1895WWA MM780G BLE MMOL EN; KIT MMT-1895WWA MM780G BLE MMOL FI; KIT MMT-1895WWA MM780G BLE MMOL FR; KIT MMT-1895WWA MM780G BLE MMOL IT; KIT MMT-1895WWA MM780G BLE MMOL NL; KIT MMT-1895WWA MM780G BLE MMOL NO; KIT MMT-1895WWA MM780G BLE MMOL SL; KIT MMT-1895WWA MM780G BLE MMOL SV; KIT MMT-1895WWA MM780G BLE MMOL HU; KIT MMT-1896WWA MM780G BLE MG AR; KIT MMT-1896WWA MM780G BLE MG DE; KIT MMT-1896WWA MM780G BLE MG EL; KIT MMT-1896WWA MM780G BLE MG HE; KIT MMT-1896WWA MM780G BLE MG IT; KIT MMT-1896WWA MM780G BLE MG PL; KIT MMT-1896WWA MM780G BLE MG RO; KIT MMT-1896WWA MM780G BLE MG TR; KIT MMT-1896WWA MM780G BLE MG NL; KIT MMT-1896WWA MM780G BLE MG FR; KIT MMT-1896WWA MM780G BLE MG ES;

    FDA Recall
    Open, Classified ·Medtronic Minimed·Product code OZP·March 15, 2021

    BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code JSI·June 6, 2013

    BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.

    FDA Recall
    Terminated ·Prism Medical Services USA·Product code FSA·May 23, 2013

    BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.

    FDA Recall
    Terminated ·Prism Medical Services USA·Product code FSA·May 23, 2013

    BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.

    FDA Recall
    Terminated ·Prism Medical Services USA·Product code FSA·May 23, 2013

    BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.

    FDA Recall
    Terminated ·Prism Medical Services USA·Product code FSA·May 23, 2013

    Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.

    FDA Recall
    Terminated ·RF Technologies, Inc.·Product code KMI·May 17, 2013

    Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·May 4, 2012

    Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·May 4, 2012

    Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·May 4, 2012

    Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·May 4, 2012

    Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·May 4, 2012

    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

    FDA Recall
    Open, Classified ·Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark·Product code NJT·August 11, 2025

    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

    FDA Recall
    Open, Classified ·Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark·Product code NJT·August 11, 2025

    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

    FDA Recall
    Open, Classified ·Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark·Product code NJT·August 11, 2025

    Custom Dialysis prep kits labeled as follows: ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP 5-12, BIN 34B; COMMUNITY-CATH, 150/CS, LOT #K1052, EXP 5-12, BIN 36B; COLUMBUS-CATH, 50/CS, LOT #1080, EXP 05-12, BIN 39B; RENALSG-CATH, 75/CS, LOT #L1046, EXP 6-12, BIN 40B; SUNYDOWN-HEMO, 100/CS, LOT #l1015, EXP 6-12, BIN 28A; KIDNEYCARE 125/CS, LOT #l1070, EXP 6-12; METHODIST-CATH, 75/CS, LOT #L1072, EXP 6-12; METHODIST-HEMO, 150/CS, LOT #L1073, EXP 6-12; MERCYMED-CATH, 75/CS, LOT #L1077, EXP 6-12, BIN 39A and SANTACLA-CATH, 75/CS, LOT #A1118, EXP 7-12, BIN 44A. Product Usage: custom dialysis prep kits

    FDA Recall
    Terminated ·Lee Medical International Inc·Product code FKG·August 15, 2011

    Custom dialysis prep kits labeled as follows: KIDNEYCARE, 125/CS, LOT #A1160, EXP 7-12, BIN 35A, Lee Medical International, Inc., New Orleans, LA 70123 MESCALERO-HEMO, 200/CS, LOT #B1113, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 DAV-MT-POCONO-H, 200/CS, LOT #B1123, EXP 8-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123 ADV-CATH-ISL44, 100/CS, LOT #B1127 EXP 8-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123 ADV-HEMO-15G, 100/CS, LOT #B1128, EXP 8-12, BIN 34A, Lee Medical International, Inc., New Orleans, LA 70123 NORTHHUDSON-C, 100/CS, LOT #B1134, EXP 8-12, BIN 42B, Lee Medical International, Inc., New Orleans, LA 70123 NORTHHUDSON-H, 75/CS, LOT #B1135, EXP 8012, BIN 42B, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-HEMO, SMALL GLOVES, LOT #B1143, B1144, and B1145. EXP 8-12, 100/CS, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-HEMO, MEDIUM GLOVES, LOT #B1146 and B1147, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-SUB, SMALL GLOVES, 100/CS, LOT #B1148, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-SUB, SMALL GLOVES, LOT #B1149, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 SNCH-CATH, 50/CS, LOT #B1152, EXP 8-12, BIN 43A, Lee Medical International, Inc., New Orleans, LA 70123 COMMUNITY-HEMO, 125/CS, LOT #B1156, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 FLAMS-HEMO, 125/CS. LOT #B1162, EXP 8-12, BIN 38B, Lee Medical International, Inc., New Orleans, LA 70123 KINDEYSPA-HEMO, 125/CS, LOT #B1161, EXP 8-12, BIN 35B, Lee Medical International, Inc., New Orleans, LA 70123 DAV-POCONO-H, 500/CS, LOT #C1107, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 DAV-POCONO-CATH, 75/CS, LOT #C1108, EXP 9-12, BIN 43B, Lee Medical International, Inc., New Orleans, LA 70123 DAV-MT-POCONO-H, 200/CS, LOT #C1109, EXP 9-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123 MESCALERO-HEMO, 200/CS, LOT #C1110, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 KIDNEYTRMT-HEMO, 125/CS, LOT #C1112 and C1123, EXP 9-12, BIN 45A, Lee Medical International, Inc., New Orleans, LA 70123 DAV-POCONO-H, 500/CS, LOT #C1126, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 METHODIST-HEMO, 150/CS, LOT #C1139, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 KINGMAN-HEMO, 150/CS, LOT #C1141, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 DAV-PALMERTON-H, 200/CS, LOT #C1145, EXP 9-12, BIN 43B, Lee Medical International, Inc., New Orleans, LA 70123 EMANUEL-CATH, 100/CS, LOT #C1146, EXP 9-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123 Product Usage: custom dialysis prep kits

    FDA Recall
    Terminated ·Lee Medical International Inc·Product code FKG·March 22, 2011