18 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·May 21, 2024
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·February 11, 2026
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·November 6, 2025
BD Alaris PCU REF 8015
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·September 15, 2023
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·January 24, 2023
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code PHC·February 18, 2025
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code PHC·February 18, 2025
GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF GC00113; f) 95 Multichroma 16LB2, REF GC00131; g) 95 Multichroma 14LA2, REF GC00157; h) 95 Multichroma 20LB2, REF GC00098; i) 95 Multichroma 20LBL2, REF GC00114; j) 95 Multichroma 16LA3,5, REF GC00132; k) 95 Multichroma 14LA1, REF GC00158; l) 95 Multichroma 24LB1, REF GC00099; m) 95 Multichroma 20LA3,5, REF GC00115; n) 95 Multichroma 16LA3, REF GC00133; o) 95 Multichroma 16LC2, REF GC00091; p) 95 Multichroma 14LBL2, REF GC00134; q) 95 Multichroma 24LBL2, REF GC00092; r) 95 Multichroma 24LA3,5, REF GC00101; s) 95 Multichroma 20LA3, REF GC00117; t) 95 Multichroma 14LB1, REF GC00135; u) 95 Multichroma 24LB2, REF GC00094; v) 95 Multichroma 20LA2, REF GC00119; w) 95 Multichroma14LA3,5, REF GC00137; x) 95 Multichroma 14LC2, REF GC00095; y) 95 Multichroma 24LA3, REF GC00104; z) 95 Multichroma14LA3, REF GC00138 ; used in the manufacture of dentures.
FDA Recall
Open, Classified
·GRAPHENANO DENTAL SL Calle De Pau Casals·Product code EBI·October 24, 2023
In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe, REF 05J03-004; (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022;
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code MVU·February 1, 2024
BD Recanalization System, REF: BDRECANSYSTEM
FDA Recall
Open, Classified
·Bard Peripheral Vascular Inc·Product code PDU·November 14, 2023
Herpes (HSV-1 & HSV-2) Test
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code MVU·November 3, 2025
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
FDA Recall
Open, Classified
·Becton, Dickinson and Company, BD Biosciences·Product code MVU·October 25, 2023
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
FDA Recall
Open, Classified
·Kreatech Biotechnology Bv Vlierweg 20 Amsterdam Netherlands·Product code MVU·November 1, 2024
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
FDA Recall
Open, Classified
·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code MVU·May 24, 2023
BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.
FDA Recall
Open, Classified
·Becton, Dickinson and Company, BD Biosciences·Product code MVU·March 25, 2022
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
FDA Recall
Open, Classified
·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code MVU·March 19, 2021
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
FDA Recall
Open, Classified
·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code MVU·May 24, 2023
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.
FDA Recall
Open, Classified
·Becton, Dickinson and Company, BD Biosciences·Product code MVU·March 25, 2022