BEUDAMED
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    Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDP·October 11, 2011

    (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·January 8, 2025

    BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JQP·March 9, 2022

    Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460

    FDA Recall
    Open, Classified ·Davol, Inc.·Product code FTL·April 25, 2023

    Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450

    FDA Recall
    Open, Classified ·Davol, Inc.·Product code FTL·April 25, 2023

    BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTC·March 22, 2023

    BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200

    FDA Recall
    Open, Classified ·Becton Dickinson & Company·Product code JKA·January 6, 2022

    Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955460G (EU Only)

    FDA Recall
    Open, Classified ·Davol, Inc.·Product code FTL·April 25, 2023

    BD Synapsys Informatics Solution, Catalog Number 444150

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·June 8, 2023

    Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU only)

    FDA Recall
    Open, Classified ·Davol, Inc.·Product code FTL·April 25, 2023

    BD Alaris Pump Module REF 8100 The BD Alaris 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

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·January 23, 2025

    BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·September 12, 2024

    BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code LON·September 23, 2025

    BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code OZN·September 23, 2025

    Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0)) 3. BD 20ml Syringe.

    FDA Recall
    Terminated ·Theken Spine LLC·Product code KNW·August 27, 2008

    BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code MDB·September 23, 2025

    BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code NJR·December 11, 2012

    BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Kirby antimicrobial disc susceptibility test procedure, the oxacillin screen test may be conveniently performed on isolates at the same time as routine susceptibility testing.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code JTZ·April 20, 2011

    BD BACTEC(tm) MGI (tm) System Software, Catalog 445922, Lot V5.02A. Product Usage: The BACTEC(tm) MGIT (tm) System Software is used in the MGIT 960 and MGIT 320 instruments for the rapid detection of mycobacteria from clinical specimens. In addition, an Antimicrobial/Drug Susceptibility Testing (AST or DST) system is used as a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and a tube for each drug, as well as a barcoded tube carrier that holds the set. The carrier barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. Large or small AST carrier sets can be placed in the rack. The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code MDB·March 28, 2011

    BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code LLH·May 22, 2012