BEUDAMED
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    DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.

    FDA Recall
    Open, Classified ·Nuclein LLC·Product code QOF·June 25, 2025

    In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QOF·February 1, 2023

    The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QOF·November 27, 2023

    Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code QOF·March 12, 2025

    BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QOF·May 8, 2023

    Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code QOF·November 8, 2024

    BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QOF·October 22, 2025

    Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QOF·April 1, 2026

    1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code GCJ·January 14, 2022

    Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;

    FDA Recall
    Open, Classified ·Bayer Medical Care, Inc.·Product code DXT·April 24, 2026

    exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy.

    FDA Recall
    Open, Classified ·Exocad GmbH Julius-Reiber-Str. 37 Darmstadt Germany·Product code LLZ·August 17, 2023

    Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular. (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile; (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile; (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile; (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile; (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile; (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile; (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile; (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile; (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile; (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile; (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile; (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile; (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile; (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile; (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile; (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile; (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile; (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile; (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile; (22) Presource OR Percutaneous Pack, Cat. SAN53OPVMG, Virginia Mason Medical Center, Sterile; (23) Presource Pacemaker Pack, Cat. SAN55PMMMK, KP Maui Memorial Medical Cente, Sterile; (24) Presource Pacemaker Pack, Cat. SAN55PMMM9, KP Maui Memorial Medical Cente, Sterile; (25) Presource Pacemaker Insertion Pack, Cat. SAN57PM80G, Salem Health, Sterile; (26) Presource Endovascular Pack, Cat. SAN69ENKBK, KP Baldwin Park Med Cntr, Sterile (27) Presource Vascular Procedure Pack, Cat. SCVOCVACMI, Starling Physicians Access Cen, Sterile; (28) Presource HFHS Vasc Access Endo Vasc Pk, Cat. SCVW1VAHFL, Henry Ford Health System, Sterile; (29) Presource AV Access Pack, Cat. SCV11AVDMF, Suny Downstate, Sterile; (30) Presource AV Access Pack, Cat. SCV11AVD13, Suny Downstate, Sterile; (31) Presource TAVR Bundle Pack, Cat. SCV11TBTJH, Part 1 of 2 and Part 2 of 2, Thomas Jefferson University, Sterile; (32) Presource EVAR, Cat. SCV30EVTHE, Trillium Health Centre, Sterile; (33) Presource RHS Pacemaker, Cat. SCV30PMRGA, Richmond Hospital, Sterile; (34) Presource Perc Pack, Cat. SOT30PCHSC, Health Science Centre, Sterile.

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code OEZ·August 16, 2023

    Identity Imprint PS Tibial Tray Size 4: Lot 540287

    FDA Recall
    Open, Classified ·Conformis, Inc.·Product code JWH·March 11, 2024

    BD Alaris Syringe Module, REF 8110

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·September 15, 2023

    Alaris PCA Module 8120

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·September 15, 2023

    BD Alaris PCU REF 8015

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·September 15, 2023

    LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.

    FDA Recall
    Open, Classified ·Magellan Diagnostics, Inc.·Product code DOF·September 19, 2023

    Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716

    FDA Recall
    Open, Classified ·EBI, LLC·Product code LOF·March 22, 2024

    (1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50 @) " Transfer Droppers (50 @) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)

    FDA Recall
    Open, Classified ·Magellan Diagnostics, Inc.·Product code DOF·March 13, 2026

    LeadCare Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)

    FDA Recall
    Open, Classified ·Magellan Diagnostics, Inc.·Product code DOF·March 13, 2026