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    Battery-operated Cautery Low Temperature, fine/elongated Tip

    FDA Recall
    Terminated ·Aaron Medical Industries, Inc.·Product code HQP·June 29, 2004

    Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arresting bleeding from small vessels by heat conducted through the wire tip. Indications include ophthalmic, general and plastic surgery.

    FDA Recall
    Terminated ·Beaver Visitec·Product code HQP·July 19, 2018

    Battery-operated Cautery High Temperature, fine/Loop/ Vasectomy Tip

    FDA Recall
    Terminated ·Aaron Medical Industries, Inc.·Product code HQP·June 29, 2004

    OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the Sure Check hCG Midstream Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic ''wand'' with an absorbent wick at one end. The device is packaged in a foil pouch with desiccant. Catalog numbers are solely used for ordering by the different distributors. This OTC product is shipped as either bulk packaged product or as private labeled material labeled as follows: (1) SURE CHECK™ ONE STEP Pregnancy Test --- 1 TEST; MANUFACTURED BY CHEMBIO DIAGNOSTIC SYSTEMS, INC. MEDFORD, NY 11763 MADE IN USA; UPC 6 07158 00110 3; Catalog # PT110SURE/12 (ordered by Dean Distribution, Fred's DC Memphis, Health Enterprises, Healthcare Products, Mason Distribution, Par-Med). (2) SURE CHECK™ ONE STEP Pregnancy Test --- 2 TESTS; MANUFACTURED BY CHEMBIO DIAGNOSTIC SYSTEMS, INC. MEDFORD, NY 11763 MADE IN USA; UPC 6 07158 00112 7; Catalog # PT112/24 (Fred's DC Memphis). (3) exact™ pregnancy test --- Product of U.S.A./Produit des E-U. Prepared for/Prepare pour LOBLAWS INC. Montreal H4N 3L4, Toronto M4T 2S8, Calgary T2E 7S9, Canada By/Par Chembio Diagnostics Systems, Medford, New York 11763 Imported by/Import par Le Group Neuco Image Inc., Montreal, Quebec H2P 2T4 Canada; UPC 0 60383 66207 3; Catalog # PT110-N4 (Neuco). (4) exact™ pregnancy test --- 2 tests; Product of U.S.A./Produit des E-U. Prepared for/Prepare pour LOBLAWS INC. Montreal H4N 3L4, Toronto M4T 2S8, Calgary T2E 7S9, Canada By/Par Chembio Diagnostics Systems, Medford, New York 11763 Imported by/Import par Le Group Neuco Image Inc., Montreal, Quebec H2P 2T4 Canada; UPC 0 60383 68179; Catalog # PT112-N4 (Neuco). (5) OUR BEST NOTRE MEILLEUR ONE STEP PREGNANCY TEST (TEST DE GROSSESSE EN UNE ETAPE) --- 1 TEST --- PRODUCT OF U.S.A./PRODUIT DES E.-U. IMPORTED FOR/IMPORTE POUR: SOBEYS MISSISSAUGA, ON L4V 1W2. Manufactured by/Fabriqu par: CHEMBIO DIAGNOSTIC SYSTEMS, INC.; UPC 0 61925 57608; Catalog # PT110-N7 (Neuco). (6) BODY BASICS™ Pregnancy Test (Test de grossesse) --- 1 Test --- PRODUCT OF U.S.A./PRODUIT DES E.-U.A. MANUFACTURED BY/FABRIQUE PAR: CHEMBIO DIAGNOSTIC SYSTEMS, INC. IMPORTED FOR/IMPORTE POUR: THE GREAT ATLANTIC & PACIFIC COMPANY OF CANADA LTD. TORONTO, CANADA M5W1A6; UPC 0 57627 71110 9; Catalog # PT110-N6/12 (Neuco) (7) Option+ TEST DE GROSSESSE UNE ETAPE/ONE STEP PREGNANCY TEST --- Produit des E.U/Product of U.S.A. Fabrique pour/Manufactured for: UNIPRIX Inc. Montreal H1S 3G7; UPC 7 71290 05402 7; Catalog # PT110-N2 (Neuco). (8) True-Test™ Pregnancy Test Kit (Examen del Embarazo) One Step Testing --- 1 Test --- Distributed By: Ultras Pharmaceuticals, Inc. P.O. Box 370669 Las Vegas, NV 89137 U.S.A.; UPC 0 61406 37505 5; Catalog # PT110-R1 (Ultras). (9) Shaw's ONE-STEP Pregnancy Test ---1 TEST --- DISTRIBUTED BY SHAW'S SUPERMARKETS, INC. E. BRIDGEWATER, MA 02333, Made in USA; UPC 0 45674 65589 7; Catalog # PT110-S1 (Millbrook Distribution). (10) Harris Teeter Pregnancy Test Kits One Step Easy to use Pregnancy Test Kit --- Two Home Test Kits --- PROUDLY DISTRIBUTED BY: HARRIS TEETER MATTHEWS, NC 28105; UPC 0 72036 72061 0; Catalog # PT112-R2 (Harris Teeter). Bulk packaged product is assigned Catalog # PT110, with varying quantities (ordered by Savyon Diagnostics & Pruebas Moderna del Istmo). --- 510(k) K961965.

    FDA Recall
    Terminated ·Chembio Diagnostic System Inc·Product code LCX·October 6, 2004

    CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code GJS·May 16, 2013

    Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code QJR·April 28, 2025

    ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE WITH POUCH UF (1) PLATFORM TRAY LARGE (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) BAG BAND RUBBAN & TAPE UF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (5) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL DURAPREP SOLUTION 6ML LIF (1) SAFETY SCALPEL #11 STAINLESS STEEL (2) GOWN STANDARD SMS LARGE VELCRO NECK (1) MANIFOLD WITH CONTROL SYRINGE (1) NEEDLE 18G X 2% AMC/4 (2) UTILITY BOWL 16oz UF (2) CLOTH HUCK TOWEL BLUE (2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF (2) MEDICINE CUP 2oz LIF (30) GAUZE SPONGE 4" X 4" 16PL Y (1) NEEDLE HYPODEMIC 18G X 1 ~ (4) TOWEL CLAMP (2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF (1) HALSTED MOSQUITO CVD 5" SERRAT (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (2) NEEDLE HYPODERMIC 22G X 1 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·May 20, 2014

    Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21. Model Number: CHAIR-0-SC2-030; Advance Chair, 100mm (4in) Castors, Std Backrest, Electric; Serial Numbers: 10001-SC2-20 to 10135-SC2-20; 10001-SC2-21 to 10240-SC2-21. Model Number: CHAIR-0-SC3-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Manual; Serial Numbers: 10116-SC3-20 to 10145-SC3-20; 10236-SC3-20 to 10295-SC3-20; 10001-SC3-21 to 10090-SC3-21; 10271-SC3-21 to 10360-SC3-21; 10001-SC3-20 to 10115-SC3-20; 10146-SC3-20 to 10235-SC3-20. Model Number: CHAIR-0-SC4-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Electric; Serial Numbers: 10001-SC4-20 to 10030-SC4-20.

    FDA Recall
    Open, Classified ·Accora Inc·Product code INM·June 21, 2021

    NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800

    FDA Recall
    Open, Classified ·NeuMoDx Molecular Inc·Product code QJR·May 15, 2023

    Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.

    FDA Recall
    Terminated ·Battelle Memorial Institute·Product code QKY·August 13, 2020

    Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code HGP·November 21, 2022

    Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.

    FDA Recall
    Terminated ·Vital Signs Devices, a GE Healthcare Company·Product code HGP·October 16, 2012

    Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA

    FDA Recall
    Terminated ·Cardinal Health·Product code HAP·November 15, 2003

    Fetal Spiral Electrode, Model No. 9898 031 37631

    FDA Recall
    Terminated ·Philips North America, LLC·Product code HGP·January 25, 2019

    Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code NBW·September 30, 2019

    Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink iPro software is used to upload glucose sensor data stored on a recording device, capture BG meter readings through manual entry or wired-upload, retrospectively calibrate sensor data, and provide retrospective reports of continuous glucose information. The reports generated by the CareLink iPro software are intended for use by healthcare professionals to assist with diabetes clinical assessment, patient education, and therapy optimization.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code OZO·October 10, 2017

    TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.

    FDA Recall
    Open, Classified ·Echopixel, Inc.·Product code LLZ·April 11, 2016

    Norian CRS Rotary Mixer Cement 10cc sterile

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code GXP·September 14, 2009

    Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code NKB·March 11, 2011

    02.122.590S, 90mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010