BEUDAMED
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    Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FET·August 21, 2024

    Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code FET·June 20, 2016

    Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FET·September 25, 2023

    Olympus JF-160F duodenoscopes (Model NumberJF-160F)

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FET·May 11, 2018

    Olympus JF-140F duodenoscopes (Model NumberJF-140F)

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FET·May 11, 2018

    Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FET·June 30, 2015

    Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FET·June 30, 2015

    Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FET·September 25, 2023

    MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. ET LENGTH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12; b. ET LENGTH DOUBLE SWIVEL, 14 Fr, Item Number/REF: DYNCPDS14; c. ET LENGTH DOUBLE SWIVEL, 16 Fr, Item Number/REF: DYNCPDS16

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code BSY·August 3, 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

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214P; b) ABLATION PACK, Model Number DYNJ82725

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OKV·May 18, 2023

    AFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

    FDA Recall
    Open, Classified ·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·Product code JKA·September 26, 2025

    Bard PEG Safety System ''Guidewire'' Reorder Number: 001928

    FDA Recall
    Terminated ·Bard Endoscopic Technologies·Product code FMF·August 4, 2003

    Bard PEG Safety System ''Guidewire'' Reorder Number: 000930

    FDA Recall
    Terminated ·Bard Endoscopic Technologies·Product code FMF·August 4, 2003

    Bard Ponsky PEG Safety System ''Pull'' Reorder Number: 001925

    FDA Recall
    Terminated ·Bard Endoscopic Technologies·Product code FMF·August 4, 2003

    Bard Ponsky PEG Safety System ''Pull'' Reoder Number: 001927

    FDA Recall
    Terminated ·Bard Endoscopic Technologies·Product code FMF·August 4, 2003

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, Model Number: DYNJ66041A, DYNJ66041B; b. FETAL INTERVENTION PACK, Model Number: DYNJ62319A, DYNJ62319B; c. ULTRASOUND PIV KIT, Model Number: DYNDV2397; d. VAD ACCESS, Model Number: DYNJ24276C; e. VAGINAL DELIVERY TRAY, Model Number: DYNJ27275

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code MLS·May 15, 2023

    Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

    FDA Recall
    Open, Classified ·Koven Technology, Inc.·Product code DPW·March 4, 2026

    Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·December 2, 2019

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    FDA Recall
    Terminated ·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020