BEUDAMED
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    ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FEB·September 11, 2008

    ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code KOG·February 19, 2010

    Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes. Component: N/A

    FDA Recall
    Open, Classified ·Steris Corporation·Product code FEB·June 13, 2024

    The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.

    FDA Recall
    Terminated ·Custom Ultrasonics, Inc.·Product code NVE·May 6, 2016

    Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.

    FDA Recall
    Terminated ·Market-Tiers Inc·Product code HET·July 16, 2014

    Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054; Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel. Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

    FDA Recall
    Terminated ·Ferring Pharmaceuticals Inc·Product code MOZ·April 16, 2010

    Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.

    FDA Recall
    Open, Classified ·Steris Corporation·Product code FEB·June 13, 2024

    Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.

    FDA Recall
    Open, Classified ·Steris Corporation·Product code FEB·June 13, 2024

    Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.

    FDA Recall
    Open, Classified ·Steris Corporation·Product code FEB·June 13, 2024

    EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FDS·October 31, 2024

    Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION TRAY, REF SUT21580; c) LACERATION TRAY, REF DYNDL1484B;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code PKD·November 15, 2023

    Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DQO·March 3, 2026

    Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DQO·March 3, 2026

    DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope.

    FDA Recall
    Terminated ·Minntech Corp·Product code FEB·June 15, 2010

    Flexible Intubation Fiberscope, Model # 11301AB1

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code EOQ·April 24, 2019

    GE Healthcare OEC 9900 mobile fluoroscopic x-ray system

    FDA Recall
    Terminated ·OEC Medical Systems, Inc·Product code JAA·December 14, 2007

    Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DER·May 16, 2018

    GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code FER·December 12, 2018

    a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219. b. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ2 1" 50YDS Catalog # GL-220. c. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ4 25/8" 50YDS Catalog # GL-222. d. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE WHT W/O APPL 5/8"X50YDS Catalog # GL-241. e. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE WHT W/O APPL 11/2"X50YDS Catalog # GL-243

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code GER·May 25, 2022

    Clinical Chemistry Apolipoprotein A1, List Number 9D92-20

    FDA Recall
    Terminated ·Abbott Laboratories Diagnostic Div·Product code DER·November 10, 2005