BEUDAMED
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    Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code OCC·October 10, 2019

    Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code JTW·January 27, 2022

    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

    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

    BostonSight SCLERAL Lens

    FDA Recall
    Open, Classified ·Boston Foundation For Sight·Product code HQD·June 10, 2025

    BostonSight PROSE Lens.

    FDA Recall
    Open, Classified ·Boston Foundation For Sight·Product code HQD·June 10, 2025

    11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code EOQ·April 1, 2022

    11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FAJ·April 1, 2022

    11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FBO·April 1, 2022

    CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FBO·April 1, 2022

    11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code EOB·April 1, 2022

    11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FBO·April 1, 2022

    11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018);

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FGB·April 1, 2022

    11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FBO·April 1, 2022

    Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code ITX·March 18, 2022

    11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FGB·April 1, 2022