BEUDAMED
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    Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: No

    FDA Recall
    Open, Classified ·THOR Photomedicine Ltd 2 Anglo Office Park Units 1 &; 67 White Lion Road Amersham United Kingdom·Product code ILY·July 24, 2025

    Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: N/A

    FDA Recall
    Open, Classified ·THOR Photomedicine Ltd 2 Anglo Office Park Units 1 &; 67 White Lion Road Amersham United Kingdom·Product code ILY·July 24, 2025

    Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: N/A

    FDA Recall
    Open, Classified ·THOR Photomedicine Ltd 2 Anglo Office Park Units 1 &; 67 White Lion Road Amersham United Kingdom·Product code ILY·July 24, 2025

    Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: No

    FDA Recall
    Open, Classified ·THOR Photomedicine Ltd 2 Anglo Office Park Units 1 &; 67 White Lion Road Amersham United Kingdom·Product code ILY·July 24, 2025

    HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code FGE·October 21, 2021

    Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile; (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile; (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile; (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile; (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile; (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile; (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile; (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile; (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile; (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile; (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile; (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile.

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

    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree

    FDA Recall
    Open, Classified ·Wilson-Cook Medical Inc.·Product code FGE·November 3, 2023

    EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FGE·November 10, 2023

    Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GPN:G09767

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code FGE·May 15, 2024

    SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Recall
    Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

    Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code FGE·July 29, 2022

    Freeman Pancreatic Flexi-Stent Catalog Number: 6535

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code FGE·July 29, 2022

    LAPAROSCOPY PACK , Model No SFLA02A SFLA02B

    FDA Recall
    Open, Classified ·American Contract Systems Inc·Product code FDE·February 6, 2025

    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree

    FDA Recall
    Open, Classified ·Wilson-Cook Medical Inc.·Product code FGE·November 3, 2023

    Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code FGE·March 1, 2024

    American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code FDE·May 6, 2024

    Refer to RES

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FDE·March 3, 2025

    Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K; 3) LAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J; 4) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N; 5) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763O; 6) BWNBORO LAP CHOLE PACK-LF, Kit SKU DYNJ32836B; 7) MINOR SET UP PACK, Kit SKU DYNJ43272K; 8) PK, GEN LAPAROSCOPIC CHOLE, Kit SKU DYNJ43976C; 9) GV LAP CHOLE PACK, Kit SKU DYNJ46939Q; 10) LAP CHOLE PACK, Kit SKU DYNJ49688C; 11) GENERAL ROBOTIC LAP, Kit SKU DYNJ51347N; 12) LAP CHOLE PACK, Kit SKU DYNJ54081F; 13) PEDIATRIC MOSES, Kit SKU DYNJ58864B; 14) LAPAROTOMY PACK, Kit SKU DYNJ59313B; 15) CRMC LAP CHOLE DIAG LAP-LF, Kit SKU DYNJ61095F; 16) LAP GASTRIC PACK, Kit SKU DYNJ62065A; 17) MINOR PACK, Kit SKU DYNJ64174A; 18) GENERAL SURGERY PACK, Kit SKU DYNJ64258I; 19) GENERAL LAP SHARED-LF, Kit SKU DYNJ64786D; 20) CHOLE PACK, Kit SKU DYNJ67686B; 21) GEN SURG MINOR PACK, Kit SKU DYNJ69142F; 22) LAP CHOLE PACK, Kit SKU DYNJ81695B; 23) GENERAL LAPAROSCOPY, Kit SKU DYNJ900901K; 24) GEN MINOR, Kit SKU DYNJ900906L; 25) ROBOTIC GENERAL, Kit SKU DYNJ906861D; 26) RMC GENERAL LAPAROSCOPIC, Kit SKU DYNJ907087C; 27) LAP CHOLE LMC CDS, Kit SKU DYNJ911116A; 28) MINOR GENERAL PACK, Kit SKU DYNJT3884; 29) GENERAL LAPAROSCOPY PACK, Kit SKU DYNJT4504; 30) MINOR SURGERY PACK-LF, Kit SKU PHS109062D.

    FDA Recall
    Open, Classified ·Product code FDE·December 12, 2025

    SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Recall
    Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

    ACS Lap Chole Pack

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code FDE·March 22, 2022