764 results
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23ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
FDA Recall
Open, Classified
·Custom Medical Specialties, Inc.·Product code FCH·September 20, 2016
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC·Product code LRO·April 28, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC·Product code LRO·November 24, 2025
Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators
FDA Recall
Open, Classified
·3B Medical, Inc.
203 Avenue A Nw Ste 300
Winter Haven FL 33881-4540·Product code BZB·November 27, 2024
Design Options Spinal Tray Material Description (Material Number): SSK HACKENSACK MEDICAL CTR 20061890 (560074), SSK SUTTER COMMUNITY HOSPITAL (560214), SSK BJC HEALTH SYSTEMS (ORIGINAL CUST) (560272), SSK CA PACIFIC MED. CTR (ORIGINAL CUST) (560327), SSK TORRANCE MEMORIAL HOSPITAL (560394), SSK SURGERY ONE 20070208 (560428), SSK LUTHERN GENERAL HOSP (ORIGINAL CUST) (560462), SSK HOAG MEMORIAL HOSPITAL (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK KAISER FOUNDATION HOSPITAL (560497), SSK THOMAS JEFFERSON UNIV HOSP (560513), SSK OVERLAKE MEDICAL CENTER (560521), SSK CUSTOM SPINAL TRAY (560523), SSK ORLANDO REGIONAL MED CENTER (560533), SSK BON SECOURS HEALTH SYS 20115122 (560538), SSK MANATEE MEMORIAL (560572), SSK MOUNT SINAI 27GA PENCAN SPINAL TRAY (560580), SSK SHANDS TEACHING HOSP. & CLINICS, INC (560584), SSK UNIVERSITY OF COLORADO (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK MAYO CLINIC - BUPIVACAINE TRAY (560609), SSK THE MEDICAL CENTER (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK EMORY ORTHO & SPINE HOSPITAL-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK MAYO CLINIC OB DEPT - SPINAL (560645), SSK BAPTIST HOSPITAL OF MIAMI (560646), SSK MERCY GILBERT MEDICAL CENTER (560647), SSK ST.MARY'S HOSPITAL (560648), SSK HARRIS HEALTH SYSTEM (560660), OHIO STATE U MEDICAL CTR SPINAL TRAY SSK (560667), ALBANY MEDICAL CENTER, SSK (560670), STONY BROOK HOSPITAL - SPINAL TRAY SSK (560672);
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code OFU·May 6, 2026
SQ40S Blood Transfusion Filter
FDA Recall
Open, Classified
·GVS TM, Inc·Product code CAK·November 3, 2025
Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
FDA Recall
Open, Classified
·Orthoscan, Inc.·Product code OWB·August 8, 2024
Ziehm Solo. Digital Mobile C-arm
FDA Recall
Open, Classified
·Orthoscan, Inc.·Product code OWB·August 8, 2024
Ziehm Solo FD. Interventional fluoroscopic x-ray system
FDA Recall
Open, Classified
·Orthoscan, Inc.·Product code OWB·August 8, 2024
Ziehm Vision R. Iterventional fluoroscopic x-ray system
FDA Recall
Open, Classified
·Orthoscan, Inc.·Product code OWB·August 8, 2024
Ziehm Vision FD. Interventional fluoroscopic x-ray system
FDA Recall
Open, Classified
·Orthoscan, Inc.·Product code OWB·August 8, 2024
Ziehm Vision system, x-ray, tomography, computed.
FDA Recall
Open, Classified
·Orthoscan, Inc.·Product code JAK·August 8, 2024
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
FDA Recall
Open, Classified
·Orthoscan, Inc.·Product code OWB·August 8, 2024
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
FDA Recall
Open, Classified
·Applied Medical Technology Inc·Product code PIF·November 26, 2024
Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/2"X5YDSSTR LF (12/CS) MGM61 Catalog #61-59220. c. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1"X5YDS STR LF (12/CS) MGM61 Catalog #61-59320. d. DERMA SCIENCES, INC. MediHoney DRESSING, MEDIHONEY GEL STR TU0.5OZ (10/BX 4BX/CS) MGM61 Catalog #DUP31805. e. DERMA SCIENCES, INC DuPad PAD, ABD STR 8X10 (25/BX 8BX/CS) Catalog #DUP87810. f. DERMA SCIENCES, INC Shur-Conform Oil Emulsion non-adhering DRESSING, OIL EMULSION 3"X3"23251-210 DERSCI Catalog #DKC77041
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code FRO·May 25, 2022
Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
FDA Recall
Open, Classified
·Oakworks Inc·Product code LGX·December 5, 2023
Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
FDA Recall
Open, Classified
·Oakworks Inc·Product code LGX·December 5, 2023
Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table
FDA Recall
Open, Classified
·Oakworks Inc·Product code LGX·December 5, 2023
Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}
FDA Recall
Open, Classified
·Oakworks Inc·Product code LGX·December 5, 2023
Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
FDA Recall
Open, Classified
·Ortho Kinematics, Inc·Product code LLZ·August 12, 2016