11 results
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12ms
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Sources: EU EUDAMED, US FDA
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2
FDA Recall
Open, Classified
·CooperSurgical, Inc.·Product code HEW·April 23, 2021
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
FDA Recall
Open, Classified
·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
FDA Recall
Open, Classified
·KCI USA, INC.·Product code OMP·November 5, 2024
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, US PRE4001AU PREVENA PLUS SYSTEM KIT, AU PRE4001CA PREVENA PLUS SYSTEM KIT, CA PRE4001UK PREVENA PLUS SYSTEM KIT, UK PRE4001US PREVENA PLUS SYSTEM KIT, US PRE4001 PREVENA PLUS SYSTEM KIT PRE4001ZA PREVENA PLUS SYSTEM KIT, ZA PRE4010 PREVENA PLUS STANDALONE EXTENDED LIFE SYSTEM KIT PRE5001 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 33X30 CM PRE5101 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 46X30 CM PRE5221 PREVENA RESTOR BELLA-FORM SYSTEM KIT 21X19 CM PRE5321 PREVENA RESTOR BELLA-FORM SYSTEM KIT 24X22 CM PRE5421 PREVENA RESTOR BELLA-FORM SYSTEM KIT 29X27 CM PRE5501 PREVENA RESTOR AXIO-FORM SYSTEM KIT 29X28 CM
FDA Recall
Open, Classified
·KCI USA, INC.·Product code QFC·January 17, 2025
3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper
FDA Recall
Open, Classified
·KCI USA, INC.·Product code OMP·January 17, 2025
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GCP·November 11, 2025
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GCP·September 13, 2024
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GCP·September 13, 2024
PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493
FDA Recall
Open, Classified
·CP Medical Inc·Product code GAM·February 2, 2017
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
FDA Recall
Open, Classified
·CP Medical Inc·Product code GAM·October 18, 2019
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.
FDA Recall
Open, Classified
·CP Medical Inc·Product code GAL·February 4, 2019