22 results · 20ms · Sources: EU EUDAMED, US FDA

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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

Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910

FDA Recall
Open, Classified ·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023

Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324

FDA Recall
Open, Classified ·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023

Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908

FDA Recall
Open, Classified ·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;

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

Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;

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

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;

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

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;

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

Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21. Model Number: CHAIR-0-SC2-030; Advance Chair, 100mm (4in) Castors, Std Backrest, Electric; Serial Numbers: 10001-SC2-20 to 10135-SC2-20; 10001-SC2-21 to 10240-SC2-21. Model Number: CHAIR-0-SC3-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Manual; Serial Numbers: 10116-SC3-20 to 10145-SC3-20; 10236-SC3-20 to 10295-SC3-20; 10001-SC3-21 to 10090-SC3-21; 10271-SC3-21 to 10360-SC3-21; 10001-SC3-20 to 10115-SC3-20; 10146-SC3-20 to 10235-SC3-20. Model Number: CHAIR-0-SC4-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Electric; Serial Numbers: 10001-SC4-20 to 10030-SC4-20.

FDA Recall
Open, Classified ·Accora Inc·Product code INM·June 21, 2021

Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network License C10577 - Kaluza C 5 User Network License C10578 - Kaluza C Single Perpetual Educational License C10579 - Kaluza C Single User 1-year Educational License C10580 - Kaluza C 10 User Network Educational License C10581 - Kaluza C 5 User Network Educational License and C21166 - Kaluza C Program DVD v1.0

FDA Recall
Open, Classified ·Beckman Coulter, Inc.·Product code JQP·June 23, 2021

BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JQP·October 31, 2024

BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JQP·October 31, 2024

BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JQP·October 31, 2024

cobas infinity central lab, Material Number 07154003001

FDA Recall
Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JQP·December 12, 2022

BD Synapsys Informatics Solution, Catalog Number 444150

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JQP·June 8, 2023

MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.

FDA Recall
Open, Classified ·Medical Information Technology, Inc.·Product code JQP·February 5, 2025

BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JQP·September 12, 2024

BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JQP·October 31, 2024

AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255

FDA Recall
Open, Classified ·Beckman Coulter Inc.·Product code JQP·November 9, 2018

BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JQP·September 23, 2025