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UNKNOWN KNEE PATELLA

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 1, 2019

Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS

FDA Enforcement
Class II ·Terminated·Medline Industries Inc·September 26, 2018

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 29, 2014

SURESCAN

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 8, 2018

GEL BREAST IMPLANTS

FDA Adverse Event
Injury ·MENTOR WORLDWIDE·Product code FTR·April 24, 2024

GEL BREAST IMPLANTS

FDA Adverse Event
Injury ·MENTOR WORLDWIDE·Product code FTR·April 24, 2024

GEENEN PANCREATIC STENT SET

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 3, 2021

RHINO-LARYNGO VIDEOSCOPE

FDA Adverse Event
Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code EOB·August 16, 2022

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·April 17, 2023

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 10, 2012

SURESCAN

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 6, 2015

SURESCAN

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·March 31, 2021

BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER

FDA Adverse Event
Malfunction ·C.R. BARD INC. (COVINGTON) -1018233·Product code KNX·January 28, 2025

ESSURE

FDA Adverse Event
Injury ·BAYER·Product code HHS·November 23, 2015

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No

FDA Recall
Open, Classified ·Avanos Medical, Inc.·Product code BSY·March 19, 2025

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A

FDA Recall
Open, Classified ·Avanos Medical, Inc.·Product code BSY·March 19, 2025

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A

FDA Recall
Open, Classified ·Avanos Medical, Inc.·Product code BSY·March 19, 2025

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A

FDA Recall
Open, Classified ·Avanos Medical, Inc.·Product code BSY·March 19, 2025

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A

FDA Recall
Open, Classified ·Avanos Medical, Inc.·Product code BSY·March 19, 2025

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A

FDA Recall
Open, Classified ·Avanos Medical, Inc.·Product code BSY·March 19, 2025