51 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
FDA Recall
Open, Classified
·DRG International, Inc.·Product code JLX·September 13, 2024
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
FDA Recall
Open, Classified
·ROi CPS LLC·Product code OHM·March 22, 2023
Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - OH Base Robot Pack ; 5. regard Item Number: 800395003, GS01000C - Colon Lithotomy and 6. regard Item Number: 880391002, GS00995B - Basic Laparotomy.
FDA Recall
Open, Classified
·ROi CPS LLC·Product code LRO·March 22, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code CAI·May 18, 2023
Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B
FDA Recall
Open, Classified
·Product code LRO·May 28, 2026
React Health PHOENIX 5L Oxygen Concentrator
FDA Recall
Open, Classified
·3B Medical, Inc.
5475 Rings Rd Ste 550
Dublin OH 43017-7537·Product code CAW·February 4, 2026
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANESTHESIA CVL KIT-LF, Model Number: DYNJ52283C; b. ANESTHESIA OH TOTE, Model Number: DYNJ61476;
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code CAI·May 15, 2023
Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthroscopy; 5. regard Item Number: 800772006, OR00977F - OH Total Knee Pack ; 6. regard Item Number: 880403004, OR01009D - Extremity Pack; 7. regard Item Number: 880472001, OR01104A - Basic Pack ; 8. regard Item Number: 880470001, OR01102A - Total Knee ; 9. regard Item Number: 800755006, OR00960F - OH Hip Pack ; 10. regard Item Number: 880471001, OR01103A - Shoulder Arthroscopy ; 11. regard Item Number: 880480001, OR01112A - Hand and Foot ; and 12. regard Item Number: 880468001, OR01100A - Spine.
FDA Recall
Open, Classified
·ROi CPS LLC·Product code OJH·March 22, 2023
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·February 21, 2025
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
FDA Recall
Open, Classified
·FujiFilm Healthcare Americas Corporation·Product code IYN·October 14, 2021
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
FDA Recall
Open, Classified
·FujiFilm Healthcare Americas Corporation·Product code IYN·October 14, 2021
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
FDA Recall
Open, Classified
·FujiFilm Healthcare Americas Corporation·Product code IYN·October 14, 2021
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
FDA Recall
Open, Classified
·FujiFilm Healthcare Americas Corporation·Product code IYN·October 14, 2021
Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - Ant/Cervical Spine ; and 5. regard Item Number: 800716005, NU00921E - ORMC Major Crani Pack.
FDA Recall
Open, Classified
·ROi CPS LLC·Product code OJG·March 22, 2023
HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EJG·June 3, 2020
HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EJG·June 3, 2020
HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EJG·June 3, 2020
HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EJG·June 3, 2020
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
FDA Recall
Open, Classified
·Hitachi Healthcare Americas Corporation·Product code IYN·June 30, 2021
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