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Sources: EU EUDAMED, US FDA
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Cardiovascular Custom Procedure Kits, REV: 2A, REV: 2B X-COATED FX PK Item Number: 73191 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011
ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
FDA Recall
Terminated
·Conmed Corporation·Product code GCJ·March 21, 2019
ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
FDA Recall
Terminated
·Conmed Corporation·Product code GCJ·March 21, 2019
ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
FDA Recall
Terminated
·Conmed Corporation·Product code GCJ·March 21, 2019
a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AG2X2" (10/BX 10BX/CS) Catalog #3557. c. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGSHEET 4"X4.75" (10/BX) Catalog #3558. d. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGSHEET 4"X8" (5/BX 10 Catalog #3559. e. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGROPE 3/4"X12" (5/BX 10BX/CS) Catalog #3560. f. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 2"X2" (10/BX 10BX/C Catalog #3561. g. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X4.75" (10/BX 1 Catalog #3562. h. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS) Catalog #3563. i. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE ROPE 3/4"X12" (5/BX 10BX/CS) Catalog #3564. j. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, SKIN FOLD MGMNT AG 10"X144" (1/BX 12BX/CS) Catalog #16-10144R
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
ABX Diagnostices Pentra 60C+ Hematology Analyzer
FDA Recall
Terminated
·ABX Diagnostics Inc·Product code GKZ·June 4, 2003
Automated Differential Cell Counter
FDA Recall
Terminated
·ABX Diagnostics Inc·Product code GKZ·August 13, 2004
PENTRA 120 and PENTRA 120 Retic Hematology Analyzer
FDA Recall
Terminated
·ABX Diagnostics Inc·Product code GJH·June 24, 2004
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Recall
Open, Classified
·Max Mobility LLC·Product code ITI·August 12, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Recall
Open, Classified
·Max Mobility LLC·Product code ITI·August 12, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Recall
Open, Classified
·Max Mobility LLC·Product code ITI·December 20, 2024
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Recall
Open, Classified
·Max Mobility LLC·Product code ITI·December 20, 2024
Pentra 80 and Pentra 80XL Hematology Analyzers
FDA Recall
Terminated
·ABX Diagnostics Inc·Product code GKZ·April 8, 2004
ABX Pentra 120,120R,120DX, automated hematology analyzer
FDA Recall
Terminated
·ABX Diagnostics Inc·Product code GKZ·March 24, 2006
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Recall
Open, Classified
·Max Mobility LLC·Product code ITI·August 12, 2025
Automated Differential Cell Counter
FDA Recall
Terminated
·ABX Diagnostics Inc·Product code GKZ·August 13, 2004
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)
FDA Recall
Open, Classified
·MedicalCommunications GmbH Max-Jarecki-Str. 8 Heidelberg Germany·Product code NFJ·September 9, 2025
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
FDA Recall
Open, Classified
·Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany·Product code MZO·March 4, 2024
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
FDA Recall
Open, Classified
·Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany·Product code MZO·March 4, 2024
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code GBX·December 14, 2022