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FDA Device Enforcement Reports
View 10000 FDA Device Enforcement Reports on BEUDAMED, the Better Database on Medical Devices. These records compile FDA actions such as recalls, safety alerts, market withdrawals, and warning letters related to medical devices regulated in the United States. Each entry lists device identifiers, manufacturer information, enforcement dates, and the reason for the action to support quick assessment.
FDA Device Enforcement Reports help clinicians, manufacturers, and health-system buyers assess device safety and regulatory status. Use BEUDAMED to monitor trends, compare enforcement activity across device types, and export data for quality and compliance reviews. Regular review of enforcement reports supports post-market surveillance and informed procurement decisions.
CE17TO CONT EPIDURAL SET LF, Material Number 332204 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·October 10, 2018
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·July 1, 2015
Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·July 19, 2017
CNB400TK CONTIPLEX CONT NERVE BLOCK, Material Number 331706 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·October 10, 2018
Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Enforcement
Class I
·Terminated·Stryker Instruments Div. of Stryker Corporation·August 22, 2012
Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
FDA Enforcement
Class II
·Terminated·COVIDIEN LLC·October 10, 2018
NES1727KFX W /17GA TUOHY 19GA SPRW OT, Material Number 333197 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·October 10, 2018
PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·April 18, 2018
Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·January 29, 2014
Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·April 22, 2020