SEO landing

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.

Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark

FDA Enforcement
Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal differences between the functionality of the two models, each of which function as a highly complex system of a large number of individual components.

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·January 8, 2014

Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.

FDA Enforcement
Class II ·Terminated·Leica Microsystems, Inc.·October 10, 2018

PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881

FDA Enforcement
Class II ·Terminated·Ethicon, Inc.·July 25, 2018

BULK NONSTERILE PERIFIX CATHETER CONN., Material Number 8451699N 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

Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·November 21, 2018

EPID. CATH. NG, 20GA. CLOSED TIP-LF, Material Number 333541 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

DESIGN OPTIONS¿ PAIN MANAGEMENT TRAY, Material Numbers 530029, 530029, 530031, 530035, 530041, 530048, 530068, 530071, 530083, 530108, 530112, 530122, 530123, 530124, 530132, 530133, 530134, 530138, 530141, 530142, 530149, 530153, 530155, 530159, 530160, 530164, 530168, 530169, 530171, 530175, 530177, 530179, 530180, 551028, 551266, 551342, 551344, 551394, 551411, 551437, 551474, 551554, 551572, 551624, 551630, 551671, 551672, 551714, 551731, 551732, 551749, 551769, 551771, 551773, 551791, 551810, 551816, 551849, 551859, 551875, 551879, 551889, 551920, 551922, 551938, 551942, 551951, 551971, 551994, 551997, 551998, 552006, 552011, 552020, 552021, 552030, 552031, 552038, 552041, 552047, 552048, 552051, 552076, 552077, 552079, 552083, 552089, 552099, 552100, 552101, 552112, 552113, 552116, 552117, 552119, 552121, 552122, 552123, 552125, 552126, 552133, 552135, 552136, 552147, 552149, 555030, 555040, 555051, 555061, 555063, 555067, 555070, 555076, 555079, 555083, 555091, 555098, 555100, 555110, 555170, 555172, 555175, 555202, 555204, 555215, 555217, 555259, 555271, 555277, 555290, 555296, 555299, 555325, 555340, 555357, 555374, 555421, 555422, 555438, 555449, 555450, 555482, 555483, 555484, 555498, 555525, 555551, 555569, 555578, 555579, 555601, 555647, 555660, 555704, 555706, 555757, 555779, 555854, 555857, 555884, 555904, 555931, 555951, 555987, 570180, 570205, 570222, 570234, 570245, 570246, 570269, 570285 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

Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

FDA Enforcement
Class II ·Ongoing·Respironics California, LLC·February 3, 2021

CONTIPLEX CONT 4 IN TUOHY ULTRA PNB TRAY, Material Number 332129 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