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FDA Medical Device Recalls

View 10000 FDA Medical Device Recalls on BEUDAMED, the Better Database on Medical Devices. This searchable listing aggregates recall notices issued by the U.S. Food and Drug Administration for devices removed, corrected, or returned due to safety, labeling, or performance concerns. Each record summarizes the recall reason, affected models and lots, recall class, and recommended actions for patients and providers.

Searchable filters help stakeholders identify affected manufacturers, device models, and recall classes (Class I–III) and review timelines and remediation steps. Healthcare providers and purchasers can use these records to verify whether inventory is affected and to implement recommended corrections, returns, or patient notifications.

Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYNDA2863H; c) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518; d) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518H; e) KIT ULTRASOUND PIV START, REF DYNDV2445; f) NICU INSERTION & DRSG CHG TRAY, REF EBSI1306A; g) PIV BSI KIT, REF BSIPIV1010; h) ULTRASOUND GUIDED IV START KIT, REF DYNDV2465

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code LRS·November 15, 2023

AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017

FDA Recall
Open, Classified ·Vyaire Medical·Product code BTM·January 10, 2024

The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.

FDA Recall
Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·November 15, 2023

HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)

FDA Recall
Open, Classified ·AMD Medicom Inc. 2555 Ch de L'Aviation Montreal Canada·Product code FXX·December 21, 2023

Baxter Exactamix Pro 1200, REF EXM12DY

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code LHI·December 22, 2023

EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic

FDA Recall
Open, Classified ·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code MOB·May 24, 2023

Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U

FDA Recall
Open, Classified ·American Contract Systems, Inc.·Product code OJF·November 29, 2023

bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·November 30, 2023

iQ Waste Well Adapter, Part Number: 700-3393

FDA Recall
Open, Classified ·Beckman Coulter, Inc.·Product code LKM·December 19, 2023

Bard PreVent Anti-Reflux Filter with ENFit, REF EN0046000

FDA Recall
Open, Classified ·C.R. Bard Inc·Product code FEG·December 20, 2023