SEO landing

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.

Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF

FDA Recall
Terminated ·Arrow International Inc·Product code DQY·April 11, 2018

Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

FDA Recall
Open, Classified ·Genesee BioMedical, Inc.·Product code DWS·February 26, 2018

Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).

FDA Recall
Terminated ·Draeger Medical, Inc.·Product code BSZ·March 1, 2018

LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries.

FDA Recall
Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code LXH·December 22, 2017

BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01

FDA Recall
Terminated ·Datascope Corporation·Product code DWE·October 19, 2017

AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

FDA Recall
Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

FDA Recall
Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

FDA Recall
Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752

FDA Recall
Terminated ·Datascope Corporation·Product code DTN·October 19, 2017

POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362

FDA Recall
Completed ·Bard Peripheral Vascular Inc·Product code LJT·February 8, 2018