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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.

3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573

FDA Recall
Terminated ·Becton Dickinson & Company·Product code FMF·February 1, 2019

AXIOM Artis BC, Model Number 5904649

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019

Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.

FDA Recall
Terminated ·InfuTronix LLC·Product code FRN·May 28, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM

FDA Recall
Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP

FDA Recall
Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tracheal tube/airway management

FDA Recall
Terminated ·Teleflex Medical·Product code BTR·May 24, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP

FDA Recall
Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF

FDA Recall
Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10

FDA Recall
Terminated ·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019

Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature.

FDA Recall
Terminated ·Cook Inc.·Product code PNO·May 24, 2019