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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.

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch. 1 unit per pouch; 50 pouches per case

FDA Recall
Terminated ·ICU Medical Inc·Product code MRZ·July 29, 2019

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 269 cm / 14 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.

FDA Recall
Terminated ·ICU Medical Inc·Product code FRN·July 29, 2019

Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code HHI·September 12, 2019

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case

FDA Recall
Terminated ·ICU Medical Inc·Product code FRN·July 29, 2019

Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

FDA Recall
Terminated ·Ohmeda Medical·Product code FMZ·October 5, 2018

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL40. for cardiovascular use

FDA Recall
Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75, .070", REF SA6AL75. for cardiovascular use

FDA Recall
Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922

FDA Recall
Terminated ·Orthofix Srl Via Delle Nazioni·Product code KTT·September 27, 2018

ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901

FDA Recall
Terminated ·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018

ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791

FDA Recall
Terminated ·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018