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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.

MiniMed Paradigm Insulin pump, model number MMT-712

FDA Recall
Open, Classified ·Medtronic MiniMed·Product code LZG·June 27, 2019

Medtronic MiniMed Paradigm Insulin pump, model number MMT-522

FDA Recall
Open, Classified ·Medtronic MiniMed·Product code OYC·June 27, 2019

Medtronic MiniMed Paradigm Insulin pump, model number MMT-723

FDA Recall
Open, Classified ·Medtronic MiniMed·Product code OYC·June 27, 2019

ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

FDA Recall
Terminated ·Northgate Technologies, Inc.·Product code FFK·March 10, 2020

Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

FDA Recall
Open, Classified ·Skytron, Div. The KMW Group, Inc·Product code FQO·March 5, 2020

MiniMed Paradigm 512 Insulin pump

FDA Recall
Open, Classified ·Medtronic MiniMed·Product code LZG·June 27, 2019

BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

FDA Recall
Terminated ·Bard Peripheral Vascular Inc·Product code LJT·October 1, 2019

Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643

FDA Recall
Terminated ·Cook Inc.·Product code GBX·March 6, 2020

MiniMed Insulin Pump, model # MMT-508

FDA Recall
Open, Classified ·Medtronic MiniMed·Product code LZG·June 27, 2019

Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

FDA Recall
Terminated ·Capintec Inc·Product code IZD·March 3, 2020