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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.

DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03

FDA Recall
Terminated ·Valeritas, Incorporated·Product code LZG·July 3, 2019

Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box includes 50 eaches of liners in a poly bag and the second box includes 50 eaches of lids in a poly bag. For OR530H, the customer receives the number of liners and lids purchased in one case without the individual boxes. The "H" denotes a single quantity when being ordered.

FDA Recall
Open, Classified ·Medline Industries Inc·Product code KDQ·January 31, 2019

C3 Wave App, v. 2.0.5

FDA Recall
Terminated ·Medical Components, Inc dba MedComp·Product code LJS·October 1, 2018

IV START KIT IV8440

FDA Recall
Terminated ·Centurion Medical Products Corporation·Product code LRS·April 24, 2019

BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JKA·May 13, 2019

Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry

FDA Recall
Terminated ·MicroAire Surgical Instruments, LLC·Product code GET·March 11, 2016

American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

FDA Recall
Terminated ·American Surgical Company·Product code HBA·March 31, 2016

Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multiple component.

FDA Recall
Terminated ·Biomet, Inc.·Product code KTT·April 1, 2016

American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges

FDA Recall
Terminated ·American Surgical Company·Product code HBA·March 31, 2016

American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product Usage: Neurosurgical and Nonneurosurgical Sponges

FDA Recall
Terminated ·American Surgical Company·Product code GDY·March 31, 2016