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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.

PEDIATRIC CRANIOTOME, BM Product Usage: Pneumatic system

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code BWN·October 6, 2016

RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code KDG·March 30, 2017

Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.

FDA Recall
Terminated ·Cook Inc.·Product code FHQ·May 1, 2017

"Pressure Injectable Jugular Axillo-Subclavian Central Catheter (JACC) Product" The CG+ Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central vein. The VPS Stylet, used with the VPS Console, quickly and accurately guides the central catheters to the desired location which is the lower third of the SVC or at the cavo-atrial junction

FDA Recall
Terminated ·Arrow International Inc·Product code FOZ·March 20, 2017

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access

FDA Recall
Terminated ·Arrow International Inc·Product code FOZ·March 20, 2017

Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages

FDA Recall
Terminated ·Cook Inc.·Product code FFS·May 3, 2017

Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.

FDA Recall
Terminated ·Medtest Holdings, Inc.·Product code JJY·May 15, 2014

ARIES System and ARIES M1 System

FDA Recall
Terminated ·Luminex Corporation·Product code OOI·April 19, 2017

Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.

FDA Recall
Terminated ·Mobius Medical Systems, LP·Product code IYE·February 23, 2015

SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic puller. It is a sterile, disposable plastic device designed for single use only.

FDA Recall
Terminated ·Bausch & Lomb Surgical, Inc.·Product code MSS·April 5, 2017