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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.

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 9 Fr. Introducer Kit Ref Product No. AP-06013.

FDA Recall
Terminated ·Arrow International Inc·Product code LJT·September 29, 2006

LIFEPAK 20 automatic external defibrillator

FDA Recall
Terminated ·Medtronic Emergency Response Systems, Inc.·Product code LDD·March 16, 2006

Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N

FDA Recall
Terminated ·Atrium Medical Corporation·Product code CAC·November 8, 2006

Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-08-0300 Vbeam Perfecta w/ gray enclosure and gray colored display

FDA Recall
Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·October 16, 2006

LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent to customers in the following configurations: 1) The plate is purchased in sets of 5 as part number E8800BG 8 Channel Breast Biopsy Lateral Grids (pack of 5 grids) or 2) the plate is purchased in pairs with the following part numbers: M3087JG, which contains Liberty 9000 8-Channel Breast Coil, 2 plates and a manual; G3087JH, which contains 2 plates and a manual; M3335LA, which contains a 3T HD 8 channel Vibrant Breast Array, 2 plates and a manual.

FDA Recall
Terminated ·USA Instruments Incorporated·Product code LNH·November 21, 2006

Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, containing 1/20-gauge high speed vitrectomy cutter as well as other accessories. Catalog #USSCX4920A is also included in the recall, which is used by customers for ordering only . There is no labeling associated with this catalog number. This catalog number is used for ordering Cat. #4920 along with Cat. #MVS1011C-20g, Light Pipe (which is not under recall). These two products are packaged separately and are not bundled in any way. They are merely shipped at the same time. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.

FDA Recall
Terminated ·Bausch & Lomb Inc·Product code HQE·December 14, 2006

Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD

FDA Recall
Terminated ·Puritan Bennett Corporation·Product code MNT·August 31, 2006

Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2M8161R

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·December 6, 2006

REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265

FDA Recall
Terminated ·Respironics, Inc.·Product code BTT·October 25, 2006