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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.

Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants

FDA Recall
Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

Certain Temporary Hexed Cylinder Dental implants

FDA Recall
Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.

FDA Recall
Terminated ·Zimmer Biomet Spine, Inc·Product code MAX·June 30, 2016

Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.

FDA Recall
Terminated ·C.R. Bard, Inc.·Product code DWJ·June 30, 2016

Zimmer Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

FDA Recall
Terminated ·Zimmer Surgical Inc·Product code GFD·July 4, 2016

Zimmer Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

FDA Recall
Terminated ·Zimmer Surgical Inc·Product code GFD·July 4, 2016

STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).

FDA Recall
Terminated ·Intuitive Surgical, Inc.·Product code NAY·July 14, 2016

MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 20, 2016

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Recall
Terminated ·CHG Hospital Beds Inc 153 Towerline Place London Canada·Product code FNL·June 28, 2016

G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code HBE·August 26, 2016