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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.

SKYLight, AZ 8 FT 3/8"; 8 FT, 5/8"; 9 FT 3/8"; and 9 FT 5/8". Philips Medical Systems Intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

FDA Recall
Terminated ·Philips Medical Systems·Product code KPS·December 28, 2010

XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #: 1161928

FDA Recall
Terminated ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTM·January 7, 2011

Cylindrical Bullet Nose Reamer 8.0 mm x 250 mm, REF 475804, Biomet Orthopedics 66 East Bell Drive Warsaw IN. The product is used to prepare the femoral canal for stem implantation.

FDA Recall
Terminated ·Biomet, Inc.·Product code HTO·December 23, 2010

Applied Medical's LAP CHOLE KIT 7 GK; Model Number: GK107 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010

Applied Medical's LAP CHOLE ; Model Number: K2155 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010

CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analyzer, List Number 07H95-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA Medical device component. The CELL-DYN 4000 System is a multiparameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The vent head spring assembly is used in the auto-sampling mechanism on the CELL-DYN 4000.

FDA Recall
Terminated ·Abbott Laboratories·Product code GKZ·December 29, 2009

CA19-9 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

FDA Recall
Terminated ·BioCheck Inc·Product code NIG·December 22, 2010

PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 15 hole, Sterile, REF 8141-30-115, Depuy Orthopaedics, Inc., Warsaw, IN.

FDA Recall
Terminated ·Depuy Orthopaedics, Inc.·Product code HRS·November 1, 2010

Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.

FDA Recall
Terminated ·Remington Medical Inc.·Product code KNW·February 7, 2011

Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

FDA Recall
Terminated ·Maquet Cardiovascular, LLC·Product code DSY·December 7, 2010