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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.

Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .

FDA Recall
Terminated ·Exactech, Inc.·Product code JWH·September 19, 2017

smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code JWH·September 14, 2017

NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 20 kits per case.

FDA Recall
Terminated ·Halyard Health, Inc·Product code BSY·October 6, 2017

Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.

FDA Recall
Terminated ·Repro-Med Systems, Inc.·Product code FRN·March 10, 2016

Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.

FDA Recall
Terminated ·Amendia, Inc·Product code OVE·July 7, 2017

Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.

FDA Recall
Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·November 28, 2016

Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.

FDA Recall
Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·November 28, 2016

Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 45-883 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.

FDA Recall
Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·November 28, 2016

Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.

FDA Recall
Terminated ·Medtronic Inc.·Product code NIP·November 3, 2017

Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CHN·May 23, 2017