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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.
Angiotech***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - CSR Wrap; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - Towel; 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - 2"x3" ADH Dressing***Catalog Number: BMET1104ATL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
Angiotech***Custom Bone Marrow Tray for University of Chicago*** 2- 20ga x 1 " Safety Needle; 1 21ga x 1-1/2" Safety Needle; 1 25ga x 5/8" Safety Needle; 1 - 10cc Syringe L/L; 2 - 20cc Syringe L/L; 3 - 4" x 4" Sponges in stacks of 5; 2 - 3" x 3" Sponges in stacks of 5; 1 - CSR Wrap; 2 - Fenestrated Drape; 1 - 5" Hemostat Straight Mosquito; 1 - #11 Retractable Scalpel; 1 - 8ga x 4" Bone Marrow Needle "J" Type; 1 - 16ga x 2.688" Bone Marrow Needle "I" Type; 1 - Probe Guide; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - Obturator; 2 - Petri Dish***Catalog Number: CB00541TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 Amber Specimen Bottle w/ Cap; 1 - Specimen Label; 1 - #11 Mini Scalpel; 10 - Micro Slides - Frosted end; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - Stirring Rod; 1 - 2"x3" ADH Dressing; 1 - Towel; 1 - Fenestrated Drape; 1 - CSR Wrap ***Catalog Number: BMT1000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 implantation
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code KWQ·November 30, 2011
syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. This correction applies to customers who use the syngo RT Therapist v4.2 or the combination of syngo RT Therapist v4.2 with syngo RT Oncologist v4.2 from Siemens. 12/7/2011: Update: Syngo RTT4.2.108 SW contains the same SW content when installed on the syngo Oncologist Workspace (license key controlled). Currently the syngo Oncologist SW version is 4.2.92 P04. By installing this update, the Oncologist will match the RTT version 4.2.108. The intended use of the Siemens branded Artiste, Oncor and Primus family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·November 2, 2011
MORPHEUS CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF 1200923, STERILE, AngioDynamics Queensbury, NY 12804 USA --- COMMON/USUAL NAME: Percutaneous, implanted, long-term intravascular catheter; CLASSIFICATION NAME: Percutaneous, implanted, long-term intravascular catheter; Device Listing # D095274. PICC Catheters are utilized for Short or Long Term peripheral access to the Central Venous system for intravenous therapy and power injections of contrast media.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code LJS·December 5, 2011
ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany. ARTISTE, ONCOR and PRIMUS family of linear accelerators deliver X-ray photon and electron radiation for therapeutic treatment of cancer.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·November 9, 2011
HooperHolmes Health & Wellness, Product K8303, each kit packed in an envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Alere Blood Collection Kit (Carolina Care Plan), Product K6900, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug 8-methoxypsoralen (8-MOP) of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestation of cutaneous T-cell lymphoma (CTCL) in person who have not been responsive to other forms of treatment. The Cellex procedural kits are designed to interface with the Cellex Photopheresis System to perform cell separation and photo activation in a single closed and sterile circuit. This is accomplished by use of an integrated centrifuge bowl and associated tubing for separation of whole blood into red blood cells, plasma, and buffy coat (leukocyte-enriched blood). All blood components are returned to the patient. The procedural kits are fully assembled as received by the customer and the customer is only required to place the components in the Cellex System to enable the system for use.
FDA Recall
Terminated
·Therakos, Inc.·Product code LNR·September 1, 2011