All Recalls

95,075 total recalls in our database

Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.

Apr 11, 2018 Infusion Pumps Nationwide View Details →

The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.

May 24, 2018 Diagnostic Equipment Nationwide View Details →

The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.

May 16, 2018 Implants & Prosthetics Nationwide View Details →

Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. (b) Biograph mCT S(40)-4R, Material Number 10248671 (c) Biograph mCT S(64)-4R, Material Number 10248672 (d) Biograph mCT X-4R, Material Number 10248670 (e) Biograph mCT X-3R, Material Number 10248673 (f) BIOGRAPH mCT 20 Excel, Material Number 10507786 (g) Biograph mCT Flow Edge-4R, Material Number 10528955 (h) Biograph mCT S(40)-3R, Material Number 10248668 (i) Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 (j) Biograph mCT Flow 40-4R, Material Number 10529159 (k) Biograph mCT-X w/TrueV Upgrade, Material Number 10250745

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biograph mCT and Biograph mCT Flow systems.

May 29, 2018 Diagnostic Equipment View Details →

The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.

May 16, 2018 Implants & Prosthetics Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects (Model 106 only); " No stimulation in the case of device disablement (Burst Watchdog Timeout), resulting in no therapy to the patient (Model 106 only); " Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved within device specification (Models 103, 104, 105, or 106); and/or " Delays or absence of the 75% and 50% battery life indicators displayed by the programming software (Models 103, 104, 105, or 106).

Nov 13, 2017 Other Medical Devices Nationwide View Details →

Olympus JF-160F duodenoscopes (Model NumberJF-160F)

Olympus Corporation of the Americas

🏥 Medical Devices Class I - Dangerous

Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.

May 11, 2018 Other Medical Devices Nationwide View Details →

Stanley workbench LED light and power stations

Hairishen Electric (Shenzhen) Co. Ltd., of China

🏠 Consumer Products Class I - Dangerous

The recalled workbench and power stations are wired incorrectly, which can result in reverse polarity, posing shock and electrocution hazards.

Jun 26, 2018 Furniture Nationwide View Details →