ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
All Recalls
95,018 total recalls in our database
LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx
First Royal Care Co. LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
🏥 Medical Devices Class I - Dangerous
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
🏥 Medical Devices Class I - Dangerous
Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue encapsulation and bag closure more difficult, introducing the risk of trapping the small bowel/viscera in the bag at closure resulting in patient injury.
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
Two devices were labeled with the same serial number
Bivona Aire-Cuf Endotracheal Tube
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
🏥 Medical Devices Class I - Dangerous
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
Holes in product packaging impacts package integrity and may compromise sterility.
RAPTAR Laser Range Finders
Potomac River Group
🏥 Medical Devices Class I - Dangerous
RAPTAR units are capable of being field modified to enable the use of the higher power visible and IR laser pointers and the IR Illuminator.
C315-HIS Delivery Catheter
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
🏥 Medical Devices Class I - Dangerous
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018
W L Gore & Associates
🏥 Medical Devices Class I - Dangerous
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
🏥 Medical Devices Class I - Dangerous
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
🏥 Medical Devices Class I - Dangerous
The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. This may lead to the user making incorrect conclusions using incorrect results.
🏥 Medical Devices Class I - Dangerous
The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.
🏥 Medical Devices Class I - Dangerous
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
🏥 Medical Devices Class I - Dangerous
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.