💊 Drugs Class I - Dangerous
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
All Recalls
95,018 total recalls in our database
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
💊 Drugs Class I - Dangerous
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Aspen Surgical Products
🏥 Medical Devices Class I - Dangerous
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
🏥 Medical Devices Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter Data was manipulated to appear to be conforming
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
🏥 Medical Devices Class I - Dangerous
Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment
🏥 Medical Devices Class I - Dangerous
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
🏥 Medical Devices Class I - Dangerous
Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
🏥 Medical Devices Class I - Dangerous
Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Thera Test Laboratories
🏥 Medical Devices Class I - Dangerous
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Thera Test Laboratories
🏥 Medical Devices Class I - Dangerous
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Merge Healthcare
🏥 Medical Devices Class I - Dangerous
The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.