Xstrahl Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy recall — FDA Z-0389-2022
Base plate may detach from the main body of the treatment applicator.
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Base plate may detach from the main body of the treatment applicator.
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released…
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could…
Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.
Potential for open packaging seals compromising the sterility of the surgical gowns
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released…
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system…
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its…
Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can…
Probiotic products contaminated with Pseudomonas aeruginosa .
Complaint led investigation found the presence of Bacillus Cereus in one lot of product.
Product labeled to contain iodized salt actually contain salt not fortified with iodine.
Probiotic products contaminated with Pseudomonas aeruginosa .
Wrong Product in packaging - Simply Peppered Mustard bottles were filled with Simply Horsey Mustard
The firm was notified by customers that the product contained metal fragments
potential for glass and metal in product
Probiotic products contaminated with Pseudomonas aeruginosa .
Defective container: Out of specification for container integrity leading to bottles leaking.
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Tesla, Inc. (Tesla) is recalling certain 2014-2021 Model S vehicles. The front trunk latch assembly may be misaligned, preventing the secondary hood latch from engaging. As such, these…
Browse recent months with enough recall history for useful comparison.