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This category has a significant number of recalls. Check it regularly if you own products in this area.
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Labeling: Incorrect or Missing Lot and/or Exp Date
Marketed Without an Approved NDA/ANDA
Labeling: Incorrect or Missing Lot and/or Exp Date
The impacted lot may not meet the required tensile strength specification.
Lack of Assurance of Sterility:
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
This recall involves Almpal dissolved oxygen test kits. The test kits come in a cream-colored box bearing a white label with "Dissolved Oxygen Test Kit" and the manufacture date, batch number, and expiration date printed on it.
ICU Medical recalls 23,203 IV gravity burette sets worldwide. The burette component is missing an internal shutoff valve, which can delay therapy, cause overdelivery, or allow air to be infused. Stop using the device and contact ICU Medical for instructions.
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Presence of Particulate Matter: Particulate matter identified as glass
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)
The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
Medline Industries recalled 222,800 alcohol prep pads nationwide on Sept. 29, 2025 due to subpotent potency. The pads are 2-ply, 70% isopropyl alcohol. Stop using immediately and contact Medline or your healthcare provider for guidance.
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.