Complete FDA and NHTSA recall records dated in April 2025.
These records include useful source details for the selected month.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or…
The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of…
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a…
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder…
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use…
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood…
Potential contamination with patulin.
Potential contamination with foreign objects.
The recall is being carried out because repacking methods pose a possible risk of contamination. Sealing methods are not heat-sealed.
Glass fragments found in finished product.
The recall is being carried out because repacking methods pose a possible risk of contamination. Sealing methods are not heat-sealed.
Potential contamination with foreign objects.
Undeclared Milk - During an FDA inspection the firm was notified that milk was not declared on the label.
Product does not declare the allergen, milk, on the label.
The recall is being carried out because repacking methods pose a possible risk of contamination. Sealing methods are not heat-sealed.
Undeclared allergen: Wheat
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability…
Lack of Assurance of Sterility: Leaking/damaged syringes.
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
