All recalls7,877 total
Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Product may contain foreign objects of metal origin.
Product may contain foreign objects of metal origin.
Product may contain foreign objects of metal origin.
Cucumbers have the potential to be contaminated with Salmonella
Label declares Shelled Edamame but does not specify or declare soy.
Undeclared Peanuts. The firm was notified by their supplier, that the product may contain undeclared peanuts.
Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine lot by lot testing was completed properly however the quarterly dose audit (sampling/testing to monitor the gamma sterilization process and confirm the validated parameters remain effective to assure sterility and bioburden reduction per requirements) was not completed on time.
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Due to defects (bubbles/voids) identified during standard finished goods testing
Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Contains undeclared peanut
Potential contamination with floating objects
Potential contamination with floating objects
Potential contamination with floating objects
Potential contamination with floating objects
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.