Complete FDA and NHTSA recall records dated in July 2025.
These records include useful source details for the selected month.
Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7…
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels…
Certain Spectrum infusion pumps may have an incorrect version of software.
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message…
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels…
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7…
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7…
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels…
Certain Spectrum infusion pumps may have an incorrect version of software.
Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin…
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a…
Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as…
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Potential for faulty devices as a result of depleted batteries.
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message…
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol…
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a…
Foreign material (plastic pieces)
Potential Listeria Monocytogenes Contamination
Foreign material (plastic)
Potential to be contaminated with Listeria monocytogenes
Potential Listeria Monocytogenes Contamination
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.
