Ballard Closed Suction Catheters recall — FDA Z-1528-2025
Lack of sterility assurance for closed suction catheter systems
Complete FDA and NHTSA recall records dated in April 2025.
These records include useful source details for the selected month.
Lack of sterility assurance for closed suction catheter systems
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Label declares tahini paste but does not declare sesame.
Product tested positive for Listeria Monocytogenes.
Undeclared allergen: Soy lecithin, less than 2%
Potential Foreign material (plastic)
Undeclared peanuts, soy, sesame, and wheat.
Product contains cyclamates.
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies…
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Ford Motor Company (Ford) is recalling certain 2025 F-150 vehicles. The air bag warning label may be missing from the dashboard. As such, these vehicles fail to comply with the requirements…
Ford Motor Company (Ford) is recalling certain 2025 Bronco vehicles. The front upper control arm ball joint nut may be missing or tightened improperly, allowing the front upper control arm…
Honda (American Honda Motor Co.) is recalling certain 2014-2020 Acura MDX vehicles. Moisture may enter the tailgate lid light assembly and wiring harness, which can cause the interior and…
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the…
Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may…
Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
There is a potential for the sterility of the device to be compromised.
Medline medical procedure kits, containing Medtronic Aortic Root Cannula
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the…
Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
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.