An FDA-recorded root-cause determination. The FDA lists 19 recalls with this root cause since 2025, 2 of them Class I (most serious). Most recent report: Sep 30, 2026.
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results.…
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured.…
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.
Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.
Sterile anchors my lack sterility assurance.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.