The FDA has posted 5 enforcement recalls of balloon retention type catheter devices since 2025, none of them Class I (most serious). Most recent report: Sep 16, 2026.
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Due to stain present on the surface of affected foley catheters.
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney i…
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Catheter, Retention Type, Balloon”). Informational only — verify against the FDA before acting.