Drug & Device Safety Atlas

FDA recall record · openFDA

Coloplast Manufacturing US, LLC

20 FDA recalls on record (2023–2024) — 20 device. 20 still ongoing.

0
Class I (most serious)
20
Class II
0
Class III
20
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thick 16
A possible sterility issue was detected in Coloplast's facility on some Coloplast products. 2
XXX 1
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral di 1

Recalls

X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, Class II 2024-12-02 Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA612 Class II 2024-12-02 Ureteral dilator, REF RBD014 Class II 2024-03-11 Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis Class II 2023-03-01 Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis Class II 2023-03-01 Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis Class II 2023-03-01 Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis Class II 2023-03-01 Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis Class II 2023-03-01 Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis Class II 2023-03-01 Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis Class II 2023-03-01 Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis Class II 2023-03-01 Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis Class II 2023-03-01 Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis Class II 2023-03-01 Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis Class II 2023-03-01 Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis Class II 2023-03-01 Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis Class II 2023-03-01 Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis Class II 2023-03-01 Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis Class II 2023-03-01 Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis Class II 2023-03-01 Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis Class II 2023-03-01

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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