Coloplast Manufacturing US, LLC: 9 recalls on record

Recalls filed with 1 agency: FDA (9).

First recall on record: May 29, 2013. Most recent: January 22, 2025.

Risk classification: Class II: 8 · Class III: 1

Most recent recalls

DateAgencyProduct
January 22, 2025FDAX-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, A…Z-0845-2025
April 10, 2024FDAUreteral dilator, REF RBD014Z-1463-2024
April 19, 2023FDATitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile ProsthesisZ-1366-2023
April 19, 2023FDATitan Pump Assembly, Catalog Number 5177701400; inflatable penile ProsthesisZ-1360-2023
December 29, 2021FDATorosa Saline-Filled Testicular Prosthesis (Size Small)Z-0413-2022
November 5, 2014FDAColoplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urin…Z-0155-2015
November 5, 2014FDABiatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Orig…Z-0138-2015
June 12, 2013FDADigitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52…Z-1486-2013
May 29, 2013FDARostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 …Z-1341-2013

Questions about this company

How many recalls does Coloplast Manufacturing US, LLC have?
Recalert has 9 U.S. recalls on record for Coloplast Manufacturing US, LLC, published between May 29, 2013 and January 22, 2025.
What was the most recent Coloplast Manufacturing US, LLC recall?
FDA recall Z-0845-2025, published January 22, 2025: X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522,…
Which agencies have handled Coloplast Manufacturing US, LLC recalls?
Coloplast Manufacturing US, LLC appears as the recalling firm in recalls from: FDA (9).

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