CLASS II ONGOING Device recall · Reported 2 Oct 2024 · FDA Enforcement Report

Biodesign Fistula Plug C-fps recalled by Cook Biotech

Cook Biotech is recalling Biodesign Fistula Plug C-fps-0.4 - For implantation to reinforce soft tissue for repair, distributed nationwide in the US. The recall was initiated on 7 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (01)00827002546134(17) Lot Number: LB1524439 LB1524440 LB1524442 LB1524443 LB1524445 LB1524463 LB1524466 LB1524468 LB1524475 LB1524479 LB1524481¿ LB1524490 LB1524493 LB1525896 LB1525901 LB1525907 LB1526905 LB1527067 LB1527075 LB1530306 LB1530313 LB1531711 LB1531739 LB1533341 LB1533352 LB1536078 LB1536107 LB1537839 LB1537859 LB1539734 LB1539735 LB1540185

Quantity recalled93

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3253-2024
FDA event ID: 95149
Recalling firm: Cook Biotech, W Lafayette, IN
Classification: Class II
Status: Ongoing
Recall initiated: 7 Aug 2024
FDA classified: 25 Sep 2024
Reported: 2 Oct 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

7 Aug 2024	Recall initiated by company
25 Sep 2024	Classified by FDA	+49 days
2 Oct 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Products expire prior to the expiration date printed on the product labeling

Product as listed by the FDA

Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Products expire prior to the expiration date printed on the product labeling

Which lots are affected?

UDI: (01)00827002546134(17) Lot Number: LB1524439 LB1524440 LB1524442 LB1524443 LB1524445 LB1524463 LB1524466 LB1524468 LB1524475 LB1524479 LB1524481¿ LB1524490 LB1524493 LB1525896 LB1525901 LB1525907 LB1526905 LB1527067 LB1527075 LB1530306 LB1530313 LB1531711 LB1531739 LB1533341 LB1533352 LB1536078 LB1536107 LB1537839 LB1537859 LB1539734 LB1539735 LB1540185

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

11 other products · FDA event 95149

This product is part of a recall event; the main page for the event is Biodesign Inguinal Hernia Graft C-ihm recalled by Cook Biotech.

Reported	Class	Recall	Company	Reason	Where
2 Oct 2024	CLASS II	Biodesign Inguinal Hernia Graft C-ihm recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Fistula Plug C-fpb recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Recto-Vaginal Fistula Plug RVP recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Recto-Vaginal Fistula Plug RVP recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Fistula Plug C-fpb recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Recto-Vaginal Fistula Plug RVP recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide

More recalls from Cook Biotech

All 15

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025Device	CLASS II	Cook Medical Biodesign Dural Graft recalled by Cook Biotech	Cook Biotech	Other	MI
22 Jan 2025Device	CLASS II	Cook Medical Biodesign Otologic Butterfly Graft recalled by Cook Biotech	Cook Biotech	Other	MI
22 Jan 2025Device	CLASS II	Cook Medical Biodesign Hiatal Hernia Graft recalled by Cook Biotech	Cook Biotech	Other	MI
2 Oct 2024Device	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024Device	CLASS II	Biodesign Recto-Vaginal Fistula Plug RVP recalled by Cook Biotech	Cook Biotech	Other	Nationwide

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All 13,908

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14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide