CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Cook Medical Biodesign Dural Graft recalled by Cook Biotech
Cook Biotech is recalling Cook Medical Biodesign Dural Graft, distributed in Michigan. The recall was initiated on 22 Nov 2024 and the FDA has classified it as Class II.
Check your package
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-0834-2025
- FDA event ID
- 95961
- Recalling firm
- Cook Biotech, W Lafayette, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Nov 2024
- FDA classified
- 10 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Nov 2024 | Recall initiated by company | |
| 10 Jan 2025 | Classified by FDA | +49 days |
| 22 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Product as listed by the FDA
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Where it was distributed
US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
Questions about this recall
Why was it recalled?
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Which lots are affected?
Lot #LB1581197, exp. 2/4/2026, Box UDI-DI 10827002310916; Pouch UDI-DI 00827002310919.
Where was it sold?
US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
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
2 other products · FDA event 95961This product is part of a recall event; the main page for the event is Cook Medical Biodesign Hiatal Hernia Graft recalled by Cook Biotech.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cook Medical Biodesign Hiatal Hernia Graft recalled by Cook Biotech | Cook Biotech | Other | MI | |
| CLASS II | Cook Medical Biodesign Otologic Butterfly Graft recalled by Cook Biotech | Cook Biotech | Other | MI |
More recalls from Cook Biotech
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cook Medical Biodesign Otologic Butterfly Graft recalled by Cook Biotech | Cook Biotech | Other | MI |
| Device | CLASS II | Cook Medical Biodesign Hiatal Hernia Graft recalled by Cook Biotech | Cook Biotech | Other | MI |
| Device | CLASS II | Biodesign Fistula Plug C-fps recalled by Cook Biotech | Cook Biotech | Other | Nationwide |
| Device | CLASS II | Biodesign Fistula Plug C-fps recalled by Cook Biotech | Cook Biotech | Other | Nationwide |
| Device | CLASS II | Biodesign Recto-Vaginal Fistula Plug RVP recalled by Cook Biotech | Cook Biotech | Other | Nationwide |
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