Cook Medical Hiatal Hernia Graft Recalled for Documentation and Labeling Errors
Cook Biotech is recalling 6 hiatal hernia grafts (Lot #LB1579758) due to incorrect Instructions for Use and wrong expiration dates on two units.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA recall with no reported illnesses, injuries, or adverse events. The hazard is documentation and labeling error rather than a physical product defect. Per the rubric, minor labeling errors without demonstrated harm are classified as Moderate.
Plain-English summary
Cook Biotech, Inc. is recalling 6 Biodesign Hiatal Hernia Grafts (REF C-PHR-7X10-U, REF G31455, Lot #LB1579758, expiring 2/19/2026) due to documentation errors. An outdated version of the Instructions for Use was provided with the devices, and two units were labeled with incorrect expiration dates.
The affected devices were distributed to medical facilities in Indiana and Michigan in the United States, as well as to Canada and South Korea.
No adverse events or injuries have been reported. Healthcare providers and patients with these devices should verify they have the correct version of the Instructions for Use and confirm the expiration dates before use.
The recalled product
- Product
- Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
- Manufacturer
- Cook Biotech, Inc.
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #LB1579758
- exp. 2/19/2026
- Box UDI-DI 10827002314556
- Pouch UDI-DI 00827002314559.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Cook Biotech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Cook Biotech, Inc.
See all →- ModerateBiodesign Otologic Butterfly Graft Recall: Incorrect Instructions and Expiration Date
FDA (Devices) · 2025-01-22
- ModerateCook Medical Biodesign Dural Graft Recalled for Incorrect Expiration Date and Instructions
FDA (Devices) · 2025-01-22
- HighCook Biotech Fistula Plug recalled for expiring before labeled date
FDA (Devices) · 2024-10-02
- HighBiodesign Recto-Vaginal Fistula Plug units expire before labeled date
FDA (Devices) · 2024-10-02
- HighBiodesign Recto-Vaginal Fistula Plug expires before labeled expiration date
FDA (Devices) · 2024-10-02
Same hazard · mis labeling
See all →- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White Herbal Supplement Recalled for Undeclared Walnut Allergen
FDA (Food) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- HighHalyard DAVINCI TRUCUSTOM Foley Catheter Kits Recalled for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02