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 An outdated version of the Instructions for Use was provided with the devices, and two units were labeled with incorrect expiration dates.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.
- Hazard
- mis-labeling
- incorrect-expiration
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
Distributed in 2 states:
- IN
- MI
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