Biodesign Inguinal Hernia Graft Recall Due to Premature Expiration
Cook Biotech is recalling Biodesign Inguinal Hernia Graft units because products expire before their labeled expiration date, potentially affecting surgical outcomes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: FDA Class II recall of a surgical implant with a device expiration defect. No illnesses, injuries, or deaths have been reported. The hazard is a real defect affecting device function, but without documented patient harm.
Plain-English summary
Cook Biotech is recalling 120 units of Biodesign Inguinal Hernia Graft C-IHM-10X15 worldwide, including distribution throughout the United States, Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, and South Africa.
The affected products expire prior to the expiration date printed on the product labeling. This graft is used during hernia repair surgery to reinforce soft tissue in the inguinal floor. Devices that expire before their labeled expiration date may not maintain their intended structural and functional properties.
If you are a healthcare provider or facility that received these affected lots, do not use them for patient procedures. Surgeons and hospital staff should contact Cook Biotech for instructions on returning the affected devices. Patients who have already had these devices implanted should consult with their surgeon about monitoring or any necessary follow-up care.
The recalled product
- Product
- Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
- Manufacturer
- Cook Biotech, Inc.
- Affected units
- 120
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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.
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