September 10, 2026
AgencyWhat Happens When a Medical Device Gets Recalled — And How Insurance Factors In
Nearly all medical device recalls are technically voluntary — but that label is doing more work than it should. This guide breaks down the real difference between voluntary and mandatory recalls, why standard product liability policies almost never cover recall expenses, the true operational cost of pulling a device from the field, and how to build recall preparedness into your risk framework before the FDA calls.