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FDA-Initiated Mandatory Recall — §518(e)

US-unique

The FDA's authority to order a mandatory recall of a medical device under § 518(e) is a US-specific power. Most recalls in practice are voluntary — mandatory recalls are rare but represent FDA's strongest post-market enforcement tool short of seizure.

Authority​

Under FD&C Act § 518(e) [21 U.S.C. § 360h(e)], FDA has the authority to order a recall of a device that presents an unreasonable risk of substantial harm to the public health, when FDA determines that:

  • There is a reasonable probability that a device intended for human use would cause serious adverse health consequences or death; and
  • The manufacturer/importer has not initiated a voluntary recall

Process for mandatory recall order​

  1. FDA notifies the manufacturer/importer in writing of the proposed order and the basis for it
  2. The manufacturer/importer has 10 days to request an informal hearing
  3. If a hearing is requested, FDA holds an expedited hearing
  4. FDA issues a final order, which is published in the Federal Register
  5. FDA monitors compliance

Mandatory recall vs voluntary recall​

In practice, the vast majority of US device recalls are voluntary — initiated by the manufacturer in response to identifying a safety issue, sometimes in dialogue with FDA. FDA rarely needs to invoke its § 518(e) authority because manufacturers generally cooperate.

The existence of § 518(e) authority serves as an important backstop encouraging voluntary cooperation.

Official resources​