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FSCAs & Recalls

A Field Safety Corrective Action (FSCA) is an action taken by a manufacturer (or MRH in Mexico) to reduce the risk of death or serious injury associated with a medical device already placed on the market. FSCAs include recalls, modifications, exchanges, and advisory notices.

When an FSCA is required​

An FSCA should be initiated when:

  • A device defect or malfunction could cause or contribute to death or serious injury.
  • A safety-related correction is required to bring a device into compliance.
  • Clinical or post-market data reveals an unacceptable risk that requires action.

The decision to initiate an FSCA should be driven by your risk management process (ISO 14971). COFEPRIS and CNFV should be notified promptly when an FSCA decision is made.

Types of FSCAs​

FSCA typeDescription
Recall (retiro)Physical return of the device to the manufacturer or MRH
Safety-related correctionModification, repair, or software update to devices in the field
Safety-related exchangeReplacement of a device with a corrected version
User advisoryHazard notice without product return, for manageable risks

COFEPRIS/CNFV notification​

The MRH must notify CNFV when an FSCA is initiated:

  • Notification should include the FSCA rationale, scope, action plan, and timeline.
  • COFEPRIS may coordinate with international regulators if the issue affects other markets.
  • COFEPRIS may initiate its own mandatory recall action if it deems the risk warrants regulatory intervention.

Field Safety Notice (FSN)​

A Field Safety Notice (FSN) is the formal written communication distributed to all affected customers, distributors, healthcare facilities, and healthcare professionals when an FSCA is undertaken. The FSN is a critical regulatory document and should be prepared with legal and medical review. The FSN must:

  • Clearly identify the affected device (name, model, serial numbers or lot numbers, date of manufacture range).
  • Describe the hazard and the action required.
  • Provide instructions for the customer (return, stop use, apply correction, etc.).
  • Include contact information for the MRH.
  • Be drafted in Spanish for the Mexican market.

Record-keeping​

All FSCA activities must be documented and included in the Technovigilance Report submitted at registration renewal. Records should include:

  • The decision-making process for initiating the FSCA.
  • List of affected devices (by serial or lot number).
  • Customer contacts and responses.
  • Effectiveness checks — confirmation that the FSCA reached all affected customers.

COFEPRIS/CNFV notification​

Mandatory recalls vs. voluntary FSCAs ​ FSCAs can be either:

Voluntary — initiated by the manufacturer or MRH based on internal risk assessment. In this case, notify CNFV but retain control of scope and timeline. Mandatory — ordered by COFEPRIS when it determines an unacceptable risk exists, regardless of the manufacturer's assessment. Mandatory recalls must be implemented as directed and within COFEPRIS-specified timeframes. Failure to comply with a mandatory recall can result in:

Suspension of the sanitary registration. Administrative penalties (multas). Closure of the MRH or distributor facilities. Criminal prosecution in cases of severe patient harm. Escalation to COFEPRIS

If the MRH does not respond to CNFV notification with a timely assessment and corrective action plan, COFEPRIS may escalate to a mandatory recall without further consultation. Engage COFEPRIS early in the decision-making process for ambiguous cases.