GuidelinesGMP2026.10.29
A Medical Device Recall Drill: Reconcile Lots, Contacts and Quantities
A contact list alone does not demonstrate recall readiness. Follow one lot through shipment destinations, customer holdings and unresolved quantities to identify gaps in real response capability.
Key point — A recall drill tests the actual product trail. Record successful contact, confirmed location and physical return as different outcomes.
Distinguish preparedness from an actual recall
Article 31 of the Medical Devices Act addresses recall or necessary action when a product is known to cause or risk harm, and recall planning and reporting by manufacturers and importers. KGMP Annex 2 section 8.3.3 addresses action proportionate to delivered nonconforming products and advisory notice procedures that can be implemented at any time. Assess actual obligations promptly when a real issue arises.
A drill is a practical way to test readiness; this article does not impose a universal legal exercise frequency. Define the product and lot, hypothetical problem, scope, owners and completion criteria. Decide whether to use internal records only or contact customers. If external contact is included, use approved communications clearly identified as an exercise.
Select a meaningful lot
Choosing only a recent lot delivered to one customer can miss distribution weaknesses. Consider risk and routes involving distributors, split shipments, returns and warehouse transfers. A software scenario may require versions and installation targets as well as physical lots.
Keep the scope defined, then establish which records must connect: manufacturing or import records, release, delivery, onward distribution and customer status. UDI and product identifiers help identify devices, but a registered code does not by itself reveal every shipment destination and current quantity.
Test movement records and contact routes together
| Step | Evidence | Potential gap |
|---|---|---|
| Identification | Product, model, lot or serial number and version | Several lots mixed under one model |
| Shipment | Date, quantity, recipient, transfers and returns | Accounting customer differs from actual recipient |
| Contact | Current responsible person, attempts and replies | Only a former employee's email remains |
| Status | Held, used, supplied onward and returned quantities | Unknown onward recipient or balance |
| Action | Evidence of hold, return or disposition | Contact marked as completed action |
Staff recollection may conceal a missing record. Document where information came from and why additional calls or manufacturer queries were needed. Maintain appropriate business contact routes and access rather than collecting unnecessary personal details.
Reconcile without double counting
For a hypothetical 120 units, there might be 20 in company stock, 60 held by customers, 20 already used, ten physically returned and ten unknown. These sum to 120. The 60 held by customers have not been returned merely because the customer replied. Used units require separate evidence and assessment of follow-up because physical recovery may differ.
Define the denominator for any recovery rate according to the applicable plan and rules: total production or import quantity and the actual recall population may differ. Do not exclude unknown units merely to improve an exercise result. Report contact coverage, confirmed location and physically returned quantities separately. Remove units from their previous status when they move.
Turn missing information into corrective work
Unreachable recipients, missing onward-shipment records and differences between ERP and warehouse quantities need causes and accountable actions, not a generic failure label. Review what distributors are required to retain and provide, and how contacts are updated after staff or contractual changes. Consider changes to agreements or procedures where needed.
Assign the owner, target completion, record or procedure changes and verification method. Classifying every unknown unit as used would hide the weakness. Link the scenario to complaint and investigation records to test the path from the initiating signal through follow-up.
Escalate real findings beyond the exercise
Tracing records may reveal an actual lot mix-up, safety defect or unreported event. The exercise label cannot justify delaying real action. Quality and safety personnel should evaluate the actual finding separately and determine the applicable reporting and recall procedures.
The exercise report should retain the selection rationale, scope, sources, quantity reconciliation, elapsed time, gaps, actions and verification results. Clare Partners can help define an appropriate review using your product and shipment or return records through a free preliminary review.
Official sources checked on 2026-09-28: Medical Devices Act, Article 31; KGMP Notice 2026-46, Annex 2 sections 7.5.9, 8.3.3 and 8.5. Exercise methods and quantities are practical examples, not a replacement for the legal scope, deadlines or reporting forms of an actual recall.
Frequently asked questions
- Q. Is an annual mock recall a universal legal requirement?
- This guide does not present a common annual legal requirement for every device. Set the exercise scope and frequency according to applicable requirements, the quality system, contracts and risk.
- Q. Is reaching every customer enough to pass?
- Contact and product-location confirmation are different. Reconcile quantities held, used, returned, supplied onward or still unknown, with evidence for each status.
- Q. What if the exercise identifies a real defect?
- Move the finding into the actual quality and safety process. A drill cannot postpone applicable reporting or recall duties under Article 31 of the Medical Devices Act.