Recall readiness means being able to stop, find and recover affected devices fast. We place inventory on hold the moment you call, produce consignee lists by lot or serial, quarantine returned product and reconcile quantities so you can close the recall with confidence.
What a recall asks of your distribution partner
FDA classifies device recalls by risk. Class I covers situations with a reasonable probability that the product will cause serious adverse health consequences or death; Class II covers problems that may cause temporary or medically reversible effects; Class III covers products unlikely to cause adverse health consequences. Under 21 CFR Part 806, manufacturers and importers must also report certain corrections and removals to FDA, generally within 10 working days when the action is taken to reduce a risk to health.
None of those decisions belong to a 3PL. What the distribution partner owns is speed and accuracy: stopping further shipments, identifying every consignee who received affected product, and controlling the physical units that remain or come back. Those three tasks determine how narrow, fast and credible your recall is.
Hold first, then scope
When you notify us of a potential issue, affected lots or serials are placed on system hold immediately, which blocks allocation to any new order, and physical stock is moved to quarantine. Orders already released but not yet shipped are intercepted where carrier pickup has not occurred.
Next comes scoping. We produce a distribution report for the affected lots or serials showing each consignee, address, quantity, ship date, order and PO references, and tracking. Because the data was captured at the unit level during fulfillment, the report is a query, not a reconstruction project. That lets your team decide recall depth, whether to the wholesale, retail or user level, from facts rather than estimates.
Returned product and reconciliation
Recovered devices are received into a dedicated recall quarantine, separate from routine returns. Each receipt is logged against the recall with lot, serial, quantity, consignee and condition, so you can track recovery progress by customer.
Reconciliation compares three numbers: units shipped to consignees, units returned or confirmed destroyed in the field, and units still on hand. Gaps become a follow-up list for your recall coordinator. When you decide disposition, we execute it as directed, whether that is return to your facility, rework under your instructions where appropriate, or destruction with documentation. Reconciliation and disposition records support the recall status reports and termination request you submit to FDA.
Mock recalls and recall plans
The best time to test recall readiness is before you need it. We run mock recalls on request: you name a lot or serial, and we measure how long it takes to place stock on hold, produce the consignee report and reconcile quantities. Results and any gaps are documented for your quality records.
We also help you write the distribution section of your recall procedure: who calls whom, what information the first call must include, how holds are authorized and released, what reports you will receive and in what format, and how returned product will be handled. Having that agreed in advance removes the most common delay in a real event, which is working out logistics while the clock is already running.
What's included
- Immediate system holds by lot, serial or item
- Interception of released but unshipped orders
- Consignee distribution reports on demand
- Dedicated recall quarantine for recovered units
- Shipped vs. returned vs. on-hand reconciliation
- Documented disposition and destruction
- Mock recall drills with timed results
Frequently asked questions
How fast can you produce a recall consignee list?
Because lot and serial data is captured during fulfillment, a consignee list for affected lots or serials is a database query and can typically be produced the same business day the request is made.
Do you notify FDA or customers during a recall?
No. Recall strategy, FDA reporting under 21 CFR Part 806 and customer notifications remain the manufacturer's responsibility. We provide the holds, distribution data, returned-product control and reconciliation that support them.
What are the classes of medical device recalls?
FDA uses three classes: Class I for a reasonable probability of serious adverse health consequences or death, Class II for temporary or medically reversible effects, and Class III for situations unlikely to cause adverse health consequences.
Can you run a mock recall?
Yes. We run mock recalls on a lot or serial you choose, time each step and document the results and any gaps for your quality records.