Medical Device Recalls: Is Your Value Chain “Recall Ready”?

Recently the FDA published a guidance requiring device manufacturers to be ready for a medical device recall noting, “It is critical that all companies in the supply chain are ‘recall ready’ to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain”. While most manufacturers might already take that level of preparation to heart having prepared plans and systems to deal with a medical device recall event, the recent supply chain breakdowns highlight how important it is to construct flexibility with our inventory supply and expand our capabilities when it comes to managing medical inventory.

Even if standard procedures exist to handle a medical device recall, it’s important to smoke test our existing structures and practices to ensure that the process functions as intended and can be used to pull inventory back and prevent further use. 

Now is the perfect time to reassess your readiness in the face of a medical device recall. As previously mentioned, we’ve recently seen the impact a shortage of inventory can have on the healthcare landscape and a recall can impact this just as much as a material shortage. Preparing for a medical device recall scenario so that inventory can quickly be pulled from the field and replaced with compliant product to prevent a disruption in care or service is critical both to patient safety as well as to business operations. 

Additionally, the ability of manufacturers to prevent harm from their products is paramount in a medical device recall scenario. The FDA guidance suggests manufacturers should maintain ‘thorough and organized distribution records to assist in effective recalls. A key component of a recall plan being the ability of a manufacturer to communicate with the field what must be returned. This starts with knowing where the non-compliant inventory is and where it has been previously used. 

Maintaining inventory traceability with a field inventory management system, such as ConnectSx, can deliver critical value when you are faced with the task of tracking down recalled inventory. With a system in place, especially one purpose-built for these needs, you can easily identify where all inventory is located, where it has been used, and track whether it has all been recalled. It can also simplify the establishment of controls so recalled inventory can no longer be billed for and you can initiate its transfer back to a quarantined warehouse. 

During 2021, 3 Recalls occurred that involved more than 100 million units, while one recall implicated 267 million units. The total number of medical devices recalled in 2021 was in excess of 602 million. When one missed device could be responsible for adverse impacts to a patient, you can not afford to leave it to chance. Keep track of your inventory throughout the value chain with an immutable chain of custody and make sure you are prepared if a recall becomes necessary.

If you’re thinking about building your company’s capability to respond to a recall, reach out to learn how ConnectSx can help.

How Beacon Supports Medical Device Recalls

In the event of a medical device recall, speed and accuracy are everything. Beacon delivers real-time inventory visibility so manufacturers and distributors know exactly where affected products are—whether in the warehouse, in the field, or already consigned at hospitals. With built-in inventory control and detailed movement tracking, Beacon makes it easy to isolate recalled items, initiate returns, and redeploy unaffected inventory without guesswork. The result is faster, more efficient recall management that minimizes risk, reduces costs, and protects both patient safety and brand reputation. If you’re unsure if your operation needs help, try out our free readiness assessment to get your score.