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Finance records an expired implant on a consignment shelf as a write-off. A regulator calls it evidence you can’t say where your product is. In 2024, Class I medical device recalls hit their highest level in fifteen years.
Recalls at a fifteen-year high, and manufacturers couldn't say where their devices went
In 2024, medical device recalls hit a four-year high, more than a thousand separate events. Class I recalls, the class reserved for a reasonable probability of death or serious injury, reached their highest level in fifteen years. Reviewing the recall process over that same period, a federal watchdog found manufacturers were failing to produce the list of where their product went.*
Somewhere in your network, right now, there's an implant sitting on a shelf in a hospital that your team hasn't seen in ages. It expired last month. Nobody knows it's there.
You have a tidy name for it: a write-off. When someone eventually stumbles upon it in a physical count, the value comes off the books; everyone sighs, and moves on. That's the comfortable version of this story, and it's the one a lot of companies tell themselves.
The risk of expired inventory reaching a patient
Now tell the other version.
The count doesn't find it first. A case does.
The surgery schedule is packed and this implant on the shelf is the: right size, right system, packaging intact. Nobody scrutinizes the small date printed on the label, because nobody has a reason to. The system says inventory is inventory. It ends up in a patient.
Now the write-off has a body attached to it: a patient who received a device that should have been pulled from circulation, a surgeon who has to be told, a quality team that now owns an investigation, and a regulator who is going to ask the one question you cannot answer: how did you not know it was there and expired?
The expired implant isn't a liability on your balance sheet. It's a liability with a pulse.
You might be telling yourself that in the real world, nobody would ever use it.
That’s wishful thinking. The reality is that there is no way to ensure nobody will use it, if you don’t know it’s there.
So think of every expired unit as a landmine you buried in your own supply chain. Each one, with no expiry alert and no chain of custody, is a small charge sitting in the field, harmless right up until the moment someone steps on it. You don't know how many you've laid. You don't know where they are. And your only detection system is the hope that a physical count finds each one before a case does. That isn't a compliance program. It's a coin flip with a patient on the other side.
One unit you can’t see, three problems
On paper, expiry is a numbers problem. In practice, it's far more dangerous. Treating it as a margin problem understates it by an order of magnitude.
Look at the same expired unit through three lenses.
- As a financial event, it’s the cheapest version of itself, and even that costs more than the write-off suggests. Depending on the device and your validations, the unit may be recoverable, but recovering it means reverse logistics, inspection, and a quality review. If it isn’t recoverable, that’s replacement cost on top.
- As an operational event, it’s worse. Withdrawing expiring stock is ordinary quality control, and teams plan those withdrawals constantly. The problem is the residue: for all that effort, low visibility leaves some units in the field anyway. And when a recall lands, most of which have nothing to do with expiration, that same gap runs under a deadline and a spotlight. Identify every affected unit, trace where each one went, notify accounts, pull stock. A recall is brutal precisely when your visibility is weakest, because it’s nothing but a chain-of-custody exercise.
- As a regulatory and patient-safety event, it's the one that ends careers. An expired device with no traceability is exactly what an FDA inquiry pulls the thread on, and “we didn't have a formalized way to track it” is the worst answer you can offer in that room. Behind all of it sits the outcome nobody wants to face: a negative patient result that could have been reasonably avoided, and the legal discovery that follows. Your finance dashboard won't flag this, but an auditor will. A plaintiff's attorney will.
This isn't hypothetical, and what’s worse, it’s not even rare: Medical device recalls hit a four-year high in 2024. With more than a thousand separate recall events, Class I recalls (reserved for a reasonable probability of serious injury or death) reached their highest level in fifteen years, according to Sedgwick's U.S. Recall Index, and they are the smallest share of a much larger volume.
A recall, once it starts, becomes a records exercise almost immediately. FDA's recall rules (21 CFR 806) require the company to hand over the expiration dates and a full list of every consignee, with the quantities and dates shipped to each. The 2025 GAO review of the recall process found that one reason recalls drag on is manufacturers failing to provide exactly that information up front, which is a bureaucratic way of saying they cannot reliably say where their own product went. That is a chain-of-custody failure, and it is on the record.
In every one of those scenarios, your exposure comes down to a single thing: whether you can prove where the product was and when. Call chain of custody “paperwork” if you like, but it is the whole difference between “we caught it, here's the record, here's who we notified” and “we're not sure.” One of those is a controlled process. The other is a headline. Both trace back to the same thing buried in your write-off line.
Inventory visibility provides the sharpest advantage
The solution doesn't require anything supernatural or even complicated. It just requires visibility. With real-time field tracking, an aging unit never just appears close to or past its expiry date, it remains always visible with a realtime ticker accessible for all, so there’s ample time to rotate it to a busier account or pull it back before it can ever become a hazard. The potential write-off becomes a redeployment. The landmine gets defused before anyone steps on it. And when a recall or an audit does come, the answer is already sitting there, assembled.
Movemedical is a comprehensive field inventory automation platform, purpose-built for exactly this: tracking all field inventory down to the piece, serialized or not, everywhere, in real time including expirations. Every unit carries a full chain of custody: where it is, how it got there, and who handled it along the way.
So picture getting the call. The FDA is on the line with one question: do you know where every unit is? Without a system, that question starts a scramble that can run for weeks. With Movemedical, you answer it before the call ends. No guesswork means happy FDA.
Companies running Movemedical are not answering for the problem. They're ahead of it.
Your Counting Method Is the Actual Exposure
Knowing where every unit is doesn’t start with a platform migration. It starts with something you haven’t measured: how many at-risk units are sitting in your network right now processes are in play for managing your field inventory, what workarounds are currently in play for mitigating those visibility and traceability gaps, and what they’re costing you today.
A Field Inventory Management Value Assessment examines how counting gets done: how often, by whom, and with what tooling. It identifies where in your channel the visibility gaps open, which of those gaps put expiring stock most at risk, and what the workarounds cost in rep time and recoverable value. You get an executive-ready business case scoped to your operations, not industry averages. No new hardware. No signed contract.
Request your FIM Value Assessment
Sources
Sedgwick, 2025 U.S. State of the Nation Recall Index (15 Year High)
24x7mag, Medical Device Recalls Reach Highest Level in Four Years
U.S. FDA, Recalls, Corrections and Removals (Devices), 21 CFR 806
U.S. Government Accountability Office, Medical Device Recalls (GAO-26-107619), 2025
