Twenty minutes a month: turning other companies' recalls into PMS input

Your PMS plan requires you to collect publicly available information about similar devices.

It is written in MDR Annex III, section 1.1, and it is repeated in clause 10 of ISO 14971 and clause 8.2.1 of ISO 13485.

In practice, this is one of the requirements that tends to stay on paper and only comes up for discussion when an audit or a management review is approaching.


The requirement is worded in open terms, and a one-person QA/RA function that tries to meet it literally ends up reading FDA publications every morning without knowing when it is enough. What works is a short, fixed routine that produces a record, not wider reading.

In one week in early September 2026, the FDA published seven recalls and an Early Alert. I will use them to show how this works.

First, the difference between an Early Alert and a classified recall. This is the most confusing part, and it changes what you are allowed to conclude.

  • A classified recall is a notice for which the FDA has already determined that the company's action meets the regulatory definition of a recall, and has classified it by severity (Class I, II or III).

  • An Early Alert is something else. The FDA launched it as a pilot in November 2024 and expanded it to all device types on September 29, 2025. It is published before the classification is decided, and the FDA's wording is explicit: it may not yet have been determined that the company's action meets the definition of a recall.

Here is what this means for you in practice:

  • An Early Alert is an early indication, not a finding. You can open an internal review because of it, but you cannot base a conclusion about a competitor's device on it.

  • The time gap between the Early Alert and the classification is a window in which the information is already public but not yet final. If you monitor competitors, this is the window to pay attention to.

  • An item that appears first as an Early Alert and later as a classified recall is the same event. Do not count it twice in your PMS table.

The pattern that came up this week

Of the seven items, three involved convenience kits or breathing circuits. One of them shows a point that comes up for everyone who assembles kits: Medline issued a correction for kits it assembles because of BD ChloraPrep products that were included in them. The company that assembled the kit is the one handling the field action, but the source of the problem is a supplier's component.

What this means for your file. If your device is sold as a kit, or if you build supplier components into a finished product, it is worth checking three things in your supplier agreement and your purchasing procedure:

  1. Advance notification obligation. Is the supplier contractually required to notify you of complaints, recalls and corrective actions it takes on the component you buy, and within what timeline? Without such a clause, you will get the information at the same time as everyone else, from the FDA's public posting.

  2. Change notification obligation. A change in formulation or process at the supplier that was not reported to you can introduce a problem in the middle of a series that was fine until then.

  3. What incoming inspection really checks. In most cases, incoming inspection of a packaged component comes down to checking the documentation and the quantity. That is a legitimate decision, provided it is documented as a risk-based decision.

What goes into the file, and what does not

The common mistake is to turn every item into a document. A one-person QA/RA function that tries to write a full analysis of every competitor recall abandons the routine after two months.

The record you need is short: the date of the review, the sources reviewed, the items found relevant, and the decision on each one.

An item that is not relevant is recorded in one line, with the reason.

An item that is relevant gets a reference to where it was passed on, for example to risk management or to the PMCF plan.

In an audit, the auditor checks that your plan says you review information on similar devices, and that there are records showing you did.

The number of analyses is not the measure.

As an example, take an Israeli manufacturer of a monitoring device with a single-use breathing circuit component. In the monthly review, the manufacturer sees the Medline recall of heated breathing circuits for infants and premature babies. Their device is intended for adults, and their component is not heated. Their record looks like this:

October 5, 2026: Reviewed the FDA Recalls and Early Alerts pages for September 1 to 30, 2026. Item considered: Medline recall, neonatal heated breathing circuits (September 1, 2026). Not relevant to our device: different target population, and our component has no heating element. No action required. The other items in the period are not of our device type.


Four lines like these meet the requirement.

The routine itself

Once a month, at a fixed time:

  1. Open the FDA Recalls and Early Alerts page and filter for the previous month. If your device is also marketed in Europe, add a check of the publications of the local authority in your main market.

  2. Scan by device type, not by company name. You are looking for devices similar to yours, not for the competitors you follow. This is a common mistake that narrows the scan too much.

  3. Mark items for review. There are usually zero to three a month.

  4. Decide on each one. Record whether it is relevant or not, and why. A relevant item moves to the risk management file or to the PMCF, with a reference.

  5. File the record in the place your PMS plan points to, not in a separate folder nobody will remember.

Twenty minutes a month is the right order of magnitude for most small manufacturers.

If it takes two hours, your scan is probably too wide.

Three mistakes worth avoiding

  • Reviewing only direct competitors. The requirement covers similar devices, and that definition is wider than your list of competitors.

  • Documenting only positive findings. A month with no relevant item is a result, and it needs to be documented. A missing record looks like a month in which you did not review.

  • Copying the recall description into the file. The FDA's description is public information that you can refer to. What needs to be written down is your decision.