Norte Recall Pressure Index
How busy was FDA’s medical-device recall desk this month, compared with a normal month of the past year? One number answers it: 100 = a normal month. Above 100, more recall activity than normal; below 100, less. Public openFDA data only.
In 30 seconds
- What it counts: recall records FDA posted for medical devices in the month, with Class I (most serious) counted ten times more than Class III (least serious).
- What 100 means: the same weighted count as the typical (median) month of the 12 months before.
- What it is not: it does not say whether devices are safe, or whether any company is doing well or badly. It is a measure of FDA recall activity, nothing more.
1 · The index, month by month
Each bar is one month. Dashed line = a normal month (100). Orange = clearly above normal (over 120), blue = near normal (80–120), grey = quieter than normal (under 80). Faded bar = month still being completed.
2 · What the recalls were made of
Same months, but showing the number of recall records by FDA class. A tall dark section means many Class I (most serious) records, which move the index most.
3 · How much of it was software
Share of the month’s recall records whose stated reason mentions “software”. Useful for software-as-a-device and connected-device teams.
Class I, II and III, in plain words
- Class I
- Reasonable chance of serious injury or death. The most serious class. Counts 10×.
- Class II
- May cause temporary or medically reversible harm; serious harm is unlikely. Most recalls are here. Counts 3×.
- Class III
- Unlikely to cause harm (for example, a labeling problem). Counts 1×.
How it is calculated
Each month: W = 10 × Class I + 3 × Class II + 1 × Class III recall records (openFDA device/enforcement, by report date). Index = 100 × W ÷ the median W of the 12 months before. Class I weighs most because it is the highest-risk class. The weights are our editorial choice and are fixed so the series stays comparable.
Worked example
In a month with 30 Class I, 248 Class II and 0 Class III records: W = 10×30 + 3×248 + 0 = 1,044. If the median W of the previous 12 months was 1,039.5, the index is 100 × 1,044 ÷ 1,039.5 = 100.4, a normal month.
All numbers, month by month
| Month | Class I | Class II | Class III | Weighted score W | Baseline (median W) | Index | Software share |
|---|
Software share = records whose recall reason mentions “software” ÷ all records that month.
Questions people ask
Is a high number bad news?
Not by itself. It means FDA posted more (or more serious) recall records than usual. One large recall with hundreds of product records can lift a month.
Why does the baseline change?
The baseline is always the median of the 12 months before, so it moves as the recent past moves. That keeps the index comparable with “now”, not with an old year.
Can I use it to judge a company?
No. It covers the whole device industry and is not about any one firm. For a company, use the free recall check.
Where does the data come from?
openFDA device enforcement records (public). The exact queries are at the bottom so anyone can reproduce every number.
How to read it, and its limits
- A record is not an event: one recall can produce many records (one per product or lot).
- Report date is when FDA classified or posted the recall, not when the problem happened.
- FDA posts weekly, so months with five posting dates score higher than months with four; that alone can move a month by up to about 25%.
- The latest month may be incomplete until openFDA refreshes (marked provisional).
- The index describes recall activity only. It is not a measure of device safety, of any company, or of investment value.
Reproduce any number:
Show the generic query template