Quantity is a sentence, not a number

Ask how many units a quarter’s device recalls actually affected, and there is a field built to answer exactly that question. FDA’s own Enforcement Report definitions describe it plainly: quantity is the amount of defective product subject to recall. Pull the field from openFDA’s device enforcement records and the answer is a string of prose written by whoever filed the report, not a count that adds up.

What the field actually holds

product_quantity is typed as free text in openFDA’s device enforcement schema — FDA Radar’s own ingestion adapter declares it a string, the same type openFDA itself returns. A firm can and does write a bare figure into it. It can just as easily write a sentence: units broken out by lot, a note that the true count was never confirmed, a figure qualified by “approximately,” a distribution described in cases rather than devices. The field was built to answer how much, and FDA never constrained the shape the answer has to take.

Why that breaks a total before you start

Sum a column of numbers and the result is a number. Sum a column where some rows are numbers, some are prose, and some read “unknown, firm still investigating,” and the result is whatever a parser did with the rows it couldn’t read — usually silence, sometimes a zero standing in for a quantity that was never actually zero. A total built on the assumption that quantity is an integer drops exactly the recalls whose scope is least understood, which is close to the opposite of the recalls a reader would most want a total to include.

What FDA Radar does with it today

The field arrives in the same payload as recall_number and reason_for_recall, and FDA Radar’s enforcement ingestion carries it into the source text a reviewer reads, prose and all — never into a structured fact, and never summed. There is no total-units figure anywhere downstream of it, on purpose: a number computed by silently skipping the rows it can’t parse is a worse thing to publish than no number at all.

The practice

Treat quantity as a sentence to read, one recall at a time, not a column to sum. If a rollup number is genuinely needed, it has to be built by a person reading each entry and deciding how to interpret the ones that aren’t clean integers — a judgment call, not a spreadsheet formula. Per what FDA Radar monitors and how often, this is regulatory intelligence about how the record is built, never a determination about the actual scope of any specific recall.