Guide
Recalls in a device’s family tree
19% of the 510(k)s cleared 2021–2025 whose predicates we could read cite at least one predicate that has been recalled; 1.6% cite one with a Class I recall, FDA’s most serious class, and 13% have a Class I recall somewhere among their ancestors. Of 510(k)s cleared 2012–2019, 25% of those citing a recalled predicate have been recalled themselves, against 7% of those whose predicates have no recall.
Figures from FDA decisions to Oct 23, 2026 recomputed weekly, last Nov 3, 2026
Cite a recalled predicate
19%
of 510(k)s, 2021–2025
Class I recall among ancestors
13%
of 510(k)s, 2021–2025
Later recalled, recalled predicate
25%
cleared 2012–2019
Later recalled, no recalled predicate
7%
cleared 2012–2019
Why a predicate’s recall matters
A 510(k) borrows its predicate’s design as the baseline for equivalence. When that predicate was recalled for its design, a component or its software, the same weakness can travel into the devices built on it.
The record bears that out. Of the 7,143 510(k)s cleared 2012–2019 that cite a recalled predicate, 25% have since been recalled themselves; of the 15,037 whose predicates have no recall, 7%. For Class I, the gap is wider: 23% against 0.6%.
Part of that is one recall naming both devices, as when a company recalls a product line: of the 1,802 devices recalled after citing a recalled predicate, 28% were named in the same recall as their predicate. The rest were recalled on their own.
Recalls by year
Device recalls per year, by class
377Class I in 2025
Class I Class II/III not classified
Check your predicate’s family tree before you file. A 510(k) Report weighs every candidate predicate’s family-tree recall history alongside its fit with your device. $995, emailed as a PDF, usually within a few hours.
What causes recalls
The root causes FDA recorded for recalls that began in 2021–2025, in its own words. “Under investigation by firm” means the company had not yet found the cause when FDA posted the recall.
| Root cause | Recalls |
|---|---|
| Under Investigation by firm | 3,569 |
| Process control | 2,088 |
| Device Design | 1,476 |
| Nonconforming Material/Component | 1,073 |
| Software design | 679 |
| No Marketing Application | 556 |
| Process change control | 357 |
| Other | 281 |
Product codes with the most Class I recalls
| Product code, Class I recalls 2021–2025 | Recalls |
|---|---|
| CBK Ventilator, Continuous, Facility Use | 40 |
| DSP System, Balloon, Intra-Aortic And Control | 36 |
| EOQ Bronchoscope (Flexible Or Rigid) | 28 |
| LWP Implantable Pulse Generator, Pacemaker (Non-Crt) | 25 |
| FRN Pump, Infusion | 20 |
| BSZ Gas-Machine, Anesthesia | 20 |
| FMF Syringe, Piston | 18 |
| QKP Coronavirus Antigen Detection Test System. | 14 |
| GEI Electrosurgical, Cutting & Coagulation & Accessories | 14 |
| OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of… | 12 |
How to check a predicate
Every device page lists the recalls of the device itself and of the devices in its family tree, with their class and FDA’s stated reason. Before settling on a predicate, look at its page, then at its own predicates’ pages: a Class I recall two generations back is still part of the history your 510(k) inherits.
Doing this for your own device? A 510(k) Report starts from your device concept: it finds the product code and pathway, ranks candidate predicates side by side, and weighs their family trees’ recall history and review times. $995, emailed as a PDF, usually within a few hours.
How these figures are computed
Recalls come from FDA’s recall and enforcement records, matched to devices through the 510(k) and PMA numbers FDA lists on each recall. “Recalled predicate” means a direct predicate named in at least one recall at any time. The later-recall comparison covers 510(k)s cleared 2012–2019 whose summaries name a predicate we could read, so each has had at least seven years in which to be recalled. The figures are recomputed from FDA’s records every week; see the methodology.