What the FDA published this week, read for your quality system.
Medical device recalls, warning letters and regulatory changes, each linked to the official source with one practical lesson for your QMS. For quality, regulatory and manufacturing professionals, and the executives and investors who depend on them.
device recall records between 2025-10-10 and 2026-10-09: 386 Class I, 2,746 Class II and 46 Class III.
A record is not an event: one kit recall can create many records. Source: openFDA device/enforcement, accessed 2026-10-10. Verify at the official source.
Recall check: the 10 largest medtech companies
Free: pick one of the ten largest medical device companies by market value and see its FDA recall records for the last 12 months, by risk class, with a link to the official records.
| Market value | Class I | Class II | Class III | Total |
|---|---|---|---|---|
| … | ||||
Individual plan: 10 days free, then US$15 per month. Cancel anytime before day 10 and you pay nothing.
Ranking by market capitalization (companiesmarketcap.com); recall counts from openFDA device/enforcement for the window shown, updated weekly. Matching uses the firm name as FDA records it, so counts may include subsidiaries or miss renamed entities. A recall record is not a recall event. Class I = highest risk category. Informational only; not regulatory or investment advice. Spot an error? hola@norteregulatorio.com
Primary sources, always
Every data point carries a link and an access date. We separate DATA (from the source) from ANALYSIS (ours).
Read the way an audit would
Warning letters are mapped to 21 CFR 820 / QMSR sections and ISO 13485 clauses, so you know where to look in your own system.
One tool per issue
Each week, a template, checklist or prompt you can use on Monday.
Built on the US–Mexico corridor
Written natively in English and Spanish for the teams that design in the US and build in Mexico and Latin America.
What 12 months of recalls say about your QMS
| Quarter | Class I | Class II | Class III |
|---|---|---|---|
| Q4-2025 | 102 | 812 | 12 |
| Q1-2026 | 40 | 525 | 17 |
| Q2-2026 | 153 | 756 | 13 |
| Q3-2026 | 91 | 653 | 4 |
DATA: openFDA, device/enforcement, accessed 2026-10-10.
ANALYSIS: Class I is not evenly spread: Q2-2026 holds 153 records against 40 in the previous quarter. Before drawing conclusions, check whether a few kit recalls generate many records.
Lesson for your QMS: check whether your complaint process detects trends by product family, not only complaint by complaint.
Read all issues →Plans
Prices in USD plus applicable taxes; buyers in Mexico are charged in Mexican pesos (Individual MXN $279/month or $2,790/year, Team MXN $1,790/month, Executive Watch MXN $899/month). Paid plans start with a 10-day free trial: a card is required and is charged automatically when the trial ends (the date is shown at checkout) unless you cancel before then. Plans renew automatically until you cancel. Cancel anytime from the billing portal. Taxes are calculated at checkout where applicable.
Free
- Weekly FDA device newsletter in English and Spanish
- Recall check for the 10 largest medtech companies
- Norte Recall Pressure Index and market watch
- Every fact linked to the official source
Individual
- Watchlist of up to 10 companies (suppliers, customers, competitors)
- Email alerts for them: recalls (Class I flagged), FDA warning letters and close-outs, new 510(k) clearances and PMA approvals
- Up to 3 device types (FDA product codes): alerts when a recall is posted in your category
- Everything in Free
Team
- Up to 5 people
- Shared watchlist of up to 30 companies and 10 device types
- Every alert goes to the whole team
- Everything in Individual
Executive Watch
- Watchlist of up to 25 companies with all alerts
- Monthly one-page brief per watchlist: recalls by class vs prior year, warning letters, clearances and approvals, adverse-event report counts, FDA matters mentioned in SEC filings, leadership changes
- Pre-earnings fact sheet when a watched company announces its results date
- Everything in Individual
AI Kits for quality engineers
Claude Skills and Excel workbooks that organize your facts, mark what is only an assumption and what information is still needed, and prepare the questions for the person who decides. Each version adds a module for US$10 more. English and Spanish.
AI Kit 1.0
Complaints, CAPA and 8D
- Skill: complaint triage
- Skill: CAPA draft with root cause
- Skill: 8D report (D0 to D8)
- Excel: complaint log, CAPA tracker, 8D
- English and Spanish
AI Kit 1.1
Everything in 1.0 + Design Assurance
- Skill: design review prep
- Skill: design traceability check
- Skill: design change assessment (510(k) change questions)
- Excel: traceability matrix, design review checklist, change impact
- Based on public FDA guidance
AI Kit 1.2
Everything in 1.1 + Risk Management
- Skill: hazard analysis builder
- Skill: FMEA draft
- Skill: risk file review
- Skill: postmarket risk feedback
- Excel: risk register, risk matrix, FMEA, postmarket inputs
Coming soon. The Kits are not for sale yet; subscribe to the free newsletter to hear when they open.
Guides and drafting aids, not a validated CAPA, design-control or risk-management system. Use your organization’s own approved systems for regulated records.