FDA action counts
| Total FDA actions | 2 |
|---|---|
| Warning letters | 0 |
| Recalls | 2 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | May 6, 2026 |
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. WHILL, INC. has 2 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.
Enforcement history
On 2026-05-06, Argus HQ recorded a FDA recall for WHILL, INC., rated "critical" severity in Argus HQ's classification: WHILL, INC. — Class I recall: WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for WHILL, INC., rated "critical" severity in Argus HQ's classification: WHILL, INC. — Class I recall: WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, WHILL, INC. has 2 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Counting an FDA record here does not by itself indicate an unresolved problem -- warning letters, recalls, and inspection observations are frequently closed out once a firm completes FDA-required corrective action.
Frequently asked questions
- What is the most recent FDA action against WHILL, INC.?
- The most recent FDA event Argus HQ has on file for WHILL, INC. is dated 2026-05-06, with a severity rating of "critical" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
- Does Argus HQ track new FDA actions for WHILL, INC. automatically?
- Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to WHILL, INC. is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for WHILL, INC.?
- 2 total: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for WHILL, INC.?
- May 6, 2026. Argus HQ ingests new FDA enforcement records daily.
Every FDA action tied to this company, the week it happens.
Free weekly briefing. Real-time alerts on paid plans.
Related enforcement actions
Compare with
Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Actions Against WHILL, INC.. Digital Empire LLC. Retrieved from https://argushq.ai/company/whill-inc
"FDA Actions Against WHILL, INC.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/whill-inc.
Argus HQ Research. "FDA Actions Against WHILL, INC.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/whill-inc.
@misc{argushq_argushq_ai_company_whill_inc_2026,
title = {FDA Actions Against WHILL, INC.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/whill-inc},
note = {Accessed: July 13, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗