How many FDA warning letters has Abbott Medical received?

Argus HQ has not recorded an FDA warning letter for Abbott Medical in our current dataset.

What FDA recalls has Abbott Medical issued?

Argus HQ has recorded 1 FDA recall tied to Abbott Medical.

Is Abbott Medical FDA compliant?

Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 1 recall, and 0 approval records for Abbott Medical. Review the linked FDA source records directly before drawing a compliance conclusion.

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company

Abbott Medical

Name: FDA Enforcement Actions Against Abbott Medical
Creator: Argus HQ
License: https://argushq.ai/methodology

Jurisdiction: US

FDA Warning Letter timeline

V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.

fda_recall · device_recall2026-06-17
Abbott Medical — Class II recall: Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 33…

Frequently asked questions

How many FDA warning letters has Abbott Medical received?: Argus HQ has not recorded an FDA warning letter for Abbott Medical in our current dataset.
What FDA recalls has Abbott Medical issued?: Argus HQ has recorded 1 FDA recall tied to Abbott Medical.
Is Abbott Medical FDA compliant?: Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 1 recall, and 0 approval records for Abbott Medical. Review the linked FDA source records directly before drawing a compliance conclusion.

Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.