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Independent FDA recall newsroom

FDA Medical Device Recalls

Every Class I, II, and III device recall from FDA enforcement reports — searchable, explained, and updated daily.

Check if your device is recalled

Search by device, brand, or manufacturer. On any recall page, paste your lot, serial, or REF number to check it against the FDA's listed codes.

Class ILatest Class I

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600

Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

The Wire

Latest FDA device recalls

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Severity watch

Class I: the most serious FDA actions

All Class I
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Recalls by device type

From imaging systems to infusion pumps — every device category with recalls on record.

All 222 device types
Root causes

Recalls by root cause

What actually goes wrong: design flaws, software defects, process failures.

All root causes
The data

FDA device recall statistics

Recalls tracked
4,996
Class I — most serious
634
Ongoing
4,960
Reported last 90 days
724
Methodology

How RecallWatch reports FDA recalls

  • Every record comes from the U.S. FDA's official openFDA device enforcement reports, enriched with the FDA's recall (RES) records — root cause, device classification, and firm actions.
  • The database syncs with the FDA every six hours. Recalls appear here as soon as the FDA posts them — severity-first, with the affected lots and codes made searchable.
  • RecallWatch is independent and not affiliated with the U.S. FDA. Read our editorial policy and methodology. Do not rely on this site to make decisions regarding medical care — always speak with your health provider about the risks and benefits of FDA-regulated products, and verify against the FDA's official record before acting.
Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.