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Recent FDA Class III device recalls

11 recent FDA Class III device recalls are listed from U.S. FDA openFDA, dated 2026-10-07 to 2026-10-21; the most frequent is Mindray DS USA, Inc. with 8. Data last updated 2026-11-03; each record links to its official source and a full report.

Data as of · Compiled by Zalwin from U.S. FDA openFDA

Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe

Free sample: 3 records (CSV)

11 records from U.S. FDA openFDA, dated 2026-10-07 to 2026-10-21. Most frequent: Mindray DS USA, Inc. (8). Each record links to a full report and the official source.

Last updated 2026-11-03. Source: U.S. FDA openFDA.

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Records
11
Most frequent
  1. Mindray DS USA, Inc. (8)
  2. Magellan Diagnostics, Inc. (1)
  3. Medical Action Industries, Inc. 306 (1)
  4. HeartSine Technologies Ltd (1)

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What are the top recent FDA Class III device recalls right now?

RecordSpecialtyTypeDate
Class III recall Z-0162-2027: Magellan Diagnostics, Inc.OtherClass III2026-10-21
Class III recall Z-0109-2027: Mindray DS USA, Inc.OtherClass III2026-10-14
Class III recall Z-0110-2027: Mindray DS USA, Inc.OtherClass III2026-10-14
Class III recall Z-0069-2027: Medical Action Industries, Inc. 306OtherClass III2026-10-14
Class III recall Z-0112-2027: Mindray DS USA, Inc.OtherClass III2026-10-14
Class III recall Z-0111-2027: Mindray DS USA, Inc.OtherClass III2026-10-14
Class III recall Z-0115-2027: Mindray DS USA, Inc.OtherClass III2026-10-14
Class III recall Z-0113-2027: Mindray DS USA, Inc.OtherClass III2026-10-14
Class III recall Z-0116-2027: Mindray DS USA, Inc.OtherClass III2026-10-14
Class III recall Z-0114-2027: Mindray DS USA, Inc.OtherClass III2026-10-14
Class III recall Z-3270-2026: HeartSine Technologies LtdOtherClass III2026-10-07

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510(k) clearances (414) Class II device recalls (320) Class I device recalls (19)

Browse by specialty

Radiology (56) Orthopedic (53) Cardiovascular (52) General & Plastic Surgery (44) Dental (32) Gastroenterology & Urology (27) Neurology (23) Microbiology (21) Clinical Chemistry (15) General Hospital (14) Anesthesiology (12) Obstetrics & Gynecology (9) Ophthalmic (7)

Browse by record type by specialty

Radiology devices: recent FDA 510(k) clearances (56) Orthopedic devices: recent FDA 510(k) clearances (53) Cardiovascular devices: recent FDA 510(k) clearances (52) General & Plastic Surgery devices: recent FDA 510(k) clearances (44) Dental devices: recent FDA 510(k) clearances (32) Gastroenterology & Urology devices: recent FDA 510(k) clearances (27) Neurology devices: recent FDA 510(k) clearances (23) Microbiology devices: recent FDA 510(k) clearances (21) Clinical Chemistry devices: recent FDA 510(k) clearances (15) General Hospital devices: recent FDA 510(k) clearances (14) Anesthesiology devices: recent FDA 510(k) clearances (12) Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9) Ophthalmic devices: recent FDA 510(k) clearances (7)

Frequently asked questions

How many recent FDA Class III device recalls are listed?

11 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-21.

Can I get alerts for Class III device recalls?

Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page.

Source: U.S. FDA openFDA. Informational only. RSS feed of new records

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