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- Class III device recalls

# 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 2026-11-04; each record links to its official source and a full report.**

Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA Copy citation

Download all 11 recent FDA Class III device recalls (CSV) — $4.99 →

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[Free sample: 3 records (CSV)](/v1/verticals/fdapulse/records.csv?record_type=Class%20III)

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 2026-11-04. Source: U.S. FDA openFDA.

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Records

11

Most frequent

- Mindray DS USA, Inc. (8)
- Magellan Diagnostics, Inc. (1)
- Medical Action Industries, Inc. 306 (1)
- HeartSine Technologies Ltd (1)

## How do I get new recent FDA Class III device recalls by email?

Search, filter and export these records, or get alerts when new ones appear.

[Search and filter](/v/fdapulse?record_type=Class%20III) [Watch this exact filter](/v/fdapulse?record_type=Class%20III#more-ways) [See alert plans](/v/fdapulse#pricing)

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

| Record | Specialty | Type | Date |
|---|---|---|---|
| Class III recall Z-0162-2027: Magellan Diagnostics, Inc. | Other | Class III | 2026-10-21 |
| Class III recall Z-0109-2027: Mindray DS USA, Inc. | Other | Class III | 2026-10-14 |
| Class III recall Z-0110-2027: Mindray DS USA, Inc. | Other | Class III | 2026-10-14 |
| Class III recall Z-0069-2027: Medical Action Industries, Inc. 306 | Other | Class III | 2026-10-14 |
| Class III recall Z-0112-2027: Mindray DS USA, Inc. | Other | Class III | 2026-10-14 |
| Class III recall Z-0111-2027: Mindray DS USA, Inc. | Other | Class III | 2026-10-14 |
| Class III recall Z-0115-2027: Mindray DS USA, Inc. | Other | Class III | 2026-10-14 |
| Class III recall Z-0113-2027: Mindray DS USA, Inc. | Other | Class III | 2026-10-14 |
| Class III recall Z-0116-2027: Mindray DS USA, Inc. | Other | Class III | 2026-10-14 |
| Class III recall Z-0114-2027: Mindray DS USA, Inc. | Other | Class III | 2026-10-14 |
| Class III recall Z-3270-2026: HeartSine Technologies Ltd | Other | Class III | 2026-10-07 |

[Browse all FDAPulse record reports](/hub/fdapulse/records)

## Which related categories and locations should I check?

### Browse by record type

[510(k) clearances (414)](/hub/fdapulse/type/510k-clearances) [Class II device recalls (320)](/hub/fdapulse/type/class-ii-recalls) [Class I device recalls (19)](/hub/fdapulse/type/class-i-recalls)

### Browse by specialty

[Radiology (56)](/hub/fdapulse/specialty/radiology) [Orthopedic (53)](/hub/fdapulse/specialty/orthopedic) [Cardiovascular (52)](/hub/fdapulse/specialty/cardiovascular) [General & Plastic Surgery (44)](/hub/fdapulse/specialty/general-plastic-surgery) [Dental (32)](/hub/fdapulse/specialty/dental) [Gastroenterology & Urology (27)](/hub/fdapulse/specialty/gastroenterology-urology) [Neurology (23)](/hub/fdapulse/specialty/neurology) [Microbiology (21)](/hub/fdapulse/specialty/microbiology) [Clinical Chemistry (15)](/hub/fdapulse/specialty/clinical-chemistry) [General Hospital (14)](/hub/fdapulse/specialty/general-hospital) [Anesthesiology (12)](/hub/fdapulse/specialty/anesthesiology) [Obstetrics & Gynecology (9)](/hub/fdapulse/specialty/obstetrics-gynecology) [Ophthalmic (7)](/hub/fdapulse/specialty/ophthalmic)

### Browse by record type by specialty

[Radiology devices: recent FDA 510(k) clearances (56)](/hub/fdapulse/specialty_type/radiology--510k-clearances) [Orthopedic devices: recent FDA 510(k) clearances (53)](/hub/fdapulse/specialty_type/orthopedic--510k-clearances) [Cardiovascular devices: recent FDA 510(k) clearances (52)](/hub/fdapulse/specialty_type/cardiovascular--510k-clearances) [General & Plastic Surgery devices: recent FDA 510(k) clearances (44)](/hub/fdapulse/specialty_type/general-plastic-surgery--510k-clearances) [Dental devices: recent FDA 510(k) clearances (32)](/hub/fdapulse/specialty_type/dental--510k-clearances) [Gastroenterology & Urology devices: recent FDA 510(k) clearances (27)](/hub/fdapulse/specialty_type/gastroenterology-urology--510k-clearances) [Neurology devices: recent FDA 510(k) clearances (23)](/hub/fdapulse/specialty_type/neurology--510k-clearances) [Microbiology devices: recent FDA 510(k) clearances (21)](/hub/fdapulse/specialty_type/microbiology--510k-clearances) [Clinical Chemistry devices: recent FDA 510(k) clearances (15)](/hub/fdapulse/specialty_type/clinical-chemistry--510k-clearances) [General Hospital devices: recent FDA 510(k) clearances (14)](/hub/fdapulse/specialty_type/general-hospital--510k-clearances) [Anesthesiology devices: recent FDA 510(k) clearances (12)](/hub/fdapulse/specialty_type/anesthesiology--510k-clearances) [Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9)](/hub/fdapulse/specialty_type/obstetrics-gynecology--510k-clearances) [Ophthalmic devices: recent FDA 510(k) clearances (7)](/hub/fdapulse/specialty_type/ophthalmic--510k-clearances)

## 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](/feed/fdapulse.xml)

## Often used together

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