FDAClass III · Medical device · Recall Z-0111-2027 · Recalled October 14, 2026

BeneVision Series Telemetry Monitor recall — Mindray DS USA, Inc.

Agency report date: October 14, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: BeneVision Series Telemetry Monitor
Company / brand: Mindray DS USA
Lot / serial / date codes: Part numbers of BeneVision Series Telemetry Monitor Operator's Manuals: 1. BeneVision TMS60 (TD60)/TM80 (no alarms) Operator's Manual up to and including revision 5.0; Part No. 046-011232-00 2. BeneVision TM70 Telemetry Monitor Operator's Manual up to and including revision 4.0; Part No. 046-019362-00 3. TM80 Telemetry Monitor Operator's Manual up to and including revision 9.0; Part No. 046-012662-00 4. TMS60 Telemetry Monitoring System Operator's Manual up to and including revision 4.0; Part No. 046-007056-00
Distribution: Worldwide - Nationwide and the country of Canada.

Agency product description and boundaries

BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class III: not likely to cause adverse health consequences.

Affected product: BeneVision Series Telemetry Monitor recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-0111-2027
Brand: All Mindray DS USA recalls
Classification: Class III
Units affected: 29,737 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

BeneVision Series Telemetry Monitor recall status

Companies & origin

Recalling firm location: Mahwah, NJ, United States
Firm address: 800 Macarthur Blvd, N/A, 07430-2001

Identifying details (verbatim from the notice)

Product codes / lots: Part numbers of BeneVision Series Telemetry Monitor Operator's Manuals: 1. BeneVision TMS60 (TD60)/TM80 (no alarms) Operator's Manual up to and including revision 5.0; Part No. 046-011232-00 2. BeneVision TM70 Telemetry Monitor Operator's Manual up to and including revision 4.0; Part No. 046-019362-00 3. TM80 Telemetry Monitor Operator's Manual up to and including revision 9.0; Part No. 046-012662-00 4. TMS60 Telemetry Monitoring System Operator's Manual up to and including revision 4.0; Part No. 046-007056-00
Distribution: Worldwide - Nationwide and the country of Canada.
Firm notified the public via: Letter
FDA event ID: 99828
Recall initiated: August 31, 2026
FDA classified: October 7, 2026
FDA report date: October 14, 2026

Other medical device recalls from around the same time

VentStar Resus Neo recall — Draeger, Inc.FDA · October 7, 2026
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED recall — Medline Industries, LPFDA · October 7, 2026
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories recall — Medline Industries, LPFDA · October 7, 2026
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 recall — Boston Scientific CorporationFDA · September 30, 2026
Halyard IV START KIT NON-STERILE recall — AVID Medical, Inc.FDA · September 30, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.

Report a data error on this page