FDAClass II · Medical device · Recall Z-2963-2026 · Recalled August 26, 2026

GETINGE Y SENSOR Module recall — Maquet Critical Care AB

Agency report date: August 26, 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: GETINGE Y SENSOR Module
Company / brand: Maquet Critical Care AB
Lot / serial / date codes: DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.
Distribution: US Nationwide distribution in the states of CA, GA, MN, NY.

Agency product description and boundaries

GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.

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: The module did not undergo electrical safety tests and functional tests during production.

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

Class II: may cause temporary or medically reversible health consequences.

Affected product: GETINGE Y SENSOR Module recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2963-2026
Brand: All Maquet Critical Care AB recalls
Classification: Class II
Units affected: 9 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

GETINGE Y SENSOR Module recall status

Companies & origin

Recalling firm location: Solna, Sweden
Firm address: Rontgenvagen 2, N/A

Identifying details (verbatim from the notice)

Product codes / lots: DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.
Distribution: US Nationwide distribution in the states of CA, GA, MN, NY.
Firm notified the public via: Letter
FDA event ID: 99439
Recall initiated: June 30, 2026
FDA classified: August 14, 2026
FDA report date: August 26, 2026

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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 ↗

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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 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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