FDAClass II · Medical device · Recall Z-2320-2026 · Recalled June 17, 2026

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves recall — BERLIN HEART GMBH

Agency report date: June 17, 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: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves
Company / brand: BERLIN HEART
Lot / serial / date codes: REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
Distribution: US Nationwide distribution in the states of MA, SC.

Agency product description and boundaries

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01

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: Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

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: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2320-2026
Brand: All BERLIN HEART recalls
Classification: Class II
Units affected: 3
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves recall status

Companies & origin

Recalling firm location: Berlin, N/A, Germany
Firm address: Wiesenweg 10, N/A, N/A

Identifying details (verbatim from the notice)

Product codes / lots: REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
Distribution: US Nationwide distribution in the states of MA, SC.
Firm notified the public via: Letter
FDA event ID: 98797
Recall initiated: April 24, 2026
FDA classified: June 5, 2026
FDA report date: June 17, 2026

Other medical device recalls from around the same time

Giraffe Warmer with Integrated Resuscitation System (iRes) recall — Datex-Ohmeda IncFDA · June 24, 2026
Giraffe Stand-alone Infant Resuscitation System recall — Datex-Ohmeda IncFDA · June 24, 2026
Design Options Spinal Tray Spinal Needle Anesthesia procedure kits recall — B Braun Medical IncFDA · June 10, 2026
Spinocan Spinal Needle procedure kits recall — B Braun Medical IncFDA · June 10, 2026
Spinal Needle procedure kits recall — B Braun Medical IncFDA · June 10, 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 ↗

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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 September 15, 2026 at 6:00 PM UTC.

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