FDAClass I · Medical device · Recall Z-1970-2026 · Recalled May 13, 2026

Halyard CARDIAC CATH PACK kit recall — AVID Medical, Inc.

Agency report date: May 13, 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: Halyard CARDIAC CATH PACK kit
Company / brand: AVID Medical
Lot / serial / date codes: 1. Model Number: EAMC1000-05. UDI-DI (Kit Lot Numbers): 10809160377314 (1573593, 1583827, 1609541, 1609725, 1612134, 1612516, 1619132, 1623384, 1627013, 1635459, 1672306, 1675159). 2. Model Number: WAFB208-02. UDI-DI (Kit Lot Numbers): 10809160424759 (1615954, 1653009).
Distribution: US distribution to FL, IL, MO, MS, NC, NE, TX.

Agency product description and boundaries

Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.

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: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

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

Class I: most serious — reasonable probability of serious health consequences or death.

Affected product: Halyard CARDIAC CATH PACK kit

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1970-2026
Brand: AVID Medical
Classification: Class I
Units affected: 222 kits
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Halyard CARDIAC CATH PACK kit

Companies & origin

Recalling firm location: Toano, VA, United States
Firm address: 9000 Westmont Dr, 23168-9351

Identifying details (verbatim from the notice)

Product codes / lots: 1. Model Number: EAMC1000-05. UDI-DI (Kit Lot Numbers): 10809160377314 (1573593, 1583827, 1609541, 1609725, 1612134, 1612516, 1619132, 1623384, 1627013, 1635459, 1672306, 1675159). 2. Model Number: WAFB208-02. UDI-DI (Kit Lot Numbers): 10809160424759 (1615954, 1653009).
Distribution: US distribution to FL, IL, MO, MS, NC, NE, TX.
Firm notified the public via: E-Mail
FDA event ID: 98686
Recall initiated: March 13, 2026
FDA classified: May 1, 2026
FDA report date: May 13, 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 September 7, 2026 at 6:00 AM UTC. Record retrieved August 11, 2026 at 6:00 PM UTC.

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