Food, drugs, devices › AVID Medical, Inc.
Device recall: Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
AVID Medical, Inc. (Toano, VA) initiated this device recall on 13 Mar 2026; FDA lists 10 product records under event 98686, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 12% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. AVID Medical, Inc. has 24 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
AVID Medical, Inc., Toano, VA.
Reason for recall
"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."
Distribution
"US distribution to FL, IL, MO, MS, NC, NE, TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1970-2026 | Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02. | 222 kits | Class I | Ongoing | 13 May 2026 |
| Z-1971-2026 | Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36. | 180 kits | Class I | Ongoing | 13 May 2026 |
| Z-1972-2026 | Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05. | 6,956 kits | Class I | Ongoing | 13 May 2026 |
| Z-1973-2026 | Halyard CATH LAB kit. Model Number: SACL75AM. | 228 kits | Class I | Ongoing | 13 May 2026 |
| Z-1974-2026 | Halyard CATH LAB kit. Model Number: SACL75-01. | 172 kits | Class I | Ongoing | 13 May 2026 |
| Z-1975-2026 | Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05. | 2,932 kits | Class I | Ongoing | 13 May 2026 |
| Z-1976-2026 | Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01. | 204 kits | Class I | Ongoing | 13 May 2026 |
| Z-1977-2026 | Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02. | 6,052 kits | Class I | Ongoing | 13 May 2026 |
| Z-1978-2026 | Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15. | 2,392 kits | Class I | Ongoing | 13 May 2026 |
| Z-1979-2026 | Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029. | 75 kits | Class I | Ongoing | 13 May 2026 |
Context
Other enforcement events for AVID Medical, Inc.
All 24 events for AVID Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution to FL, IL, MO, MS, NC, NE, TX."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.