CLASS II ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report
Halyard, ENT PACK recalled by AVID Medical
Avid Medical is recalling Halyard, ENT PACK, distributed nationwide in the US. The recall was initiated on 4 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2530-2025
- FDA event ID
- 97452
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Aug 2025
- FDA classified
- 5 Sep 2025
- Reported
- 17 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 4 Aug 2025 | Recall initiated by company | |
| 5 Sep 2025 | Classified by FDA | +32 days |
| 17 Sep 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for open header bag seals, compromising sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Where it was distributed
US Nationwide distribution in the state of Florida.
Questions about this recall
Why was it recalled?
Potential for open header bag seals, compromising sterility.
Which lots are affected?
Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218, Expiration Date: 7/17/2027.
Where was it sold?
US Nationwide distribution in the state of Florida.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97452| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Halyard, Cpt Basic IR Pack recalled by AVID Medical | Avid Medical | Sterility | Nationwide |
More recalls from Avid Medical
All 192| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Halyard IV Start Kit Non-sterile recalled by Avid Medical | Avid Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Halyard IV Start Kit Non-sterile recalled by Avid Medical | Avid Medical | Packaging Defects | Nationwide |
| Device | CLASS I | Halyard IV Start Kit Non-sterile recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS I | Haylard Continuous Nerve Block Tray kits recalled by Avid Medical | Avid Medical | Sterility | 4 states |
| Device | CLASS I | Halyard IV Start Kit Non-sterile recalled by Avid Medical | Avid Medical | Other | Nationwide |
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| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |