Lower riskMedical device recall · FDA · Published August 4, 2025
AVID Medical Halyard ENT Pack (JACK421-04) May Have Compromised Sterility
AVID Medical recalls ENT packs with model JACK421-04 due to potential open header bag seals that could compromise sterility. Affected units were sold from 2021 to 2027.
“AVID Medical Halyard ENT Pack (JACK421-04) May Have Compromised Sterility.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51698-avid-medical-halyard-ent-pack-jack421-04-may-have-compromised. Based on FDA recall #Z-2530-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2530-2025%22&limit=1).
The FDA announced on Aug. 4, 2025, that AVID Medical, Inc. is recalling Halyard ENT PACK convenience kits (Model JACK421-04) due to potential open header bag seals that compromise sterility. Owners should contact the company for a refund.
How to tell if you have it
Brand: AVID Medical
Product: Halyard, ENT PACK Convenience kit
Model Number: JACK421-04
UDI: 10809160462973
Lot Number: 1647218
Expiration Date: 7/17/2027
Distribution: US Nationwide, including Florida
Units affected: 57
The hazard
The recall cites the potential for open header bag seals, which compromises sterility. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show AVID Medical, Inc. has 23 other recalls on record since June 22, 2017. Other recent recalls of similar products include AVID Medical Haylard Basic Biopsy Tray Recall (Aug. 10, 2026), AVID Medical Halyard IV Start Kit Recall (July 22, 2026) regarding sterility risk, and another AVID Medical Halyard IV Start Kit Recall (July 22, 2026) regarding open seal risk. Other recent recalls of similar products include Medline Surgical Packs Recall (Jan. 7, 2026) involving calibration issues affecting sterility, and Alcon Custom Pak Sterility Risk (Nov. 24, 2025) due to incomplete seals.
How to tell if you have this one
Check for model number JACK421-04 on the pack. Units were sold from 2021 to 2027 with lot number 1647218 and expiration date 7/17/2027.
Brand
AVID Medical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the state of Florida.
Recall number
Product, codes & lots
Quantity
Z-2530-2025
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.; Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218, Expiration Date: 7/17/2027.
57 units
Z-2531-2025
Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.; Model Number: 1646381. UDI: 10809160363256. Lot Number: 1646381. Expiration Date: 1/31/2028.
228 units
Based on the official FDA remedy
What to do — step by step
Check Packaging Seals
Look for open or damaged header bag seals on the pack.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of Florida.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2530-2025 (August 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2530-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.