AVID Medical, Inc. Halyard Anterior HIP Pack. Model/ recall: A non-sterile component was piggybacked and incorrectly placed outside
A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
The hazard: Sterility or particulate concern
Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.
What the notice says: A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.
Symptoms and when to call a doctor
Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.
This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.
Recall details
- Recall number
- Z-0283-2027
- Published
- October 28, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- AVID Medical, Inc.
- Product type
- Medical devices
- Units affected
- 80 kits
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Model/Catalog Number: SOAH30. UDI-DI: 10809160520246. Lot Code: Lot Numbers: 1705826, 1705827. Expiration Date: 1/31/2028.
Products covered by this recall
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
Check your product
The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
Best-by / use-by date
Printed beside the lot code, not on the price sticker.
- 1/31/2028
Model or item number
On the rating label, the box or the instruction sheet.
- SOAH30
- SOAH30. UDI-DI
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Sterility
AVID Medical, Inc. — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.
- Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
- If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
- Report any infection or reaction you think the product caused to FDA MedWatch.
- Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
What the company owes you
A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.
- The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
- Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
- Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
- Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.
Company contact: AVID Medical, Inc. — 9000 Westmont Dr, Toano, VA, 23168-9351
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was AVID Medical, Inc. medical devices recalled?
A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications. A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: best-by date 1/31/2028; model number SOAH30, SOAH30. UDI-DI. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
Can I get my money back?
The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
Where was the recalled product sold?
It was distributed nationwide.
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