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
This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.
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-0282-2027
- 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
- 56 kits
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Model/Catalog Number: SOAH31. UDI-DI: 10809160512890. Lot Code: Lot Number: 1689215. Expiration Date: 11/06/2026.
Products covered by this recall
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.
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.
- 11/06/2026
Model or item number
On the rating label, the box or the instruction sheet.
- SOAH31
- SOAH31. 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. — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.
- Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
- Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
- 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.
Refunds and replacements
With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.
- Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
- For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
- If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
- If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.
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 11/06/2026; model number SOAH31, SOAH31. 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?
Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
Where was the recalled product sold?
It was distributed nationwide.
Related recalls
-
Class II · 5 days ago
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…
-
Class II · 19 days ago
AVID Medical, Inc. Robotic Prostatectomy Pack recall: Product may be potentially contaminated with a lubricant used during
Product may be potentially contaminated with a lubricant used during the manufacturing process.
-
Class II · 19 days ago
AVID Medical, Inc. Adult Heart Tray Shands Jacks recall: Product may be potentially contaminated with a lubricant used during
Product may be potentially contaminated with a lubricant used during the manufacturing process.
-
Class II · 19 days ago
AVID Medical, Inc. Craniotomy Pack recall: Product may be potentially contaminated with a lubricant used during
Product may be potentially contaminated with a lubricant used during the manufacturing process.
-
Class II · 19 days ago
AVID Medical, Inc. Urology Major recall: Product may be potentially contaminated with a lubricant used during
Product may be potentially contaminated with a lubricant used during the manufacturing process.
-
Class II · 19 days ago
AVID Medical, Inc. Davinci Trucustom Bundle recall: Product may be potentially contaminated with a lubricant used during
Product may be potentially contaminated with a lubricant used during the manufacturing process.