AVID Medical, Inc. Halyard Total Joint Model/ recall: Labeling Deficiency: The medical kit labeling fails to identify
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
The hazard: Device safety concern
This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.
What the notice says: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-3008-2026
- Published
- September 2, 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
- 78 kits
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Lot Code: Lot Number: 1654575 UDI: 10809160457887
- UPC codes
- 10809160457887
Products covered by this recall
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Check your product
The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 10809160457887
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 Device
AVID Medical, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
Replacements, repairs and reimbursement
Device remedies run through the supply chain, so the route depends on who sold you the unit.
- Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
- If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
- Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
- Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.
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?
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 10809160457887. 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?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
Where was the recalled product sold?
It was distributed nationwide.
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