CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report

Halyard Total Joint recalled by AVID Medical

AVID Medical is recalling Halyard Total Joint, distributed nationwide in the US. The recall was initiated on 9 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Lot Number: 1632948 UDI: 10809160423578

Quantity recalled63 kits

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-3006-2026
FDA event ID: 99527
Recalling firm: AVID Medical, Toano, VA
Classification: Class II
Status: Ongoing
Recall initiated: 9 Jul 2026
FDA classified: 21 Aug 2026
Reported: 2 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

9 Jul 2026	Recall initiated by company
21 Aug 2026	Classified by FDA	+43 days
2 Sep 2026	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

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

Where it was distributed

US Nationwide distribution in the states of MS, TX.

Nationwide Mississippi Texas

Questions about this recall

Is Halyard Total Joint recalled?

Yes. AVID Medical recalled Halyard Total Joint on 9 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-3006-2026.

Why was it recalled?

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Which lots are affected?

Lot Code: Lot Number: 1632948 UDI: 10809160423578

Where was it sold?

US Nationwide distribution in the states of MS, TX.

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from AVID Medical

All 184

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	AVID Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	AVID Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	AVID Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Halyard Total Joint recalled by AVID Medical	AVID Medical	Foreign Material	Nationwide

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16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
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16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide