FDA recall, , Moderate risk
Halyard Arthroscopy Pack
The Halyard Arthroscopy Pack is mislabeled as "Extremity" instead of "Arthroscopy Pack."
Summary by Recall Canary from the FDA notice
What happened
AVID Medical, Inc., of Toano, Virginia, voluntarily recalled the Halyard Arthroscopy Pack because the shelf label of the kit is mislabeled as "Extremity" instead of "Arthroscopy Pack." The firm initiated the recall on September 8, 2026, and the FDA added it to the Enforcement Report and classified it on November 5, 2026.
The recalled kits were distributed in Texas. Customers were notified by e-mail. The recall affects 17 kits.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Halyard Arthroscopy Pack
- Model number
- SAMM014-21
- UDI-DI
- 10809160515600
- Lot code
- 1698318
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
US Nationwide distribution in the state of Texas.
- Recalled by
- AVID Medical, Inc.Toano, Virginia
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 99964
- Recall number
- Z-0358-2027
- Quantity recalled
- 17 kits
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
All recalls from AVID Medical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
AVID Medical began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
