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
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-3011-2026
- 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.
Questions about this recall
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: 1649519 UDI: 10809160457887
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 99527This product is part of a recall event; the main page for the event is Halyard Total Joint recalled by AVID Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Halyard Total Joint recalled by AVID Medical | Avid Medical | Foreign Material | Nationwide | |
| CLASS II | Halyard Davinci Trucustom Bundle containing Tray Foley W/Statlock recalled | Avid Medical | Foreign Material | Nationwide | |
| CLASS II | Halyard Total Joint recalled by AVID Medical | Avid Medical | Foreign Material | Nationwide | |
| CLASS II | Halyard Total Joint recalled by AVID Medical | Avid Medical | Foreign Material | Nationwide | |
| CLASS II | Halyard Total Joint recalled by AVID Medical | Avid Medical | Foreign Material | Nationwide | |
| CLASS II | Halyard Total Joint recalled by AVID Medical | Avid Medical | Foreign Material | Nationwide |
More recalls from Avid Medical
All 207| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |