CLASS II ONGOING Device recall · Reported 28 Oct 2026 · FDA Enforcement Report
Halyard Anterior Hip Pack recalled by Avid Medical
Avid Medical is recalling Halyard Anterior Hip Pack, distributed nationwide in the US. The recall was initiated on 8 Sep 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-0283-2027
- FDA event ID
- 99968
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Sep 2026
- FDA classified
- 22 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 8 Sep 2026 | Recall initiated by company | |
| 22 Oct 2026 | Classified by FDA | +44 days |
| 28 Oct 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
Where it was distributed
US Nationwide distributor in the state of Arizona.
Questions about this recall
Why was it recalled?
A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
Which lots are affected?
Model/Catalog Number: SOAH30. UDI-DI: 10809160520246. Lot Code: Lot Numbers: 1705826, 1705827. Expiration Date: 1/31/2028.
Where was it sold?
US Nationwide distributor in the state of Arizona.
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 3 Nov 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
1 other product · FDA event 99968| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Halyard Anterior Hip Pack recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
More recalls from Avid Medical
All 209| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Halyard Anterior Hip Pack recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| 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 |
Other Hip & Knee Implants recalls
All 3,118| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Halyard Anterior Hip Pack recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Hip Scope Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | TS Femoral Prep Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | Grafton" DBM and Grafton Plus" DBM contain demineralized recalled | Medtronic Sofamor Danek USA | Other Bacterial Contamination | Nationwide |
| Device | CLASS II | Grafton" DBM and Grafton Plus" DBM contain demineralized recalled | Medtronic Sofamor Danek USA | Other Bacterial Contamination | Nationwide |