CLASS II ONGOING Device recall · Reported 10 Sep 2025 · FDA Enforcement Report
Orthopedic Pack recalled by O&m Halyard
O&M Halyard is recalling Orthopedic Pack, distributed nationwide in the US. The recall was initiated on 17 Jul 2025 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-2520-2025
- FDA event ID
- 97394
- Recalling firm
- O&M Halyard, Alpharetta, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jul 2025
- FDA classified
- 4 Sep 2025
- Reported
- 10 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 17 Jul 2025 | Recall initiated by company | |
| 4 Sep 2025 | Classified by FDA | +49 days |
| 10 Sep 2025 | 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
Surgical drape packs may have open seals, which may compromise the sterility of the product.
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
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Where it was distributed
Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.
Questions about this recall
Why was it recalled?
Surgical drape packs may have open seals, which may compromise the sterility of the product.
Which lots are affected?
Model/UDI-DI/Lot(expiration): 88041-12/30680651880414/AC2424601B9(09/02/2029), 77165-06/30680651771651/AC2424902B(09/05/2029)
Where was it sold?
Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.
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.
More recalls from O&M Halyard
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&M Halyard | Other | Nationwide |
| Device | CLASS II | Halyard Laparotomy Pack recalled by O&m Halyard | O&M Halyard | Sterility | Nationwide |
| Device | CLASS II | Soft Touch II Surgical Mask, Blue-Disposable surgical mask recalled | O&M Halyard | Packaging Defects | Nationwide |
| Device | CLASS II | Procedure Mask with SO SOFT* Earloops recalled by O&m Halyard | O&M Halyard | Packaging Defects | Nationwide |
| Device | CLASS III | Halyard Surgical Hood, Universal Size, Blue recalled by O&m Halyard | O&M Halyard | Labeling Errors | Nationwide |
Other Hip & Knee Implants recalls
All 3,110| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |
| Device | CLASS II | Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled | Howmedica Osteonics | Other | Nationwide |