CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
Halyard, Drape Pack recalled by AVID Medical
Avid Medical is recalling Halyard, Drape Pack, distributed nationwide in the US. The recall was initiated on 30 Apr 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-2409-2026
- FDA event ID
- 99021
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Apr 2026
- FDA classified
- 11 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 30 Apr 2026 | Recall initiated by company | |
| 11 Jun 2026 | Classified by FDA | +42 days |
| 17 Jun 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
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
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, Drape Pack. Kit Code: LMDP36-01.
Where it was distributed
US Nationwide distribution in the state of Iowa.
Questions about this recall
Why was it recalled?
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Which lots are affected?
Kit Code: LMDP36-01.UDI-DI: 10809160479148. Lot Number: LMDP36-01. Expiration Date: 9/10/2028
Where was it sold?
US Nationwide distribution in the state of Iowa.
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
3 other products · FDA event 99021This product is part of a recall event; the main page for the event is Halyard, Towel Six Pack recalled by AVID Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Halyard, Towel Six Pack recalled by AVID Medical | Avid Medical | Sterility | Nationwide | |
| CLASS II | Halyard, Pain Pack recalled by AVID Medical | Avid Medical | Sterility | Nationwide | |
| CLASS II | Halyard, Eye Bag Pack recalled by AVID Medical | Avid Medical | Sterility | 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 |