CLASS I ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report
Halyard IV Start Kit Non-sterile recalled by Avid Medical
Avid Medical is recalling Halyard IV Start Kit Non-sterile, distributed nationwide in the US. The recall was initiated on 14 Jul 2026 and the FDA has classified it as Class I.
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-3108-2026
- FDA event ID
- 99672
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 14 Jul 2026
- FDA classified
- 14 Sep 2026
- Reported
- 23 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Jul 2026 | Recall initiated by company | |
| 14 Sep 2026 | Classified by FDA | +62 days |
| 23 Sep 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
Product as listed by the FDA
Halyard IV START KIT NON-STERILE REF: KRIV26-02
Where it was distributed
US Nationwide distribution in the state of NE.
Questions about this recall
Why was it recalled?
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
Which lots are affected?
Lot Number: 1658437 UDI: 10809160460481
Where was it sold?
US Nationwide distribution in the state of NE.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 29 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 Avid Medical
All 192| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Halyard IV Start Kit Non-sterile recalled by Avid Medical | Avid Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Halyard IV Start Kit Non-sterile recalled by Avid Medical | Avid Medical | Packaging Defects | Nationwide |
| Device | CLASS I | Halyard IV Start Kit Non-sterile recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS I | Haylard Continuous Nerve Block Tray kits recalled by Avid Medical | Avid Medical | Sterility | 4 states |
| Device | CLASS I | Haylard Basic Biopsy Tray kits recalled by Avid Medical | Avid Medical | Sterility | 4 states |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |