AVID Medical, Inc. medical device recall: Halyard IV START KIT NON-STERILE
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99761
- Recall initiated
- Jul 22, 2026
- Classified by FDA
- Sep 23, 2026
- Posted in Enforcement Report
- Sep 30, 2026
- Recalling firm
- AVID Medical, Inc.
- Firm location
- Toano, VA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jul 22, 2026. FDA classified it 63 days later, on Sep 23, 2026. Distribution reported by FDA: US Nationwide distribution. AVID Medical, Inc. has 28 recalls in our records.
Recalled products (1)
Z-3194-2026 Class I Ongoing
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.
Codes / lots: Kit Model Number: KRIV26-02. UDI-DI: 10809160460481. Lot Number: 1658437. Expiration Date: 1/31/2027
Quantity: 288 kits (6 cases)
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 99761
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.