RecallRadar
FDA · Medical devicesClass I

AVID Medical, Inc. medical device recall: Halyard IV START KIT NON-STERILE REF: KRIV26-02

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
99672
Recall initiated
Jul 14, 2026
Classified by FDA
Sep 14, 2026
Posted in Enforcement Report
Sep 23, 2026
Recalling firm
AVID Medical, Inc.
Firm location
Toano, VA, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
E-Mail
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.

View the official FDA record ↗

Reason for recall

Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are 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 14, 2026. FDA classified it 62 days later, on Sep 14, 2026. Distribution reported by FDA: US Nationwide distribution in the state of NE. AVID Medical, Inc. has 28 recalls in our records.

Recalled products (1)

  • Z-3108-2026 Class I Ongoing

    Halyard IV START KIT NON-STERILE REF: KRIV26-02

    Codes / lots: Lot Number: 1658437 UDI: 10809160460481

    Quantity: 288 units

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 99672
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.

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