Recall Ledger

Halyard IV START KIT NON-STERILE recall (AVID Medical, Inc.)

Medical deviceClass IOngoing

Summary: AVID Medical, Inc. is recalling Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.. Reason: Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.

What is being recalled

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.

Why

Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.

How serious is it

Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.

Where it was sold

US Nationwide distribution.

How to tell if yours is affected

Kit Model Number: KRIV26-02. UDI-DI: 10809160460481. Lot Number: 1658437. Expiration Date: 1/31/2027

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-3194-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass I
StatusOngoing
Recall startedJuly 22, 2026
ReportedSeptember 30, 2026
CompanyAVID Medical, Inc.
Company locationToano, VA, United States
Initiated byVoluntary: Firm initiated
Quantity288 kits (6 cases)

More recalls from AVID Medical, Inc. · all medical device recalls · recalls from July 2026

Official FDA record