The AVID Medical IV start kit Class I recall covers one specific lot of kits that may contain skin-prep applicators contaminated with a fungus. In the FDA’s recall database, the product, an IV Start Kit Non-Sterile with item number KRIV26-02 and kit lot 1658437, is classified as Class 1, the agency’s most serious recall category, because using contaminated skin-prep products could cause serious infection. Hospitals and other customers are told to find the kits, quarantine them and destroy them after completing the response form. The warning applies to the listed kits and lot, not to every AVID Medical product.
This guide sets out what is affected, what the FDA says the risk is, the steps facilities are asked to take, and where the public records disagree with each other.
AVID Medical IV start kit Class I recall: key takeaways
- Product: IV Start Kit Non-Sterile, item KRIV26-02, kit lot 1658437.
- Problem: the kit contains a BD ChloraPrep Clear 1 mL applicator (BD lot 4032183) that may be contaminated with the fungus Aspergillus penicillioides.
- Class: Class 1, the FDA’s most serious recall classification.
- Action: identify and quarantine the kits, then destroy the entire kit after completing the response form.
- Injuries: as of 20 August 2026, AVID Medical had reported no serious injuries or deaths linked to the issue, according to the FDA.
Which products are affected by the AVID Medical IV start kit Class I recall
The FDA records identify the device as the IV Start Kit Non-Sterile (listed in the database as Halyard IV START KIT NON-STERILE), item number KRIV26-02, kit lot number 1658437, with UDI-DI 10809160460481. One database entry gives an expiry of 31 January 2027 and a quantity of 288 kits, or six cases of 48. The recalling firm is AVID Medical, Inc., of Toano, Virginia, which the FDA record describes as a subsidiary of Owens & Minor. The component at the centre of the recall is the BD ChloraPrep Clear 1 mL applicator from BD lot 4032183. One entry also lists a FREPP Clear 1.5 mL applicator.
What risk lies behind the AVID Medical IV start kit Class I recall
The FDA early alert says the issue involves fungal contamination that may occur under certain environmental conditions, with the contaminant identified as Aspergillus penicillioides. It warns that contamination of skin-prep products with this fungus may cause systemic infection, sepsis, illness and death. If the fungus enters a patient’s bloodstream during catheter placement, the catheter would likely need to be removed, requiring another procedure. A surgical-site infection may need medical or surgical intervention and long-term antifungal treatment. The FDA record gives the cause as packaging process control. It does not say that any patient was harmed.
What facilities should do now about the AVID Medical IV start kit Class I recall
- Check inventory immediately for kits matching KRIV26-02, lot 1658437, and quarantine them.
- Complete the recall response form.
- Destroy the entire kit. The earlier instruction to over-label and discard only the applicator no longer applies to these items.
- Distributors and resellers should notify customers and report customer quantities on the response form.
- U.S. customers with questions or quality problems can contact complaints@owens-minor.com, and adverse reactions can be reported through MedWatch.
How the AVID Medical IV start kit Class I recall unfolded
The public records give slightly different dates, which we set out rather than choose between. AVID Medical’s first notice to customers is dated 14 July in one FDA database entry and 22 July in the FDA alert and another entry. An updated customer letter is dated 18 August in one entry and 20 August in others. The response form was due on 28 August, the day the FDA published its early alert. The FDA database lists the recall for lot 1658437 as posted on 14 September 2026, classified as Class 1.
Is every KRIV26-02 kit in the AVID Medical IV start kit Class I recall affected?
No. The Class 1 entries name kit lot 1658437. The FDA database also lists other lots of the same item, including 1658438, 1685838, 1699753 and 1706455, under separate Class 2 entries. We are not saying those lots are safe, and facilities should follow the FDA entries and AVID Medical’s instructions for each lot. What the records show is that the Class I classification attaches to the lot named in this story, so a warning should not be stretched to other products.
What the AVID Medical IV start kit Class I recall classification means
Under FDA’s recall definitions, a Class I recall is the most serious category, used when there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death. It describes the seriousness of the potential hazard, not how many people have been harmed.
What patients should know
The FDA pages we reviewed give instructions to facilities and distributors, not to patients. Patients do not need to inspect kits. Anyone worried about a recent IV or catheter procedure should speak to their clinician, particularly if they develop fever or a problem at the insertion site.
Risks and caveats on the AVID Medical IV start kit Class I recall
- Records differ on dates and distribution: one entry says the 288 kits were distributed in Nebraska, another says nationwide.
- We have not seen the response form or AVID Medical’s customer letters, only the FDA’s summaries.
- No reported injuries is not proof that none occurred.
- Lot numbers must be checked against the FDA entries by the facility.
In our assessment, the practical message is narrow and clear: check for lot 1658437, quarantine, destroy the whole kit, and do not extrapolate. The FDA recall database entry is the place to confirm lot details. See also Sri Lanka Pharmaceutical Manufacturing: Bold $20M Push. More is in our medical device section.
What to watch next on the AVID Medical IV start kit Class I recall
- Any further FDA updates to the early alert or database entries.
- Clarification of the quantities and where the kits were sent.
- Any adverse event reports.
- Whether the status of the recall changes from open.
Frequently asked questions
Which lot is covered by the AVID Medical IV start kit Class I recall?
Kit lot 1658437 of item KRIV26-02, containing BD ChloraPrep Clear applicators from BD lot 4032183.
What fungus is involved?
Aspergillus penicillioides, according to the FDA.
Should the kits be returned or destroyed?
The FDA says to destroy the entire kit after completing the response form.
Have injuries been reported?
As of 20 August 2026, AVID Medical had reported no serious injuries or deaths.
How we reported this: we relied on the FDA early alert and the FDA recall database entries. Last updated: 16 October 2026. This article is news reporting and not medical advice.