Agency classClass IIOur severity:High FDA (Drugs)·D-1675-2012·Announced 2012-09-26

Dukal Recalls ZEE Antiseptic Wipes Due to Microbial Contamination

Dukal Corp. is recalling ZEE Antiseptic Wipes due to contamination with Burkholderia cepacia. The affected products were distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen (Burkholderia cepacia) in a medical product, which fits the rubric criteria for 'High' severity (high-risk pathogens without reported illness).

Plain-English summary

Dukal Corp. is recalling ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter. The product is supplied in boxes of 10, 50, and 100 wipes and was distributed by ZEE MEDICAL, INC., Irvine, CA. The recall covers products shipped since July 02, 2009, with specific lot numbers listed in the agency's structured data.

The recall was initiated because of microbial contamination of the non-sterile product with Burkholderia cepacia. The distribution pattern for these products is nationwide.

Consumers should stop using the affected ZEE Antiseptic Wipes and follow the instructions provided by the recalling firm or the FDA for disposal or return.

The recalled product

Product: ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA
Manufacturer: Dukal Corp.
Category: Medical Device — First Aid / Antiseptic
Hazard: microbial-contamination
infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Antiseptic wipes shipped since July 02
2009. Lots: JT14509
JT15209
JT20609
JT20909
JT23709
JT27809
JT32809
JT00710
JT15810
JT18310
JT18810
JT23210
JT25810
JT27610
JT31510
JT35610
JT35911
JT04811
JT05311

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Dukal Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Dukal Corp.

See all →

Moderate
Dukal Blue Burn Sheets Recalled Due to Shredded Product in Cartons
FDA (Devices) · 2017-12-20
High
Dukal BZK Swabs Recalled for Burkholderia cepacia Contamination
FDA (Drugs) · 2012-09-26

Same hazard · microbial contamination