Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels
Cardinal Health is recalling specific lots of AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
The agency’s classification
FDA (Devices): 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves unknown contamination levels (bioburden and particulates) in sterile medical devices, which poses a risk of infection or injury to patients, meeting the criteria for a Severe rating.
Plain-English summary
Cardinal Health is recalling approximately 7.7 million units of AAMI 3 FABRNF SCRUB SURG GWN XL NS surgical gowns (Item Code 91070NB). The recall affects specific lots manufactured in 2018 and 2019, identified by lot numbers ending in J or JX, or specific bulk non-sterile lot formats.
The recall was initiated because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The agency has classified this as a Class II recall, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The affected products were distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam), Canada, Australia, and various countries in the Middle East, South America, and Asia. Healthcare facilities and distributors should check their inventory for the specific lot numbers listed in the recall notice and stop using the affected gowns.
The recalled product
- Product
- AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
- Manufacturer
- Cardinal Health
- Category
- Medical Device — Surgical Gowns
- Affected units
- 7,659,634
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 (2)
- 244 or greater is affected OR " " If made in 2019
- any value is affected
Distribution
Part of a larger recall action
This product is one of 39 recalled by Cardinal Health under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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