Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels
Cardinal Health is recalling specific lots of AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
What this means for you
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 risk-of-harm product (surgical gowns) with unknown contamination levels, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Cardinal Health is recalling 7,659,634 units of AAMI 3 non-reinforced surgical gowns (Item Code ASG9545). The recall affects specific lots manufactured in 2018 and 2019, identified by specific lot number formats and facility codes. The gowns were distributed worldwide, including in the United States, Puerto Rico, Guam, and various international locations.
The recall was initiated because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The source text does not specify the exact nature of the contamination or report any specific illnesses or injuries associated with the product.
Healthcare facilities and consumers should check their inventory for the affected lot numbers and stop using the recalled gowns. The source text does not provide specific instructions for disposal or return, but users should follow standard protocols for handling recalled medical devices.
The recalled product
- Product
- AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545
- 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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