LOM Disposable Surgical Gowns Recalled for Labeling and Standards Issues
Thread Counsel Inc is recalling LOM Disposable Surgical Gowns due to missing labeling and potential non-compliance with FDA standards.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes labeling errors and potential non-compliance without reporting specific injuries or hospitalizations, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Thread Counsel Inc dba Laws of Motion is recalling approximately 2.4 million units of LOM Disposable Surgical Gowns/Medical Gowns, Single-Use. The recall was initiated because the medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns.
The affected products are identified by Lots 1-47. These gowns were distributed to accounts in New York. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Consumers and healthcare facilities should stop using the affected gowns and contact the recalling firm for instructions on return or disposal. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
- Manufacturer
- THREAD COUNSEL INC DBA LAWS OF MOTION
- Category
- Medical Device — Surgical Gowns
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 (1)
- Lots 1 -47
Distribution
Distributed in 1 state:
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