Quest Medical Recalls Lacrimal Intubation Sets Due to Labeling Error
Quest Medical is recalling 106 units of LIS27T Lacrimal Intubation Sets because the expiration date was incorrectly printed in the manufacturing date field.
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, and the hazard is a labeling error (mis-labeling) without reported injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Quest Medical, Inc. is recalling 106 units of the LIS27T Lacrimal Intubation Set. These sterile, prescription-only devices are used in various ophthalmology procedures. The recall involves specific lots, 40905AQ and 40601C.
The recall was initiated because the expiration date was incorrectly printed in the Manufacturing Date field on both the pouch and carton labels. This labeling error could potentially lead to the use of expired medical devices.
The affected products were distributed worldwide, including nationwide in the United States and in Ireland. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected sets if found.
The recalled product
- Product
- LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.
- Manufacturer
- Quest Medical, Inc.
- Category
- Medical Device — Ophthalmology
- Hazard
- Affected units
- 106
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)
- Lot 40905AQ and 40601C
Distribution
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