Epimed Recalls TUOHY Epidural Needles Due to Potential Sterility Seal Issues
Epimed International is recalling 263 units of TUOHY Epidural Needles because a partially incomplete seal could impact the product's sterility.
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 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 medical device with a potential sterility breach, which poses a risk of harm (infection) even though no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Epimed International is recalling 263 units of TUOHY Epidural Needles, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only. The recall is due to a potential for a partially incomplete seal of the product, which could impact its sterility.
The affected product is identified by Lot No. 12358202 and Ref No. 125-2035T. The recall covers units distributed domestically in Arkansas, California, Iowa, Indiana, Kentucky, Louisiana, Michigan, New York, Ohio, Oregon, Tennessee, Texas, and Washington. The product was also distributed in Canada, the Czech Republic, Germany, and Turkey.
Healthcare providers and consumers should stop using the affected needles and contact Epimed International for further instructions or a return.
The recalled product
- Product
- TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
- Manufacturer
- Epimed International
- Category
- Medical Device — Needles
- Affected units
- 263
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)
- Lot No. 12358202
- Ref No. 125-2035T.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Epimed International 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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