Epimed Versa-Kath Mini Kit Recalled for Incorrect Catheter Size Labeling
Epimed International is recalling 98 Versa-Kath Mini Kits because the labeling incorrectly states the kit contains a 12-gauge catheter, while it actually contains a 21-gauge catheter.
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 minor labeling error regarding catheter size without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Epimed International, Inc. is recalling 98 units of the Versa-Kath Mini Kit, REF 181-2112, Lot 31129344. The recall is due to a labeling error where the product packaging states that the kit includes a 12-gauge catheter, but the kit actually contains a 21-gauge catheter.
The affected kits are sterile epidural or caudal anesthesia kits that include a plastic L.O.R Syringe. The distribution pattern includes the US states of California, Florida, Oklahoma, Arkansas, Washington, Texas, Idaho, and New York, as well as South Africa and Mexico.
Healthcare providers and consumers should stop using the affected kits and contact Epimed International for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia
- Manufacturer
- Epimed International, Inc.
- Category
- Medical Device — Anesthesia Kits
- Hazard
- Affected units
- 98
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 31129344 Exp: 2023-06-30
Distribution
Part of a larger recall action
This product is one of 2 recalled by Epimed International, Inc. 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Epimed International, Inc.
See all →- HighEpimed Feth-R-Kath Catheter Recalled for Coating Deterioration
FDA (Devices) · 2021-03-24
- ModerateEpimed Versa-Kath Mini Kit Recalled for Incorrect Catheter Size Labeling
FDA (Devices) · 2019-07-31
- HighEpimed 15 g R.K. Epidural Needle Recall for Catheter Coating Risk
FDA (Devices) · 2016-11-09
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- ModerateGore Viabil Short Wire Biliary Endoprosthesis Recalled for Incorrect Length Labeling
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- HighEpimed Feth-R-Kath Catheter Recalled for Coating Deterioration
FDA (Devices) · 2021-03-24
- HighFDA Recalls Catheter Drainage Kits With Wrong Needle Size
FDA (Devices) · 2022-06-29
- HighEPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
FDA (Devices) · 2021-04-07
- HighEPIX Therapeutics DiamondTemp Catheter Recalled for Labeling Errors
FDA (Devices) · 2021-04-07
- HighEdwards PediaSat Oximetry Catheter Set recalled for potential internal leaks
FDA (Devices) · 2021-08-18
- HighNEO-KATH Epidural Catheter Set recalled for potential stylet protrusion
FDA (Devices) · 2021-08-25