Lower riskMedical device recall · FDA · Published June 18, 2019
Epimed Versa Kath Mini Kit Mislabeled - Incorrect Catheter Size
Epimed recalls Versa Kath Mini Kit with mislabeled catheter size. The kit includes a 21-gauge catheter but labels state 12-gauge. This affects medical use for epidural anesthesia.
Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
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Contact the company
📍Recalling firmEpimed International, Inc.141 Sal Landrio Dr, Crossroads Business Park · Johnstown, NY 12095-3835
✎ GovInfoNow plain-language explainer
Epimed is recalling a Versa Kath Mini Kit for epidural anesthesia that has incorrect catheter labeling. The kit includes a 21-gauge catheter but the label says it has a 12-gauge catheter. This could lead to improper medical use if the wrong catheter size is used. Read more at govinfonow.com/recall/67647-epimed-versa-kath-mini-kit-mislabeled-incorrect-catheter-size.
“Epimed Versa Kath Mini Kit Mislabeled - Incorrect Catheter Size.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/67647-epimed-versa-kath-mini-kit-mislabeled-incorrect-catheter-size. Based on FDA recall #Z-2069-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2069-2019%22&limit=1).
The FDA announced on June 18, 2019, that Epimed International, Inc. voluntarily recalled Versa-Kath Mini Kits due to mislabeled catheter sizes. The hazard involves the product's labeling stating a 12 gauge catheter is included when it actually contains a 21 gauge catheter.
How to tell if you have it
Brand: Epimed
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)
UPC/Code: 108187880213945
Lot Code: 31129344
Expiration Date: 2023-06-30
The hazard
The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
Context
GovInfoNow's records show Epimed International, Inc. has one other recall on record since February 1, 2021, specifically the Feth-R-Kath Catheter Recall dated February 1, 2021, involving a cracking coating risk. Other recent recalls of similar products include Medline Intubation Tray Recall (December 24, 2025), Medline Medical Procedure Kits (May 4, 2026), and Medline 14 Fr Suction Catheter Kits Recall (December 24, 2025).
How to tell if you have this one
Check for the product code REF 181-2112, RX, (01) on the kit. The kit includes a 21-gauge catheter but labels state 12-gauge. It was sold with lot number 31129344, expiring June 30, 2023.
Brand
Epimed
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico
Recall number
Product, codes & lots
Quantity
Z-2068-2019
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 311291155 for epidural or caudal anesthesia; Lot 31129155, Exp: 2022-12-31
200 kits
Z-2069-2019
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; Lot 31129344 Exp: 2023-06-30
98 kits
Based on the official FDA remedy
What to do — step by step
Check Labeling
Verify the catheter size on the product label; the kit should state 21-gauge but may incorrectly list 12-gauge.
Where it went and when
Where it was distributed
Distributed in 8 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, California, Florida, Idaho, New York, Oklahoma, Texas, Washington.
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2069-2019 (June 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2069-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.