Epimed RX-2 Epidural Needle Recall: Sterility Risk from Partial Seal
Epimed recalls 10-unit sterile epidural needles due to potential partial seal failure, risking infection. Affected items have specific lot numbers and are for medical use only.
Stop using this now
Potential for partially incomplete seal of product, impacting sterility.
Contact the company
What happened, in plain English
Epimed International is recalling 10 sterile epidural needles that may have a partial seal failure, increasing infection risk during medical procedures. Healthcare providers using these needles should stop using them immediately. Read more at govinfonow.com/recall/73360-epimed-rx-2-epidural-needle-recall-sterility-risk-from-partial.
Source Summary by GovInfoNow · govinfonow.com/recall/73360-epimed-rx-2-epidural-needle-recall-sterility-risk-from-partial · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0087-2018
Cite this page
“Epimed RX-2 Epidural Needle Recall: Sterility Risk from Partial Seal.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73360-epimed-rx-2-epidural-needle-recall-sterility-risk-from-partial. Based on FDA recall #Z-0087-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0087-2018%22&limit=1).
Why it’s dangerous
The needles may not seal properly, allowing contaminants to enter the sterile product. This could lead to infections during medical procedures if the needles are used without proper sterility.
Who’s affected
Healthcare providers who purchased or use the recalled needles for epidural procedures are most at risk. Patients receiving these needles during medical treatment could face infection.
How to tell if you have this one
Check for the lot number 12168200 on the packaging. The product is a sterile epidural needle set with specific dimensions and features for medical use only.
- Brand
Epimed International- Category
Medical device
All 3 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
Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0087-2018 | RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter; Lot No. 12168200; Ref No. 107-1416. | 500 units |
| Z-0088-2018 | COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile; Lot No. 12608201; Ref No. 117-2260. | 300 units |
| Z-0089-2018 | TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only; Lot No. 12358202; Ref No. 125-2035T. | 263 units |
What to do — step by step
Stop Using Now
Immediately stop using the recalled needles if you have them.
Where it went and when
Where it was distributed
Distributed in 13 states, and outside the U.S.
FDA distribution: “Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, California, Indiana, Iowa, Kentucky, Louisiana, Michigan, New York, Ohio, Oregon, Tennessee, Texas, Washington.
Recall timeline
FDA terminated this recall 5.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0087-2018 (July 24, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0087-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 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.