Lower riskMedical device recall · FDA · Published November 6, 2017
Owen Mumford Unifine Pentips 5mm x 31G Pen Needles: Water Risk Compromises Sterility
Owen Mumford recalls 100-count packs of Unifine Pentips 5mm x 31G pen needles due to potential water exposure causing discoloration and sterility compromise. Affected units have specific UPC and batch numbers.
Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
Take action
Contact the company
📍Recalling firmOwen Mumford USA, Inc.1755 W Oak Commons Ct · Marietta, GA 30062-2280
✎ GovInfoNow plain-language explainer
Owen Mumford is recalling 100-count packs of Unifine Pentips 5mm x 31G pen needles because water in the packaging might compromise their sterility, which could lead to infections if used. This risk is specific to the packaging design and not the needles themselves. Read more at govinfonow.com/recall/72597-owen-mumford-unifine-pentips-5mm-x-31g-pen-needles-water.
“Owen Mumford Unifine Pentips 5mm x 31G Pen Needles: Water Risk Compromises Sterility.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72597-owen-mumford-unifine-pentips-5mm-x-31g-pen-needles-water. Based on FDA recall #Z-0381-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0381-2018%22&limit=1).
Owen Mumford USA, Inc. recalled Unifine Pentips pen needles on Nov. 6, 2017, after the FDA said water exposure may compromise sterility. The agency announced the voluntary Class II recall.
How to tell if you have it
Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct
UPC #384703550018
Batch No. AN 3550, Lot No. 1705722.S846
Batch No. AN 3550AC, Lot No. 1705122.S929
The hazard
The FDA said the device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility, which may appear as discoloring or yellowing of the device's protective seal.
Context
GovInfoNow's records show Owen Mumford USA, Inc. has 2 other recalls on record since 2019-07-17. Other recent recalls of similar products include Arrow PSI Kits Recall (2026-04-21) and Medline Convenience Kits Recall (2026-06-12).
How to tell if you have this one
Check for UPC #384703550018 with batch numbers AN 3550, Lot 1705722.S846 or AN 3550AC, Lot 1705122.S929. The product is a 100-count pack of sterile pen needles for medical injections.
Brand
Owen Mumford
Product
Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles
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
US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH NJ, NY, OH, OK, PA, TN, NX, UT, VA, VT, WA, WV
Recall number
Product, codes & lots
Quantity
Z-0381-2018
Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.; UPC #384703550018: Batch No. AN 3550, Lot No. 1705722.S846; Batch No. AN 3550AC, Lot No. 1705122.S929.
2,660 cartons (266,000 pen needles)
Z-0382-2018
Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.; UPC #384701150012: Batch No. AN 1150, Lot No.1705711.T098; Batch No. 1150REC, Lot No. 1705722.T099; Batch No. AN 1150HEB, Lot No. 1705722.T100.
708 cartons (21,240 pen needles)
Based on the official FDA remedy
What to do — step by step
Check Packaging Seal
Look for discoloration or yellowing on the protective seal of the packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 27 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH NJ, NY, OH, OK, PA, TN, NX, UT, VA, VT, WA, WV” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Utah, Vermont, Virginia, Washington, West Virginia.
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0381-2018 (November 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0381-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 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.