Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 24, 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.
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 pro…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Owen Mumford USA, Inc. recalled Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: … - a moderate-severity action.
Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: … was recalled by Owen Mumford USA, Inc. in January 24, 2018. Reason: Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise steri…. Check the official notice for the remedy. Verify recall #Z-0382-2018 with the FDA Devices before acting.
The recall
Owen Mumford USA, Inc. issued this moderate-severity FDA Devices recall-Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise steri….
- Moderate
- severity level
- Class II
- classification
- January 24, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0382-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0382-2018) was formally reported on January 24, 2018, with the manufacturer initiating the action on November 6, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Owen Mumford USA, Inc. is listed as the recalling firm, operating out of Marietta, GA. Federal records list the affected scope as 708 cartons (21,240 pen needles).
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
708 cartons (21,240 pen needles)
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0382-2018 |
| Date reported | January 24, 2018 |
| Date initiated | November 6, 2017 |
| Recalling firm | Owen Mumford USA, Inc. |
| Firm location | Marietta, GA |
| Affected scope | 708 cartons (21,240 pen needles) |
| 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0382-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Owen Mumford USA, Inc.. Units affected: 708 cartons (21,240 pen needles).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2018. Severity: Moderate. Recall number: Z-0382-2018.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0382-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 24, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.