Owen Mumford Recalls Unifine Pentips Due to Potential Sterility Compromise
Owen Mumford USA is recalling Unifine Pentips pen needles because water exposure may have compromised sterility. Users should check for discoloration or yellowing of the protective seal.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility may be compromised, posing a risk of infection. Per the rubric, this is classified as High (Score 3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Owen Mumford USA, Inc. is recalling 2,660 cartons (266,000 units) of Unifine Pentips 5mm x 31G pen needles. These sterile, single-use needles are intended for the subcutaneous injection of drugs from pen injectors. The recall is due to a potential compromise of sterility caused by water exposure in the end-user packaging.
The affected products are identified by UPC #384703550018. Specific batch and lot numbers include Batch No. AN 3550, Lot No. 1705722.S846, and Batch No. AN 3550AC, Lot No. 1705122.S929. The products were distributed nationwide 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, and WV.
Consumers and healthcare providers should inspect the packaging for signs of water exposure, which may appear as discoloring or yellowing of the device's protective seal. If these signs are present, the device should not be used, as exposure to liquid may have compromised the sterility of the needles.
The recalled product
- Product
- 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.
- Manufacturer
- Owen Mumford USA, Inc.
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 (4)
- UPC #384703550018: Batch No. AN 3550
- Lot No. 1705722.S846
- Batch No. AN 3550AC
- Lot No. 1705122.S929.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Owen Mumford USA, 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 · Owen Mumford USA, Inc.
See all →- HighUnifine Pentips Plus pen needles distributed with incorrect needle sizes
FDA (Devices) · 2021-07-21
- ModerateFDA Recalls Autoject EI Medical Devices Due to Possible Assembly Error
FDA (Devices) · 2019-11-13
- ModerateOwen Mumford Recalls Petfine Auto Injectors Due to Assembly Error
FDA (Devices) · 2019-11-13
- HighOwen Mumford Recalls Unifine Pentips Pen Needles Due to Sterility Concerns
FDA (Devices) · 2018-01-24
- SevereFDA Recalls Autopen Classic Automatic Insulin Delivery Pens Due to Dial Defect
FDA (Devices) · 2015-07-22
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12