The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2078-2021·Announced 2021-07-21

Unifine Pentips Plus pen needles distributed with incorrect needle sizes

Owen Mumford USA is recalling Unifine Pentips Plus pen needles because two cases of 4mm needles were mistakenly packaged as 8mm needles, which could result in patients receiving incorrect needle sizes for their insulin pens.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall involving incorrect needle sizes mixed into product packaging. No illnesses or injuries have been reported in the source. This is a risk-of-harm medical device mixup where patients could receive wrong-sized needles affecting proper insulin delivery.

Plain-English summary

Owen Mumford USA, Inc. is recalling Unifine Pentips Plus hypodermic pen needles due to a packaging error. Two cases of 4mm pen needles were inadvertently mixed into cartons labeled as 8mm pen needles.

Patients using the wrong needle size may experience improper medication delivery, difficulty with injection technique, or discomfort. The recalled product comprises 2,593 cartons of 100 needles per carton.

The recalled product was distributed nationwide to multiple U.S. states. Affected lot numbers are 20V4001.Z3999, 20V4001.Z4019, and 20V4001.Z411.

Patients and healthcare providers who have purchased affected cartons should stop using the product immediately and contact Owen Mumford USA with their lot numbers to request a replacement.

The recalled product

Product
Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
Manufacturer
Owen Mumford USA, Inc.
Category
Medical Device — Injection / Pen Needles
Hazard

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 (2)

  • Lot numbers: 20V4001.Z3999
  • Lot 20V4001.Z4019 and 20V4001.Z411

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

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