CLASS II Device recall · Reported 24 Jan 2018 · FDA Enforcement Report

Unifine Pentips pen needles recalled by Owen Mumford USA

Owen Mumford USA is recalling Unifine Pentips pen needles, distributed nationwide in the US. The recall was initiated on 6 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUPC #384701150012: Batch No. AN 1150, Lot No.1705711.T098; Batch No. 1150REC, Lot No. 1705722.T099; Batch No. AN 1150HEB, Lot No. 1705722.T100.

Quantity recalled708 cartons (21,240 pen needles)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0382-2018
FDA event ID: 78483
Recalling firm: Owen Mumford USA, Marietta, GA
Classification: Class II
Status: Terminated
Recall initiated: 6 Nov 2017
FDA classified: 17 Jan 2018
Reported: 24 Jan 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Syringes & Needles

Timeline

6 Nov 2017	Recall initiated by company
17 Jan 2018	Classified by FDA	+72 days
24 Jan 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Alabama Arizona California Colorado Florida Georgia Hawaii Iowa Illinois Massachusetts Michigan Minnesota Missouri Mississippi North Carolina New Hampshire New Jersey New York Ohio Oklahoma

Questions about this recall

Why was it 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 lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 78483

This product is part of a recall event; the main page for the event is Unifine Pentips pen needles recalled by Owen Mumford USA.

Reported	Class	Recall	Company	Reason	Where
24 Jan 2018	CLASS II	Unifine Pentips pen needles recalled by Owen Mumford USA	Owen Mumford USA	Sterility	Nationwide

More recalls from Owen Mumford USA

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Reported	Class	Recall	Company	Reason	Where
21 Jul 2021Device	CLASS II	Unifine Pentips Plus, hypodermic needle recalled by Owen Mumford USA	Owen Mumford USA	Other	Nationwide
13 Nov 2019Device	CLASS II	Petfine Auto Injector recalled by Owen Mumford USA	Owen Mumford USA	Other	13 states
13 Nov 2019Device	CLASS II	Autoject EI recalled by Owen Mumford USA	Owen Mumford USA	Other	13 states
24 Jan 2018Device	CLASS II	Unifine Pentips pen needles recalled by Owen Mumford USA	Owen Mumford USA	Sterility	Nationwide
22 Jul 2015Device	CLASS II	Autopen Classic Automatic insulin delivery pen x 2-, AN3800 recalled	Owen Mumford USA	Device Malfunction	Nationwide

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