Z-2078-2021Class II

Unifine Pentips Plus, hypodermic needle -

Name: Z-2078-2021 Unifine Pentips Plus, hypodermic needle -
Creator: Owen Mumford USA, Inc.
Published: 2021-05-26
License: https://open.fda.gov/license/

Owen Mumford USA, Inc. / initiated 2021-05-26 / Open, Classified / root cause: packaging

FDA source

Owen Mumford USA, Inc. began a recall of Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover on 2021-05-26. FDA classified it as Class II and gives the reason as "Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2078-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-26
Posted: 2021-07-15
Recalling firm: Owen Mumford USA, Inc.
Product: Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: The firm sent an e-mail on 05/06/2019 to all the distributors. The distributors were directed to quarantine all affected product and contact the company for return. Distributors were also directed to cease distribution and contact their customers (Pharmacies) with recall notification with instructions to contact Owen Mumford with product return, if any on hand..
Quantity in commerce: 2,593 cartons of 100 ea.
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, TX, UT, VA, VT, WA, and WV.
Product codes and lots: Lot numbers: 20V4001.Z3999, Lot 20V4001.Z4019 and 20V4001.Z411

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2078-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2078-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-15

Product code FMI

K152339Class IIUnifine Pentips/ Unifine Pentips PlusOwen Mumford, Ltd. / cleared 2016-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)