FDA Medical Device Recalls (openFDA)
Owen Mumford USA, Inc.: Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
- Recall number
- Z-2078-2021
- Recalling firm
- Owen Mumford USA, Inc.
- Product
- Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
- Status
- Open, Classified
- Initiated
- 2021-05-26
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Lot numbers: 20V4001.Z3999, Lot 20V4001.Z4019 and 20V4001.Z411
- 510(k) numbers
- ["K152339"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 1000219614
- Firm city
- Marietta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28