Kroger Pen Needles 700001333Recalls & reported problems
Kroger CO., The · Sterile, single-use, 6-bevel pen needles, 31 Gauge, 8mm (5/16") Length · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00011110338235), received between Feb 28, 2019 and Feb 28, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 28, 2019Use of Device Problem
GENERIC PEN NEEDLE (KROGER / PERRIGO, MADE BY YPSOMED) DOES NOT FASTEN SECURELY TO LILLY INSULIN PEN, WHEN INJECTING INSULIN INTO DAUGHTER, INSULIN AND A SLIGHT AMOUNT OF BLOOD OCCURRED. THERE WAS NO PROBLEM WITH PRIOR PROVIDED BD AND NOVO PEN NEEDLES, THEY FASTEN SECURELY. LILLY, THE PEN PROVIDER HAS NOT TESTED THE KROGER / PERRIGO / YPSOMED NEEDLES, AND WILL TELL YOU THEY¿VE ONLY TESTED WITH BD AND NOVO. YPSOMED WHEN CONTACTED, ONLY QUOTES THEY¿VE TESTED TO ISO 11608-2, WHICH MEANS NOTHING AS NEAR AS I CAN TELL.
Patient problems: Blood Loss
MAUDE report 8381726 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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