Kroger AN 3550KRORecalls & reported problems
Kroger CO., The · Kroger Pentips, 5mm x 31G, 100 ct · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00041260007224), received between Mar 18, 2025 and Mar 18, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).
3 other recalls cover devices cleared under the same FDA submission (K152339); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem2
Patient problems
- Foreign Body In Patient2
- Needle Stick/Puncture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
CUSTOMER STATES THAT NEEDLE BROKE OFF IN THE SIDE OF HER ABDOMEN ON (B)(6). SHE STATES SHE DID HER INJECTION AND WHEN SHE PULLED THE NEEDLE OUT OF HER SKIN THERE WAS NO NEEDLE ON THE HUB. CUSTOMER DID SAVE THE HUB. CUSTOMER WENT TO THE DOCTOR AND THEN WAS SENT TO THE ER TO GET AN X-RAY. SHE STATED THAT THEY DIDN'T SEE THE NEEDLE, BUT THAT IT COULD BE IN HER SKIN AND JUST NOT VISIBLE GIVEN THE SMALL SIZE OF THE NEEDLE AND THAT THE INJECTION WAS NEAR HER PELVIS AND THE BONE WOULD SHOW UP AS THE SAME COLOR AS THE NEEDLE. CUSTOMER STATES THAT SHE IS MARKING A CIRCLE AROUND WHERE THE INJECTION WAS GIVEN TO WATCH FOR ANY TYPE OF SWELLING AND INFECTION, BUT IT SEEMS FINE FOR NOW. SHE IS GOING BACK TO THE DOCTOR IN MARCH AND IT WILL BE CHECKED AGAIN TO MAKE SURE EVERYTHING IS OK. CUSTOMER JUST WANTED TO LET US KNOW WHAT HAPPENED IN CASE ANYONE ELSE HAD THIS ISSUE AND REQUESTS A NEW BOX OF A DIFFERENT LOT NUMBER BECAUSE SHE IS WORRIED SOMETHING MAY BE WRONG WITH THE LOT NUMBER SHE HAS.
Patient problems: Foreign Body In Patient; Needle Stick/Puncture
MAUDE report 21633686 ↗InjuryMar 18, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
CUSTOMER STATES THAT NEEDLE BROKE OFF IN THE SIDE OF HER ABDOMEN ON (B)(6). SHE STATES SHE DID HER INJECTION AND WHEN SHE PULLED THE NEEDLE OUT OF HER SKIN THERE WAS NO NEEDLE ON THE HUB. CUSTOMER DID SAVE THE HUB. CUSTOMER WENT TO THE DOCTOR AND THEN WAS SENT TO THE ER TO GET AN X-RAY. SHE STATED THAT THEY DIDN'T SEE THE NEEDLE, BUT THAT IT COULD BE IN HER SKIN AND JUST NOT VISIBLE GIVEN THE SMALL SIZE OF THE NEEDLE AND THAT THE INJECTION WAS NEAR HER PELVIS AND THE BONE WOULD SHOW UP AS THE SAME COLOR AS THE NEEDLE. CUSTOMER STATES THAT SHE IS MARKING A CIRCLE AROUND WHERE THE INJECTION WAS GIVEN TO WATCH FOR ANY TYPE OF SWELLING AND INFECTION, BUT IT SEEMS FINE FOR NOW. SHE IS GOING BACK TO THE DOCTOR IN MARCH AND IT WILL BE CHECKED AGAIN TO MAKE SURE EVERYTHING IS OK. CUSTOMER JUST WANTED TO LET US KNOW WHAT HAPPENED IN CASE ANYONE ELSE HAD THIS ISSUE AND REQUESTS A NEW BOX OF A DIFFERENT LOT NUMBER BECAUSE SHE IS WORRIED SOMETHING MAY BE WRONG WITH THE LOT NUMBER SHE HAS.
Patient problems: Foreign Body In Patient; Needle Stick/Puncture
MAUDE report 21633124 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152339. One submission often covers many models, so check the product and lot details in each record.
- Z-2078-2021 · May 26, 2021 · Open, ClassifiedUnifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
- Z-0382-2018 · Nov 6, 2017 · TerminatedUnifine 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 d
- Z-0381-2018 · Nov 6, 2017 · TerminatedUnifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of d
Other Needle, Hypodermic, Single Lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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