Nano 320122Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00383017012236), received between Mar 10, 2026 and Jul 28, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Break

  Pharmacist reported on behalf of consumer that two of the Nano pen needles broke off into the injection site during injection. He stated that the consumer used a pair of pliars to remove the needle from the site. He also stated that there were two separate occurrences. There was no mention of medical intervention.I advised the pharmacist to have the consumer contact us to discuss further.Lot #: 5336026.Catalog #: 320122.Date of Event: unknown.Samples: discarded.vcoyne (b)(6)2026.Update/Additional Information from NACC - See Attachments. (b)(4) - Follow up for case (b)(4),This case was created as a follow up to case (b)(4) which was reported by the pharmacist on behalf of the consumer.The consumer called back reporting that there were three to four pen needles that broke off in his injection site.He stated that he was able to remove the needles with the use of a tweezer, and without any medical intervention. There was no injury or discomfort. Samples were discarded, and consumer stated that he does not re-use.

  Patient problems: Foreign Body In Patient

  MAUDE report 50059776 ↗
• InjuryJul 28, 2026Break

  Pharmacist reported on behalf of consumer that two of the Nano pen needles broke off into the injection site during injection. He stated that the consumer used a pair of pliars to remove the needle from the site. He also stated that there were two separate occurrences. There was no mention of medical intervention.I advised the pharmacist to have the consumer contact us to discuss further.Lot #: 5336026.Catalog #: 320122.Date of Event: unknown.Samples: discarded.vcoyne (b)(6)2026.Update/Additional Information from NACC - See Attachments. (b)(4) - Follow up for case (b)(4).This case was created as a follow up to case (b)(4) which was reported by the pharmacist on behalf of the consumer.The consumer called back reporting that there were three to four pen needles that broke off in his injection site.He stated that he was able to remove the needles with the use of a tweezer, and without any medical intervention. There was no injury or discomfort. Samples were discarded, and consumer stated that he does not re-use.

  Patient problems: Foreign Body In Patient

  MAUDE report 50059771 ↗
• InjuryJul 27, 2026Break

  Pharmacist reported on behalf of consumer that two of the Nano pen needles broke off into the injection site during injection. He stated that the consumer used a pair of pliars to remove the needle from the site. He also stated that there were two separate occurrences. There was no mention of medical intervention.I advised the pharmacist to have the consumer contact us to discuss further.Lot #: 5336026,Catalog #: 320122,Date of Event: unknown,Samples: discarded.vcoyne (b)(6) 2026Update/Additional Information from NACC - See Attachments. (b)(4) - Follow up for case (b)(4)This case was created as a follow up to case (b)(4) which was reported by the pharmacist on behalf of the consumer.The consumer called back reporting that there were three to four pen needles that broke off in his injection site.He stated that he was able to remove the needles with the use of a tweezer, and without any medical intervention. There was no injury or discomfort. Samples were discarded, and consumer stated that he does not re-use.

  Patient problems: Foreign Body In Patient

  MAUDE report 50013248 ↗
• MalfunctionApr 8, 2026Break

  THE CONSUMER STATED, SO FAR, HE'S HAD 8 PEN NEEDLES, (PATIENT END) BREAK OFF IN HIS INJECTION SITE AFTER SHOT. STATED, THE PEN NEEDLES ARE ALSO BENDING WHEN TAKING INJECTION STATED, DOES NOT RE-USE PEN NEEDLES STATED, HE WAS ABLE TO REMOVE THE NEEDLE FROM HIS INJECTION SITE WITH A TWEEZER. LOT: 5178030 CATALOG: 320122 DATE OF EVENT: 2026-01/14 SAMPLES: YES. TMAIK 17FEBRUARY2026: AS PER ATTACHED. THE CONSUMER SAID THE LOT COULD BE 5178030 OR 5175030. HE HAS POOR VISION VCOYNE 11MARCH2026 UPDATE/ADDITIONAL INFORMATION FROM NACC - SEE ATTACHMENTS. 00027788 7 PEN NEEDLES HAVE "UNKNOWN" INCIDENT DATES. 1 PEN NEEDLE HAS AN INCIDENT DATE OF 01/14/26. IT IS THE SAME LOT# IT IS THE SAME CATALOG# IT IS THE SAME BOX.

  Patient problems: Foreign Body In Patient

  MAUDE report 24821133 ↗
• MalfunctionMar 10, 2026Break

  THE CONSUMER STATED, SO FAR, HE'S HAD 8 PEN NEEDLES, (PATIENT END) BREAK OFF IN HIS INJECTION SITE AFTER SHOT. STATED, THE PEN NEEDLES ARE ALSO BENDING WHEN TAKING INJECTION STATED, DOES NOT RE-USE PEN NEEDLES STATED, HE WAS ABLE TO REMOVE THE NEEDLE FROM HIS INJECTION SITE WITH A TWEEZER. LOT: 5178030 CATALOG: 320122 DATE OF EVENT: 2026-01/14 SAMPLES: YES. 17FEBRUARY2026: AS PER ATTACHED. THE CONSUMER SAID THE LOT COULD BE 5178030 OR 5175030. HE HAS POOR VISION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24562675 ↗