SEIRIN ACUPUNCTURE NEEDLE J-Type (J-Sakura) No.3(0.20)x60mmRecalls & reported problems
Seirin Corporation · The J-Type acupuncture needle is renowned for its role in producing gentle, painless and stress-free treatments. Made from the highest quality stainless steel, it features a lightweight, comfort grip, 2.0 x 20 mm plastic handle that is color coded for easy gauge identification. With Light Touch Insertion, the needle is easily released from its guide tube by gently pressing the needle away from its point of attachment on the tube. Each needle comes individually packaged with its own polypropylene guide tube, which is rounded on the end for patient comfort and is 100% PVC free. Box of 100 sterile, disposable needles. · Class 2
Data updated Oct 18, 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 04547248701246), received between Feb 4, 2025 and Jul 11, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
SEIRIN J-TYPE NO.3 (DIA0.20)×60MM ACUPUNCTURE NEEDLES WERE USED DURING THE ACUPUNCTURE TREATMENT. AFTER 5-10 MINUTES OF TREATMENT, WHEN THE ACUPUNCTURIST REMOVED THE NEEDLES, ONE TOP OF THE NEEDLE WAS FOUND REMAINED INSIDE THE BODY OF THE PATIENT. AT THIS MOMENT, THE TOP OF THE NEEDLE, AS WELL AS THE REMOVED NEEDLE SHAFT, HAVE NOT BEEN RETRIEVED YET.
Patient problems: Foreign Body In Patient
MAUDE report 22484536 ↗InjuryFeb 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
SEIRIN J-TYPE NO.3 (DIA0.20)×60MM ACUPUNCTURE NEEDLES WERE USED DURING THE ACUPUNCTURE TREATMENT. AFTER 5-10 MINUTES OF TREATMENT, WHEN THE ACUPUNCTURIST REMOVED THE NEEDLES, ONE TOP OF THE NEEDLE WAS FOUND TO HAVE REMAINED INSIDE THE BODY OF THE PATIENT. AT THIS MOMENT, THE TOP OF THE NEEDLE, AS WELL AS THE REMOVED NEEDLE SHAFT, HAVE NOT BEEN PROVIDED YET FOR EXAMINATION.
Patient problems: Foreign Body In Patient
MAUDE report 21306710 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page