NIPRO HYPODERMIC NEEDLE AH+2538Recalls & reported problems
Nipro Medical Corporation · Class 2
All models of NIPRO HYPODERMIC NEEDLE (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00383790002080), received between Aug 24, 2020 and May 15, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Material Separation2
Patient problems
- Foreign Body In Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2026Break; Material Separation
CUSTOMER REPORTS WHILE THE DOCTOR WAS TAKING A URINE SAMPLE THROUGH CYSTOTOMY, THE NEEDLE DISCONNECTED FROM ITS HUB AND WAS LEFT IN THE ABDOMINAL CAVITY OF A CANINE. THE NEEDLE SEPARATED AFTER ASPIRATION AND REMOVAL FROM THE ABDOMINAL CAVITY. THEY HAD TO SEDATE, TAKE X-RAYS, AND PERFORM SURGERY ON THE CANINE. THE NEEDLE WAS RETRIEVED INTACT. NO COMPLICATIONS AFTER SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 25183491 ↗InjuryAug 24, 2020Break; Material Separation
DURING A HORMONE PELLETING PROCEDURE, NEEDLE BROKE OFF INTO THE TISSUE OF THE RIGHT BUTTOCK. THE NEEDLE BROKE OFF AT THE BASE NEAR THE PLASTIC TIP. CLINIC IS CONCERNED THE NEEDLE WAS DEFECTIVE AS ROUTINE SURGICAL PROCEDURE WAS FOLLOWED AND THE PROTOCOL WAS FOLLOWED WITH AN EXPERIENCED PROVIDER. THE NEEDLE IS STILL IN THE TISSUE AND THE CLINIC IS ATTEMPTING TO GET AN INTERVENTIONAL RADIOLOGIST TO ASSIST AT THE REMOVAL, AS GENERAL SURGERY WAS UNSUCCESSFUL. 08/05/2020: THE PATIENT EVENTUALLY WAS ABLE TO GET THE NEEDLE REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 10446253 ↗InjuryAug 24, 2020Break; Break
DURING A HORMONE PELLETING PROCEDURE, NEEDLE BROKE OFF INTO THE TISSUE OF THE RIGHT BUTTOCK. THE NEEDLE BROKE OFF AT THE BASE NEAR THE PLASTIC TIP. CLINIC IS CONCERNED THE NEEDLE WAS DEFECTIVE AS ROUTINE SURGICAL PROCEDURE WAS FOLLOWED AND THE PROTOCOL WAS FOLLOWED WITH AN EXPERIENCED PROVIDER. THE NEEDLE IS STILL IN THE TISSUE AND THE CLINIC IS ATTEMPTING TO GET AN INTERVENTIONAL RADIOLOGIST TO ASSIST AT THE REMOVAL, AS GENERAL SURGERY WAS UNSUCCESSFUL. 08/05/2020: THE PATIENT EVENTUALLY WAS ABLE TO GET THE NEEDLE REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 10446083 ↗
Other Needle, Hypodermic, Single Lumen devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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