NIPRO SYRINGE JD+03L2238Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00383790000789), received between Jul 2, 2024 and Feb 7, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (4 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Material Disintegration; Material Disintegration

  (11/25/24): ISSUE REPORTED AS "SYRINGE IS LEAKING," BUT NO LOT NUMBER PROVIDED. THE MEDICATION BEING USED IS "PROGESTERONE IN OIL." (12/18/24): 2 TOTAL EVENTS. ISSUES REPORTED AS "HARD TO PUSH THE PLUNGER" AND "HARD TO DRAW AND INJECT MEDICATION," WITH LOT NUMBER 24G22 PROVIDED FOR ONE EVENT. THE MEDICATION BEING USED IS "PROGESTERONE IN OIL." (12/18/24): ISSUE REPORTED AS "PARTICLES/RUBBER STOPPER PIECES STICKING TO THE WALLS OF THE SYRINGE," WITH NO LOT NUMBER PROVIDED. THE MEDICATION BEING USED IS "PROGESTERONE IN OIL.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21340003 ↗
• MalfunctionFeb 7, 2025Material Disintegration; Material Disintegration

  (B)(6) 2024): ISSUE REPORTED AS "SYRINGE IS LEAKING," BUT NO LOT NUMBER PROVIDED. THE MEDICATION BEING USED IS "PROGESTERONE IN OIL." (B)(6) 2024): 2 TOTAL EVENTS. ISSUES REPORTED AS "HARD TO PUSH THE PLUNGER" AND "HARD TO DRAW AND INJECT MEDICATION," WITH LOT NUMBER 24G22 PROVIDED FOR ONE EVENT. THE MEDICATION BEING USED IS "PROGESTERONE IN OIL." (B)(6) 2024): ISSUE REPORTED AS "PARTICLES/RUBBER STOPPER PIECES STICKING TO THE WALLS OF THE SYRINGE," WITH NO LOT NUMBER PROVIDED. THE MEDICATION BEING USED IS "PROGESTERONE IN OIL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339981 ↗
• InjuryJul 2, 2024Material Disintegration; Patient-Device Incompatibility; Material Disintegration; Patient-Device Incompatibility

  PATIENT HAS BEEN USING THE 3ML 22G X 1.5'' SYRINGE TO DRAW AND INJECT PROGESTERONE IN ETHYL OLEATE 50 MG/ML. SHE CLAIMED THE PRODUCT WAS NEVER IN DIRECT SUNLIGHT AND WAS OUTSIDE OF HER HOUSE FOR ABOUT 5 MINUTES BEFORE BRINGING IN THE PACKAGE. SHE IS REPORTING LONG TERM SIDE EFFECTS FROM USING THE SYRINGE, INCLUDING INJECTION SITE PAIN WHOLE BODY CHILLS, ACHES AND FEVER. ACCORDING TO ADDITIONAL INFORMATION RECEIVED FROM THE END-USER, THE PATIENT'S HUSBAND WAS TRAINED ON HOW TO ADMINISTER INJECTIONS. PATIENT BEGAN USING PROGESTERONE IN ETHYL OLEATE ON (B)(6) 2024. PATIENT HAD AN UNOPENED BOTTLE WHEN THE SECOND CYCLE BEGAN ON (B)(6) 2024. PATIENT WAS ADVISED BY HER FERTILITY TEAM THAT THE UNUSED PRODUCT COULD BE USED DURING THE SECOND CYCLE. USED THE MEDICATION FOR THE 4 DAYS THAT THE "FAULTY" SYRINGES WERE USED, THEN DISCARDED THE REMAINING MEDICATION FEARING IT WAS CONTAMINATED. MEDICATION IS ADMINISTERED IM(INTRAMUSCULAR) IN THE GLUTEAL MUSCLE. PATIENT BEGAN EXPERIENCING SYMPTOMS OF SORENESS AT THE INJECTION SITE, ALONG WITH MUSCLE KNOT, AROUND 8 HOURS AFTER THE INJECTION WAS GIVEN. BY THE EVENING OF (B)(6) 2024 PATIENT STARTED TO FEEL AN INCREASE IN SORENESS AND DEVELOPED LOW GRAD

  Patient problems: Fever; Pain

  MAUDE report 19660221 ↗
• MalfunctionJul 2, 2024Material Disintegration; Patient-Device Incompatibility; Material Disintegration; Patient-Device Incompatibility

  PATIENT HAS BEEN USING THE 3ML 22G X 1.5'' SYRINGE TO DRAW AND INJECT PROGESTERONE IN ETHYL OLEATE 50 MG/ML. SHE CLAIMED THE PRODUCT WAS NEVER IN DIRECT SUNLIGHT AND WAS OUTSIDE OF HER HOUSE FOR ABOUT 5 MINUTES BEFORE BRINGING IN THE PACKAGE. SHE IS REPORTING LONG TERM SIDE EFFECTS FROM USING THE SYRINGE, INCLUDING INJECTION SITE PAIN WHOLE BODY CHILLS, ACHES AND FEVER. ACCORDING TO ADDITIONAL INFORMATION RECEIVED FROM THE END-USER, THE PATIENT'S HUSBAND WAS TRAINED ON HOW TO ADMINISTER INJECTIONS. PATIENT BEGAN USING PROGESTERONE IN ETHYL OLEATE ON 03/28/2024-04/11/2024. PATIENT HAD AN UNOPENED BOTTLE WHEN THE SECOND CYCLE BEGAN ON 05/31/2024. PATIENT WAS ADVISED BY HER FERTILITY TEAM THAT THE UNUSED PRODUCT COULD BE USED DURING THE SECOND CYCLE. USED THE MEDICATION FOR THE 4 DAYS THAT THE "FAULTY" SYRINGES WERE USED, THEN DISCARDED THE REMAINING MEDICATION FEARING IT WAS CONTAMINATED. MEDICATION IS ADMINISTERED IM(INTRAMUSCULAR) IN THE GLUTEAL MUSCLE. PATIENT BEGAN EXPERIENCING SYMPTOMS OF SORENESS AT THE INJECTION SITE, ALONG WITH MUSCLE KNOT, AROUND 8 HOURS AFTER THE INJECTION WAS GIVEN. BY THE EVENING OF 06/01/2024 PATIENT STARTED TO FEEL AN INCREASE IN SORENESS AND DEVELOPED

  Patient problems: Fever; Pain

  MAUDE report 19658551 ↗