NIPRO HYPODERMIC NEEDLERecalls & reported problems across all models
Nipro Medical Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 6 models of NIPRO HYPODERMIC NEEDLE by Nipro Medical Corporation in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Oct 24, 2019 and May 15, 2026 — classified as 17 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Break” (27 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported NIPRO HYPODERMIC NEEDLE problems
Device problems
- Break27
- Material Fragmentation8
- Detachment of Device or Device Component4
- Material Separation4
- Patient-Device Incompatibility2
- Difficult to Remove1
Patient problems
- Foreign Body In Patient27
- Rash2
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Known Impact Or Consequence To Patient1
NIPRO HYPODERMIC NEEDLE models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NIPRO HYPODERMIC NEEDLE AH+2732Needle, Hypodermic, Single Lumen12 reports
- NIPRO HYPODERMIC NEEDLE AH+2219Needle, Hypodermic, Single Lumen9 reports
- NIPRO HYPODERMIC NEEDLE AH+2516Needle, Hypodermic, Single Lumen4 reports
- NIPRO HYPODERMIC NEEDLE AH+3013Needle, Hypodermic, Single Lumen4 reports
- NIPRO HYPODERMIC NEEDLE AH+2538Needle, Hypodermic, Single Lumen3 reports
- NIPRO HYPODERMIC NEEDLE AH+2613Needle, Hypodermic, Single Lumen1 report
Recent NIPRO HYPODERMIC NEEDLE adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMay 14, 2026Break; Material Separation
DURING LOCAL INJECTION OF LIDOCAINE PRIOR TO CHEST TUBE INSERTION, BY PROVIDER, 27G NEEDLE BROKE OFF LUER TIP AND IS CURRENTLY RETAINED IN PATIENT. PROVIDER WAS AT BEDSIDE. X-RAY ORDERED. NEEDLE WAS NOT REMOVED. ATTEMPTED REMOVAL DURING PLANNED SURGICAL PROCEDURE NEEDED FOR OTHER MEDICAL CONDITION BUT UNABLE TO SAFELY RETRIEVE, RISK OF ADDITIONAL HARM OUTWEIGHED BENEFIT OF REMOVAL. IMAGING LOCATED RETAINED FRAGMENT, NO VITAL ORGANS AT RISK. PATIENTS' CURRENT CLINICAL STATUS: DISCHARGED HOME, STABLE DISCLOSURE TO PATIENT WITH INSTRUCTIONS RETURN TO HOSPITAL IF COMPLICATIONS ARISE. NO PROLONGED STAY AS A RESULT OF THE UNRETRIEVABLE DEVICE FRAGMENT.
Patient problems: Foreign Body In Patient
MAUDE report 25179452 ↗InjuryMay 14, 2026Break; Material Separation
DURING LOCAL INJECTION OF LIDOCAINE PRIOR TO CHEST TUBE INSERTION, BY PROVIDER, 27G NEEDLE BROKE OFF LUER TIP AND IS CURRENTLY RETAINED IN PATIENT. PROVIDER WAS AT BEDSIDE. X-RAY ORDERED. NEEDLE WAS NOT REMOVED. ATTEMPTED REMOVAL DURING PLANNED SURGICAL PROCEDURE NEEDED FOR OTHER MEDICAL CONDITION BUT UNABLE TO SAFELY RETRIEVE, RISK OF ADDITIONAL HARM OUTWEIGHED BENEFIT OF REMOVAL. IMAGING LOCATED RETAINED FRAGMENT, NO VITAL ORGANS AT RISK. PATIENTS' CURRENT CLINICAL STATUS: DISCHARGED HOME, STABLE DISCLOSURE TO PATIENT WITH INSTRUCTIONS RETURN TO HOSPITAL IF COMPLICATIONS ARISE. NO PROLONGED STAY AS A RESULT OF THE UNRETRIEVABLE DEVICE FRAGMENT.
Patient problems: Foreign Body In Patient
MAUDE report 25179402 ↗MalfunctionFeb 9, 2026
DURING LOCAL INJECTION OF LIDOCAINE BY PROVIDER, 27G NEEDLE BROKE OFF LUER TIP AND IS CURRENTLY RETAINED IN PT. PROVIDER IS AT BEDSIDE. XR [XRAY] CALLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24290533 ↗InjuryOct 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
FOUR PATIENTS DEVELOPED RASHES FOLLOWING GLP-1 MEDICATION INJECTIONS ADMINISTERED FOR THE TREATMENT OF OBESITY. NONE OF THE PATIENTS HAD A HISTORY OF KNOWN ALLERGIES, AND NO INJURIES, MEDICAL INTERVENTIONS, OR HOSPITALIZATIONS WERE REQUIRED AS A RESULT OF THE REACTIONS. THE FACILITY SUBSEQUENTLY SWITCHED TO A DIFFERENT LOT OF THE PRODUCT. ALL AFFECTED PATIENTS RECOVERED FULLY, AND THE USED PRODUCT WAS DISCARDED BY THE FACILITY.
Patient problems: Rash
MAUDE report 23258827 ↗InjuryOct 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
FOUR PATIENTS DEVELOPED RASHES FOLLOWING GLP-1 MEDICATION INJECTIONS ADMINISTERED FOR THE TREATMENT OF OBESITY. NONE OF THE PATIENTS HAD A HISTORY OF KNOWN ALLERGIES, AND NO INJURIES, MEDICAL INTERVENTIONS, OR HOSPITALIZATIONS WERE REQUIRED AS A RESULT OF THE REACTIONS. THE FACILITY SUBSEQUENTLY SWITCHED TO A DIFFERENT LOT OF THE PRODUCT. ALL AFFECTED PATIENTS RECOVERED FULLY, AND THE USED PRODUCT WAS DISCARDED BY THE FACILITY.
Patient problems: Rash
MAUDE report 23258273 ↗MalfunctionJul 1, 2025Break; Break
DURING IM INJECTION IN THE RIGHT THIGH FOR PRE-OP MEDICATIONS DURING A NEUTER PROCEDURE, NEEDLE APPEARED TO SLIP OUT OF THE HUB. NEEDLE IS VISIBLE UPON X-RAY. THE CANINE APPEARS TO BE RECOVERING NORMALLY WITH NO PROBLEMS. HUB WAS DISCARDED. THE FACILITY CONTACTED A SURGICAL SPECIALIST WHEN THE INCIDENT OCCURRED AND THEY WERE ADVISED TO LEAVE THE NEEDLE IN PLACE. IT WAS EXPLAINED THAT ATTEMPTING TO FIND THE SMALL NEEDLE, IT COULD CAUSE MORE DAMAGE TO THE MUSCLE GROUP, RATHER THAN ALLOWING IT TO REMAIN AS IT MIGHT EVENTUALLY WORK ITS WAY OUT ON ITS OWN. FACILITY WAS INSTRUCTED TO HAVE AN X-RAY OF THE SITE AT LEAST ONE OR TWICE A YEAR, TO MONITOR THE POSITION OF THE NEEDLE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 22378378 ↗InjuryJul 1, 2025Break; Break
DURING IM INJECTION IN THE RIGHT THIGH FOR PRE-OP MEDICATIONS DURING A NEUTER PROCEDURE, NEEDLE APPEARED TO SLIP OUT OF THE HUB. NEEDLE IS VISIBLE UPON X-RAY. THE CANINE APPEARS TO BE RECOVERING NORMALLY WITH NO PROBLEMS. HUB WAS DISCARDED. THE FACILITY CONTACTED A SURGICAL SPECIALIST WHEN THE INCIDENT OCCURRED AND THEY WERE ADVISED TO LEAVE THE NEEDLE IN PLACE. IT WAS EXPLAINED THAT ATTEMPTING TO FIND THE SMALL NEEDLE, IT COULD CAUSE MORE DAMAGE TO THE MUSCLE GROUP, RATHER THAN ALLOWING IT TO REMAIN AS IT MIGHT EVENTUALLY WORK ITS WAY OUT ON ITS OWN. FACILITY WAS INSTRUCTED TO HAVE AN X-RAY OF THE SITE AT LEAST ONE OR TWICE A YEAR, TO MONITOR THE POSITION OF THE NEEDLE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 22378171 ↗MalfunctionFeb 7, 2025Break; Break
DURING PREPARATION FOR A PACEMAKER INSERTION, THE NEEDLE BROKE AT THE HUB INSIDE THE SUBCUTANEOUS TISSUE ON THE LEFT UPPER CHEST AREA. FLUOROSCOPY HAD TO BE USED TO LOCATE THE NEEDLE, SURGEON WAS ABLE TO INCORPORATE AN INCISION INTO THE PACEMAKER POCKET INCISION, AND REMOVED THE BROKEN PIECE WITH FORCEPS. THE PROCEDURE WAS THEN COMPLETED WITHOUT ANY OTHER IMPACT TO THE PATIENT OR COMPLICATIONS.
Patient problems: Foreign Body In Patient
MAUDE report 21339541 ↗InjuryFeb 7, 2025Break; Break
DURING PREPARATION FOR A PACEMAKER INSERTION, THE NEEDLE BROKE AT THE HUB INSIDE THE SUBCUTANEOUS TISSUE ON THE LEFT UPPER CHEST AREA. FLUOROSCOPY HAD TO BE USED TO LOCATE THE NEEDLE, SURGEON WAS ABLE TO INCORPORATE AN INCISION INTO THE PACEMAKER POCKET INCISION, AND REMOVED THE BROKEN PIECE WITH FORCEPS. THE PROCEDURE WAS THEN COMPLETED WITHOUT ANY OTHER IMPACT TO THE PATIENT OR COMPLICATIONS.
Patient problems: Foreign Body In Patient
MAUDE report 21339178 ↗MalfunctionJul 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE REPORTER NOTED THAT THEY WERE USING ONE OF OUR 27X1 ¼ HYPODERMIC NEEDLES TO NUMB A PATIENT IN THE SUBQ TISSUE IN THE GLUTE WHILE NUMBING THE PATIENT THE NEEDLES BROKE OFF THE HUB AND INTO THE PATIENT'S TISSUE. THE PATIENT HAD TO GET EXTENSIVE TREATMENT DONE TO GET THIS REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 19867777 ↗MalfunctionJun 14, 2024Break; Break
DURING A RIGHT AND LEFT SACROILIAC INJECTION, THE 27G NEEDLE SNAPPED OFF THE HUB, WHICH RESULTED IN A HOSPITAL TRANSFER TO REMOVE THE EMBEDDED NEEDLE. UNKNOWN CURRENT PATIENT CONDITION. NO ADDITIONAL INFORMATINO PROVIDED. NO SAMPLES AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 19542644 ↗InjuryJun 14, 2024Break; Break
DURING A RIGHT AND LEFT SACROILIAC INJECTION, THE 27G NEEDLE SNAPPED OFF THE HUB, WHICH RESULTED IN A HOSPITAL TRANSFER TO REMOVE THE EMBEDDED NEEDLE. UNKNOWN CURRENT PATIENT CONDITION. NO ADDITIONAL INFORMATINO PROVIDED. NO SAMPLES AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 19542527 ↗MalfunctionJun 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
WHEN THE NURSE BEGAN THE INJECTION, THE PEDIATRIC PATIENT MOVED. THE NEEDLE BROKE AT THE HUB AND BECAME SEPARATED FROM THE SYRINGE. NEEDLE REMAINED EMBEDDED IN THE PATIENT'S THIGH. THE PATIENT WAS THEN SENT TO THE EMERGENCY DEPARTMENT AND NEEDLE WAS REMOVED SURGICALLY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 19533895 ↗InjuryNov 28, 2022Break; Break
PATIENT NEEDED A CHEST TUBE PLACED IN LEFT CHEST. PROVIDER WAS INJECTING LOCAL ANESTHETIC AND THE NEEDLE BROKE OFF INTO THE SUBCUTANEOUS CHEST WALL TISSUE. UNABLE TO RETRIEVE THE NEEDLE. PATIENT THEN TAKEN INTO THE OPERATING ROOM. ADDITIONAL INFORMATION RECEIVED 11/08/2022: PATIENT WAS TAKEN TO THE OR (OPERATING ROOM) FROM THE ED (EMERGENCY DEPARTMENT). THE NEEDLE HAD MOVED 3 TO 4 INCHES FROM THE ORIGINAL INSERTION SITE. NEEDLE WAS OBTAINED USING IMAGING (2 PLAIN). PATIENT WAS NOT HARMED ANY FURTHER FROM THIS EVENT. PATIENT ULTIMATELY HAD THE NEEDLE REMOVED AND THE CHEST TUBE PLACED WHILE IN THE OR WHERE SHE WAS THEN TRANSFERRED TO A HIGHER LEVEL OF CARE.
Patient problems: Foreign Body In Patient
MAUDE report 15872520 ↗
Other Nipro Medical Corporation products
All Nipro Medical Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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