Medline Industries, Inc. DYNJRA2475Recalls & reported problems
Medline Industries, Inc. · TRAY, SPINAL PENCIL POINT 25G · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10198459081385), received between Nov 18, 2025 and Dec 15, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break2
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2025Break; Break
ACCORDING TO THE CUSTOMER, IN SEPTEMBER 2025, THE "25G NEEDLE BROKE OFF AT THE HUB" WITHIN THE "SUBCUTANEOUS TISSUE" AND WAS "UNABLE TO BE VISUALIZED OR PALPATED." THE CUSTOMER SAID A CT SCAN OF THE LUMBAR SPINE "SHOWED THE RETAINED NEEDLE FRAGMENT IN THE SUBCUTANEOUS TISSUE AT L1-2 LEVEL" WHICH WAS "RETRIEVED UNDER IR [INTERVENTIONAL RADIOLOGY] GUIDANCE."
Patient problems: Foreign Body In Patient
MAUDE report 23811737 ↗MalfunctionNov 18, 2025Break
DURING ANESTHETIZING OF HER SKIN FOR HER SPINAL PLACEMENT (SCHEDULED C-SECTION), THE 25G NEEDLE BROKE OFF AT THE HUB WITHIN HER SUBCUTANEOUS TISSUE. IT WAS UNABLE TO BE VISUALIZED OR PALPATED. SHE SUBSEQUENTLY UNDERWENT CESAREAN DELIVERY UNDER GENERAL ANESTHESIA. SHE HAD A CT SCAN OF HER LUMBAR SPINE WHICH SHOWED THE RETAINED NEEDLE FRAGMENT IN THE SUBCUTANEOUS TISSUE AT L1-2 LEVEL. ULTIMATELY, IT WAS RETRIEVED UNDER IR [INTERVENTIONAL RADIOLOGY] GUIDANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23582488 ↗
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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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