Medline Industries, Inc. DYNJRA1268CRecalls & reported problems
Medline Industries, Inc. · COMBINED SPINAL AND EPIDURAL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489905830), received between Jun 27, 2023 and Sep 24, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Oct 16, 2024Class IIOpen, Classified
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Z-0509-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Defective Device1
- Fitting Problem1
- Mechanical Problem1
Patient problems
- Needle Stick/Puncture2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Fitting Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889755 ↗MalfunctionAug 29, 2025Defective Device; Defective Device
IT WAS REPORTED THAT A 5 CC GLASS SYRINGE DID NOT IDENTIFY THE EPIDURAL SPACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22927044 ↗InjuryOct 24, 2023Mechanical Problem; Mechanical Problem
ACCORDING TO THE CUSTOMER, "EPIDURAL GLASS SYRINGE POORLY FUNCTIONING WITH LOSS OF RESISTANCE TO SALINE RESULTING IN DURAL PUNCTURE DURING EPIDURAL PLACEMENT".
Patient problems: Needle Stick/Puncture
MAUDE report 17999052 ↗InjuryJun 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, ON (B)(6)2023 THE GLASS PLUNGER WAS STUCK ON THE WALL OF THE GLASS SYRINGE WHEN USING THE SPINAL AND EPIDURAL TRAY.
Patient problems: Needle Stick/Puncture
MAUDE report 17213501 ↗
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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 · each recall links to the FDA recall notice
- 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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