Medline Industries, Inc. PAIN2152Recalls & reported problems
Medline Industries, Inc. · ESI TRAY · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10198459065248), received between Jun 16, 2025 and Nov 5, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (1 report).
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
- Defective Device1
- Difficult to Remove1
- Insufficient Device Problem Information1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 5, 2025Difficult to Remove; Defective Device; Difficult to Remove; Defective Device
ACCORDING TO THE FACILITY, "THE STYLET WOULD NOT REMOVE FROM THE NEEDLE. THE NEEDLE WAS REMOVED AND THE DOCTOR HAD TO STICK THE PATIENT AGAIN WITH ANOTHER NEEDLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23482000 ↗MalfunctionAug 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE STYLET WAS UNABLE TO BE REMOVED ON AN 18G SPINAL NEEDLE. THE PROVIDER HAD TO RE-STICK THE PATIENT USING ANOTHER NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22832769 ↗MalfunctionJun 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
"18 G SPINAL NEEDLE IS DEFECTIVE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22210822 ↗
Other Spinal epidural anesthesia kit devices
- Medline Industries, Inc. DYNJRA9040Medline Industries, Inc. · Spinal epidural anesthesia kit2 recalls2 reports
- Medline Industries, Inc. DYNJ34418MMedline Industries, Inc. · Spinal epidural anesthesia kit2 recalls1 report
- Design Options® 530184B. Braun Medical Inc. · Spinal epidural anesthesia kit2 recalls1 report
- Design Options® 530159B. Braun Medical Inc. · Spinal epidural anesthesia kit2 recalls0 reports
- Medline Industries, Inc. DYNJ34418LMedline Industries, Inc. · Spinal epidural anesthesia kit2 recalls0 reports
- Medline Industries, Inc. DYNJRA1849Medline Industries, Inc. · Spinal epidural anesthesia kit2 recalls0 reports
- Medline Industries, Inc. DYNJRA1739BMedline Industries, Inc. · Spinal epidural anesthesia kit2 recalls0 reports
- Medline Industries, Inc. DYNJRA1739AMedline Industries, Inc. · Spinal epidural anesthesia kit2 recalls0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page