Medline Industries, Inc. DYNJRA1790Recalls & reported problems
Medline Industries, Inc. · SPINAL TRAY · Class 1
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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489880441), received between Jan 10, 2023 and Jan 10, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Recalls naming this device
- Apr 10, 2026Class IOpen, Classified
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Z-2237-2026 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 10, 2023Break; Break
ACCORDING TO THE CUSTOMER, A "SPINAL NEEDLE WAS INSERTED AT L3-L4, THE STYLET WAS REMOVED AND THEN THE OS WAS ENCOUNTERED. ATTEMPTED TO WITHDRAW THE WHITACRE AND INTRODUCER NEEDLE. AT THAT POINT, THE DISTAL 1/3 OF THE WHITACRE NEEDLE WAS NOTED TO BE MISSING." THE CUSTOMER REPORTED THAT THE RETAINED NEEDLE WAS CONFIRMED WITH AN X-RAY.
Patient problems: Foreign Body In Patient
MAUDE report 16130600 ↗
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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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