Medline Industries, Inc. DYNJS0840Recalls & reported problems
Medline Industries, Inc. · SHOULDER SPLIT I-LF · Class 1
Data updated Oct 16, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196934706), received between Jul 8, 2025 and Sep 17, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Recalls naming this device
- Nov 17, 2022Class IIOpen, Classified
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Z-1096-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
- No Apparent Adverse Event1
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.
MalfunctionSep 17, 2026No Apparent Adverse Event
It was reported that no defect was described in the Complaint text.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802894 ↗InjuryJul 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE CUSTOMER, THE "BLADE CAME OFF OF HANDLE AND STUCK INTO PATIENT'S BONE" WHILE MAKING A "SURGICAL INCISION" ON (B)(6) 2025.
Patient problems: Foreign Body In Patient
MAUDE report 22437864 ↗
Other Orthopedic tray devices
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- Medline Industries, Inc. DYNJ900718CMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. CDS780119VMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ21826RMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ906893DMedline Industries, Inc. · Orthopedic tray4 recalls2 reports
- Medline Industries, Inc. DYNJ909505AMedline Industries, Inc. · Orthopedic tray4 recalls1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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