Medline Industries, Inc. DYNJS0126Recalls & reported problems
Medline Industries, Inc. · SURE SET-SINGLE BASIN-LF · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196964468), received between Mar 26, 2024 and Sep 24, 2026 — classified as 2 malfunctions.
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 18, 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-1079-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Extra Components1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Extra Components
It was reported that there were 11 Raytec in the bundle instead of 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881997 ↗MalfunctionMar 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BULB OF A BULB IRRIGATION SYRINGE COMPONENT DETACHED FROM THE BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18984461 ↗
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- Medline Industries, Inc. DYNJ42382BMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Centurion ART690Centurion Medical Products Corporation · General Surgery Tray4 recalls0 reports
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- Medline Industries, Inc. DYNDL1350AMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ69692Medline Industries, Inc. · General surgery tray4 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 · 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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