Medline Industries, Inc. DYKS1468Recalls & reported problems
Medline Industries, Inc. · PRE OP KIT · 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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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
- Nov 26, 2025Class IIOpen, Classified
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Z-1057-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other Skin prep tray devices
- Medline Industries, Inc. DYKS1325AMedline Industries, Inc. · Skin prep tray2 recalls0 reports
- Medline Industries, Inc. DYKS1584AMedline Industries, Inc. · Skin prep tray2 recalls0 reports
- Medline Industries, Inc. DYKS1128CMedline Industries, Inc. · Skin prep tray2 recalls0 reports
- MEDLINE INDUSTRIES, INC. DYKS1216IMedline Industries, Inc. · Skin prep tray2 recalls0 reports
- Medline Industries, Inc. DYNDL1643AMedline Industries, Inc. · Skin prep tray1 recall1 report
- MEDLINE INDUSTRIES, INC. DYKS1124CMedline Industries, Inc. · Skin prep tray1 recall0 reports
- Medline Industries, Inc. DYKS2018Medline Industries, Inc. · Skin prep tray1 recall0 reports
- Medline Industries, Inc. DYKS1043FMedline Industries, Inc. · Skin prep tray1 recall0 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
- 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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