MEDLINE EBSI1596Recalls & reported problems
Medline Industries, Inc. · DIALYSIS DRESSING CHANGE KIT · 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
- 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 16, 2026.
Recalls naming this device
- Jan 8, 2026Open, Classified
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Z-1467-2026 · Root cause: Process control · Recall details · FDA record ↗
Other Dressing change tray devices
- MEDLINE EBSI1498Medline Industries, Inc. · Dressing change tray2 recalls0 reports
- Centurion DT8670ACenturion Medical Products Corporation · Dressing change tray2 recalls0 reports
- Centurion Medical Products Corp DT22065Medline Industries, Inc. · Dressing change tray2 recalls0 reports
- Centurion DT21275Centurion Medical Products Corporation · Dressing change tray2 recalls0 reports
- MEDLINE EBSI1382Medline Industries, Inc. · Dressing change tray2 recalls0 reports
- Centurion DM1035Centurion Medical Products Corporation · Dressing change tray2 recalls0 reports
- Centurion DT18700Centurion Medical Products Corporation · Dressing change tray2 recalls0 reports
- MEDLINE EBSI1464Medline Industries, Inc. · Dressing change tray2 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
- 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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