Busse Hospital Disposables 1443Recalls & reported problems
Robert Busse & CO., Inc. · Sterile Dressing Change Tray · 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
- 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 30, 2023Class IOpen, Classified
Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
Z-0593-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other Wound Dressing Kit devices
- Medline Industries, Inc. DYNDH1487AMedline Industries, Inc. · Wound dressing kit3 recalls0 reports
- Medline Industries, Inc. DM1035Medline Industries, Inc. · Wound dressing kit2 recalls0 reports
- Medline Industries, Inc. DYNDH1193Medline Industries, Inc. · Wound dressing kit2 recalls0 reports
- Medline Industries, Inc. DYKMBNDL43Medline Industries, Inc. · Wound dressing kit2 recalls0 reports
- Medline Industries, Inc. DYNDH1561Medline Industries, Inc. · Wound dressing kit2 recalls0 reports
- Medline Industries, Inc. SUT13535Medline Industries, Inc. · Wound dressing kit2 recalls0 reports
- Medline Industries, Inc. DYNJ47717AMedline Industries, Inc. · Wound dressing kit2 recalls0 reports
- Medline Industries, Inc. DYNDC2733Medline Industries, Inc. · Wound dressing kit1 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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