Busse Hospital Diposables B1352Recalls & reported problems
Robert Busse & CO., Inc. · SS 3.5MM Pellet Insertion Tray with Large Gloves · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier.
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
- Feb 22, 2022Class IITerminated
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Z-1182-2022 · Root cause: Other · Recall details · FDA record ↗
- Feb 22, 2022Class IITerminated
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Z-1181-2022 · Root cause: Other · Recall details · FDA record ↗
Other Trocar, Gastro-Urology devices
- Busse Hospital Disposables B1354Robert Busse & CO., Inc. · Trocar, Gastro-Urology2 recalls0 reports
- Busse Hosptial Disposables B1654Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital Disposables B1568Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital Disposables B1144Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital Disposables B7345Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital Disposables B1570Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital DIsposables B1351Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital Disposables B1365Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 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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