Covidien ONB12SHFRecalls & reported problems
Provision · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810041639189), received between Feb 25, 2022 and Feb 25, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2022Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCTECTOMY, WHEN AUTOMATIC SUTURING DEVICE WAS BEING USED FOR RECTAL RESECTION, THE BLUE SEAL PART GOT DAMAGED AND FELL OFF INTO THE ABDOMINAL CAVITY. THE SURGEON CHECKED THE SHAPE OF THE DAMAGED PART AND THE DROPPED PART, DETERMINED THAT ALL DAMAGED PART(S) WAS/WERE REMOVED USING FORCEPS, AND RE-STARTED THE OPERATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13606125 ↗
Other Laparoscope, General & Plastic Surgery, Reprocessed devices
- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 recall17 reports
- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 recall16 reports
- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 recall3 reports
- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 recall2 reports
- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED13 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
- 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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