Coons G04443Recalls & reported problems
Cook Incorporated · Dilator Coons Taper · Class 2
Data updated Oct 13, 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002044432), received between Jul 28, 2022 and Jul 28, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 1, 2024Open, Classified
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1532-2024 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Device Damaged Prior to Receipt by User1
- Unsealed Device Packaging1
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.
MalfunctionJul 28, 2022Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Unsealed Device Packaging; Device Damaged Prior to Receipt by User
IT WAS REPORTED TO COOK THAT A COONS DILATOR ARRIVED TO THE CUSTOMER IN AN UNSEALED PACKAGE. THE DEVICE WAS UNUSED AND MADE NO PATIENT CONTACT. NO ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15125566 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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