Cook G00993Recalls & reported problems
Cook Incorporated · Dilator · 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 00827002009936), received between Apr 28, 2023 and Apr 28, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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-1530-2024 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
Patient problems
- Insufficient Information1
- 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.
MalfunctionApr 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
ADDITIONAL INFORMATION WAS PROVIDED ON 01MAY2023 INDICATING THAT THE FOREIGN MATTER WAS DISCOVERED IN THE STOCK ROOM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16838661 ↗
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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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