Gyrus ACMI ST-CR2Recalls & reported problems
Gyrus ACMI, LLC · CYSTOSCOPY RESECTION Storage-Sterilization Tray Double Layer · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821925007864), received between Nov 2, 2021 and May 14, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Residue After Decontamination” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Residue After Decontamination2
- Device Damaged Prior to Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2025Residue After Decontamination; Residue After Decontamination
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22022230 ↗MalfunctionMay 14, 2025Residue After Decontamination; Residue After Decontamination
IT WAS REPORTED THE SUBJECT DEVICE HAD BLACK RESIDUE ON THE SURFACE OF THE CONTAINERS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22022149 ↗MalfunctionNov 2, 2021Device Damaged Prior to Use; Device Damaged Prior to Use
AS REPORTED , DURING DEVICE RECEIPT INSPECTION, THE LID TO THE TRAY WAS OBSERVED TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO USER INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12735338 ↗
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- n.a. 39501BECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501XKKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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