NA 15966-03Recalls & reported problems
Steris Mexico, S. de R.L. de C.V. · The Loading Car with 2 Shelves (8STU, 51-Inch, 1290 mm) is used with the AMSCO 600 Steam Sterilizer. · Class 2
Data updated Oct 13, 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 07350109400069), received between Jul 20, 2023 and Jul 20, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sharp Edges” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Sharp Edges1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2023Sharp Edges; Sharp Edges
THE USER FACILITY REPORTED THAT AN EMPLOYEE BUMPED THEIR FINGERS INTO THE BOTTOM SIDE OF THE METAL FRAME OF THEIR LOADING CAR AFTER PLACING A TRAY ON THE SHELF. AS A RESULT THE EMPLOYEE OBTAINED A CUT ON TWO OF THEIR FINGERS; THE EMPLOYEE RECEIVED STITCHES AND A BANDAGE. THE EMPLOYEE RETURNED TO WORK THE SAME DAY.
Patient problems: Laceration(s)
MAUDE report 17367493 ↗
Other Sterilizer, steam devices
- NA P2131-2Fort Defiance Industries, LLC · Sterilizer, Steam1 recall0 reports
- STATCLAVE G4 Chamber Autoclave G4-621103Scican Ltd · Sterilizer, Steam1 recall0 reports
- STATCLAVE G4 Chamber Autoclave G4-622303Scican Ltd · Sterilizer, Steam1 recall0 reports
- NA AX083020003Steris Mexico, S. de R.L. de C.V. · Sterilizer, steam23 reports
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam11 reports
- Atlas AX0660230830000013Steris Mexico, S. de R.L. de C.V. · Sterilizer, steam9 reports
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam9 reports
- AMSCO AMSCO 600 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam8 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- 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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