NA 15966-02Recalls & reported problems
Steris Mexico, S. de R.L. de C.V. · The Loading Car with 2 Shelves (6STU, 39-Inch, 990 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07350109400052), received between Dec 22, 2023 and Sep 26, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Fell” (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.
Reports received per month
Most reported problems
Device problems
- Device Fell1
- Sharp Edges1
Patient problems
- Bone Fracture(s)1
- Laceration(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2025Sharp Edges; Sharp Edges
THE USER FACILITY REPORTED THAT EMPLOYEES ARE OBTAINING "LACERATIONS" TO THEIR HANDS WHILE UTILIZING THEIR LOADING CAR. IT IS UNKNOWN IF THE EMPLOYEES SOUGHT OR RECEIVED MEDICAL TREATMENT.
Patient problems: Laceration(s)
MAUDE report 23155379 ↗InjuryDec 22, 2023Device Fell; Device Fell
THE USER FACILITY REPORTED THAT THE GUARD RAIL TO THEIR LOADING CAR DETACHED AND FELL ONTO AN EMPLOYEE'S FOOT RESULTING IN A BROKEN TOE. MEDICAL TREATMENT SOUGHT AND ADMINISTERED.
Patient problems: Bone Fracture(s)
MAUDE report 18380764 ↗
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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