CATALYST BARIATRIC BED ASM100112Recalls & reported problems
Kreg Medical Inc. · Hospital Bariatric Bed with Standing Frame and Drive · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850520008020), received between May 28, 2025 and May 28, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (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. 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
- Off-Label Use1
Patient problems
- Fall1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2025Off-Label Use; Off-Label Use
THE PATIENT WAS RESTLESS AND WAS LEANING TOWARDS THE LEFT SIDE OF THE BED. BOTH THE HEAD AND FOOT RAILS WERE DOWN. THE NURSE HAD LEFT THE ROOM TO FIND ANOTHER STAFF MEMBER TO MOVE THE PATIENT. IN THAT TIME, THE PATIENT ROLLED OVER AND FELL ONTO THE FLOOR. THE PATIENT SUFFERED SOME BLEEDING. A CT SCAN WAS DONE POST THE FALL WHICH WAS NEGATIVE.
Patient problems: Fall
MAUDE report 22101093 ↗
Other Bed, Ac-Powered Adjustable Hospital devices
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- Medline MDR107002EMedline Industries, Inc. · BED, AC-POWERED ADJUSTABLE HOSPITAL1 recall1 death374 reports
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- InTouch 2141Stryker Corporation · BED, AC-POWERED ADJUSTABLE HOSPITAL2 deaths361 reports
- Citadel Plus FX811B3B4AMABBArjohuntleigh AB · BED, AC-POWERED ADJUSTABLE HOSPITAL2 deaths358 reports
- TotalCare® Bed P1900QHill-Rom, Inc. · BED, AC-POWERED ADJUSTABLE HOSPITAL317 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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