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CARILEX MEDICAL, INC. · Model S5001-0021 · UDI-DI 04719873698189

LLI
2
510(k) clearances
1,867
Adverse events (14 deaths)
19
Recalls
43
Facilities

Description

CariRaise SYS US Carilex (R type)

Recalls

DateFirmReason
2025-11-26Medline Industries, LPMedline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its spe
2025-11-26Medline Industries, LPMedline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its spe
2025-11-26Medline Industries, LPMedline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its spe
2025-11-26Medline Industries, LPMedline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its spe
2025-11-26Medline Industries, LPMedline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its spe
2025-11-26Medline Industries, LPMedline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its spe
2024-01-22Invacare CorporationInvacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components
2022-07-11WISSNER-BOSSERHOFF GMBHWhen the handset is disconnected from the power mains, and mains operation is restored, the handset is reset to the preset Resident mode. In this mode, the backrest, legrest, and h
2017-03-24Craftmatic Industries, Inc.A potential for dual-configured beds to separate or slip away from one another.
2017-03-24Craftmatic Industries, Inc.A potential for dual-configured beds to separate or slip away from one another.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.