ALLEN 102001 (REF O-YFES)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00615521020149), received between Oct 11, 2022 and Aug 27, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Fell” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Device Dislodged or Dislocated

  Baxter received a report that ALLEN YELLOFIN ELITE had stirrup does not stay tight. This occurred before use. There was no patient/user injury, medical intervention, symptom, or adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50465739 ↗
• MalfunctionAug 25, 2026Device Fell

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438959 ↗
• MalfunctionAug 6, 2026Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158606 ↗
• MalfunctionJun 10, 2025Device Fell; Device Fell

  BAXTER RECEIVED A REPORT STATING THAT ALLEN YELLOFIN ELITE SCREW HOLDING THE HYDRAULICS BROKE OFF AND THE HOUSING FALL APART. THE BED WAS LOCATED AT THE ACCOUNT AND OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176212 ↗
• MalfunctionMar 24, 2025Device Fell; Device Fell

  BAXTER RECEIVED AN INCIDENT NOTIFICATION FROM BFARM STATING THAT YELLOWFIN LEG HOLDER CRASHED DOWN WITH THE PATIENT'S LEG DURING A GYNECOLOGICAL OPERATION AND FELL OFF THE STANDARD RAIL. THERE WAS NO PATIENT/USER INJURY, NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21681471 ↗
• InjuryDec 6, 2022Positioning Problem; Positioning Problem

  CUSTOMER REPORTED THAT THE YELLOFINS MALFUNCTIONED RESULTING IN PATIENT MALPOSITIONING. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED RIGHT LOWER EXTREMITY PAIN AND WEAKNESS. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 15923585 ↗
• InjuryOct 11, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT NEEDED A FASCIOTOMY FOLLOWING THE USE OF THE YELLOWFINS STIRRUPS DUE TO IMPROPER POSITIONING OF THE PATIENT. THIS EVENT WAS CAPTURED UNDER HILL-ROM COMPLAINT REF # (B)(4).

  Patient problems: Pain

  MAUDE report 15579640 ↗