CUB FL19HRecalls & reported problems

Summary

The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 07613327169348), received between Feb 21, 2018 and Jul 28, 2026 — classified as 4 injuries, 175 malfunctions.

The most frequently reported specific device problem is “Device Fell” (32 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Feb 18, 2026Open, Classified

   Cribs sold in the USA are missing two access door warning labels.

   Z-1580-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. May 12, 2021Open, Classified

   Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

   Z-2221-2021 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 179 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Incorrect Measurement

  This record is a consolidation of records summarized as a part of the FDA Voluntary Malfunction Summary Reporting program. Events occurred between (b)(6)- (b)(6) 2026.This report summarizes 3 malfunction events(s), where it was reported the devices experienced inaccurate measurements on the scale. No adverse consequence or clinically relevant delay in treatment was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060444 ↗
• MalfunctionJul 28, 2026Device Fell

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060437 ↗
• MalfunctionJul 28, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50056359 ↗
• MalfunctionApr 23, 2026Positioning Failure

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1- MARCH 31, 2026. THIS REPORT SUMMARIZES 7 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED END/SIDERAIL CANNOT LATCH UPRIGHT, MID-POSITION, OR STUCK AT LOWEST HEIGHT OR ACCESS DOOR UNEXPECTEDLY OPENS. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966101 ↗
• MalfunctionApr 23, 2026Sharp Edges

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1- MARCH 31, 2026. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE SHARP EDGES EXPOSED (METAL). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965122 ↗
• MalfunctionApr 22, 2026Device Fell

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1- MARCH 31, 2026. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESS DOOR UNEXPECTED DROP/COLLAPSE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958637 ↗
• MalfunctionJan 26, 2026Positioning Failure

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1-DECEMBER 31, 2025. THIS REPORT SUMMARIZES 5 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED END/SIDERAIL CANNOT LATCH UPRIGHT, MID-POSITION, OR STUCK AT LOWEST HEIGHT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183704 ↗
• MalfunctionJan 26, 2026Incorrect Measurement

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1-DECEMBER 31, 2025. THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED INACCURATE INFORMATION ON SCALES. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183702 ↗
• MalfunctionJan 26, 2026Device Fell

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1-DECEMBER 31, 2025. THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED END/SIDERAIL UNEXPECTED DROP/COLLAPSE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183540 ↗
• MalfunctionDec 18, 2025Positioning Failure; Positioning Failure

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839231 ↗
• MalfunctionOct 24, 2025Positioning Failure; Device Fell; Positioning Failure; Device Fell

  THIS REPORT NOW SUMMARIZES 0 MALFUNCTION EVENT(S), INSTEAD OF 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384165 ↗
• MalfunctionOct 24, 2025Positioning Failure; Positioning Failure

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 13 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED END/SIDERAIL CANNOT LATCH UPRIGHT, MID-POSITION, OR STUCK AT LOWEST HEIGHT, FALSE LATCH OF SIDERAIL; INADEQUATE SIDERAIL SUPPORT FORCE, OR ACCESS DOOR UNEXPECTEDLY OPENS. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384143 ↗
• MalfunctionOct 24, 2025Incorrect Measurement; Incorrect Measurement

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 5 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED INACCURATE INFORMATION ON SCALES. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384142 ↗
• MalfunctionOct 24, 2025Device Fell; Device Fell

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 12 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESS DOOR UNEXPECTED DROP/COLLAPSE OR END/SIDERAIL UNEXPECTED DROP/COLLAPSE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384141 ↗
• MalfunctionJul 25, 2025Device Fell; Device Fell

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED END/SIDERAIL UNEXPECTED DROP/COLLAPSE OR ACCESS DOOR UNEXPECTED DROP/COLLAPSE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22620738 ↗
• MalfunctionJul 25, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INCORRECT MEASUREMENT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608309 ↗
• MalfunctionJul 25, 2025Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 10 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED END/SIDERAIL CANNOT LATCH UPRIGHT, MID-POSITION, OR STUCK AT LOWEST HEIGHT, ACCESS DOOR UNEXPECTEDLY OPENS OR FALSE LATCH OF SIDERAIL. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608287 ↗
• MalfunctionApr 29, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INCORRECT MEASUREMENT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925675 ↗
• MalfunctionApr 29, 2025Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 14 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED END/SIDERAIL CANNOT LATCH UPRIGHT, MID-POSITION, ACCESS DOOR UNEXPECTEDLY OPENS, ACCESS DOOR - WONT LATCH/LOCK, OR STUCK AT LOWEST HEIGHT OR FALSE LATCH OF SIDERAIL. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT WITH A FALL; NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925660 ↗
• MalfunctionApr 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FLUID LEAKS ONTO FLOOR. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925640 ↗
• MalfunctionApr 29, 2025Device Slipped; Device Slipped

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED MATTRESS SLIDES OFF LITTER. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925627 ↗
• MalfunctionApr 29, 2025Device Fell; Device Fell

  THIS REPORT NOW SUMMARIZES 9 MALFUNCTION EVENTS, INSTEAD OF 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925617 ↗
• MalfunctionApr 28, 2025Mechanical Problem; Mechanical Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED BRAKES DO NOT REMAIN ENGAGED. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919963 ↗
• MalfunctionJan 30, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INACCURATE SCALE READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277559 ↗
• MalfunctionJan 29, 2025Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 17 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED AN END/SIDERAIL THAT COULD NOT LATCH IN POSITION, ACCESS DOOR COLLAPSE, OR THE ACCESS DOOR UNEXPECTEDLY OPENING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265744 ↗