CUB FL19HRecalls & reported problems
Stryker Corporation · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Stryker CUB is a pediatric hospital crib. Many of the 180 reports describe the crib falling or slipping, side rails not latching and inaccurate scale readings. The reports include 176 malfunctions, 4 injuries and no deaths. Two recalls are open: one because two access door warning labels are missing, and one because hospital-use devices were sold to home users.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 179
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 2
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.
Reports received per month
Recalls naming this device
- 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 ↗
- 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
Device problems
- Device Fell32
- Positioning Failure31
- Incorrect Measurement27
- Mechanical Problem14
- Device Slipped11
- Mechanical Jam10
- Loose or Intermittent Connection9
- Break8
Patient problems
- No Clinical Signs, Symptoms or Conditions88
- No Known Impact Or Consequence To Patient45
- No Patient Involvement29
- No Consequences Or Impact To Patient10
- Abrasion2
- Injury2
- Physical Entrapment2
- Concussion1
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 ↗
Other BED, PEDIATRIC OPEN HOSPITAL devices
- NA 4400Stryker Corporation · BED, PEDIATRIC OPEN HOSPITAL1 report
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 · each recall links to the FDA recall notice
- 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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