Prime Series 1105 (REF 1105-000-000X)Recalls & reported problems
Stryker Corporation · Class 2
All models of Prime Series (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Stryker Prime Series 1105 is a wheeled stretcher, a mobile bed used to move patients. The 33 reports mostly describe mechanical problems: parts jamming, brakes and steering mechanisms being hard to engage, the mattress sliding off the litter, the device tipping over, and fluid leaking onto the floor. One report mentions a death and none mention injuries. One recall, started in May 2021 and still open, concerns units distributed to residential customers who may not understand the labeling instructions for use in a healthcare facility.
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
- 33
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07613327278194), received between Apr 23, 2018 and Apr 28, 2025 — classified as 1 death, 32 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (15 reports).
1 FDA recall record name this device's identifier, 1 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- May 12, 2021Class IIOpen, 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-2207-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Mechanical Jam15
- Fluid/Blood Leak5
- Device Slipped4
- Mechanical Problem3
- Positioning Failure2
- Device Fell1
- Device Tipped Over1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Patient Involvement8
- Fall1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2025Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED BRAKES DIFFICULT TO ENGAGE/DISENGAGE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21920106 ↗MalfunctionJan 24, 2025Device Slipped; Device Slipped
THIS REPORT SUMMARIZES 4 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED THE MATTRESS SLIDING OFF THE LITTER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21232870 ↗MalfunctionOct 29, 2024Device Tipped Over; Device Tipped Over
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DEVICE TIPPED OVER. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20560565 ↗MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FLUID LEAKS ONTO FLOOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20535924 ↗MalfunctionJul 29, 2024Device Slipped; Device Slipped
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED MATTRESS SLIDES OFF LITTER. THERE WERE 2 EVENTS WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19850102 ↗MalfunctionApr 23, 2024Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED STEER MECHANISM IS DIFFICULT TO ENGAGE/DISENGAGE AND BRAKES DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19163283 ↗MalfunctionApr 22, 2024Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FLUID LEAKS ONTO FLOOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19154712 ↗MalfunctionJan 24, 2024Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FLUID LEAKS ONTO FLOOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18574330 ↗MalfunctionOct 24, 2023Device Slipped; Device Slipped
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED MATTRESS SLIDES OFF LITTER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17998812 ↗MalfunctionOct 23, 2023Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED BRAKES CANNOT BE ENGAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17990330 ↗MalfunctionAug 24, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS FOUND DURING EVALUATION BY STRYKER TECHNICAL SERVICE THAT THE UNIT WAS LEAKING FLUID ONTO THE FLOOR. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17614068 ↗MalfunctionApr 26, 2023Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FLUID LEAKING ONTO THE FLOOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16817116 ↗MalfunctionApr 25, 2023Positioning Failure; Positioning Failure
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FALSE LATCH OF SIDERAIL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16811090 ↗MalfunctionJan 27, 2023Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED BRAKES DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16253171 ↗MalfunctionOct 24, 2022Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED BRAKES CAN'T ENGAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15657735 ↗MalfunctionJul 26, 2022Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED STEER DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15107391 ↗MalfunctionJul 26, 2022Sharp Edges; Sharp Edges
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15105146 ↗MalfunctionApr 26, 2022Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED BRAKES DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14209501 ↗DeathJan 28, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A PATIENT HAD ALLEGEDLY GOT THERE HEAD BETWEEN THE SIDE-RAILS AND HAS SINCE DIED. THE CUSTOMER HAS NOT STATED IF THE TRAPPING OF THE HEAD WAS DUE TO A MALFUNCTION OF THE SIDE-RAIL AND HAS PUT THE STRETCHER BACK INTO USE. THE CUSTOMER IS ALSO UNABLE TO CONFIRM THE SERIAL NUMBER OF THE STRETCHER.
Patient problems: Insufficient Information
MAUDE report 13386505 ↗MalfunctionOct 26, 2021Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED BRAKES DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12696902 ↗MalfunctionJul 27, 2021Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED BRAKES CANNOT BE ENGAGED OR BRAKES ARE DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12234085 ↗MalfunctionJul 27, 2021Device Fell; Device Fell
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED A SIDERAIL UNEXPECTED DROP/COLLAPSE. THERE WAS PATIENT INVOLVEMENT WHERE THE PATIENT FELL; NO ADVERSE CONSEQUENCES WERE REPORTED AS A RESULT OF THE FALL.
Patient problems: Fall; No Clinical Signs, Symptoms or Conditions
MAUDE report 12234011 ↗MalfunctionJan 27, 2021Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE BRAKES WERE DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11239645 ↗MalfunctionOct 27, 2020Mechanical Jam; Mechanical Jam
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE BRAKES WERE DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10741621 ↗MalfunctionOct 27, 2020Positioning Failure; Positioning Failure
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THERE WAS A FALSE LATCH OF THE SIDERAIL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10741616 ↗
Other STRETCHER, WHEELED devices
- Power-PRO 6506Stryker Corporation · STRETCHER, WHEELED5 deaths472 reports
- Procedural stretcher P8000HHill-Rom de México, S. de R.L. de C.V. · STRETCHER, WHEELED361 reports
- Prime Series 1115Stryker Corporation · STRETCHER, WHEELED1 death251 reports
- Prime Series 1115Stryker Corporation · STRETCHER, WHEELED1 recall199 reports
- Power-PRO 2, High Configuration 650705550001Stryker Corporation · STRETCHER, WHEELED2 recalls2 deaths99 reports
- NA 1089Stryker Corporation · STRETCHER, WHEELED175 reports
- NA 5050Stryker Corporation · STRETCHER, WHEELED1 recall99 reports
- Power-PRO 2 650700000000Stryker Corporation · STRETCHER, WHEELED2 recalls1 death42 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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