Prime SeriesRecalls & reported problems across all models
Stryker Corporation · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Prime Series model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,548
- Deaths reported
- 2
- Injuries reported
- 47
- Recalls
- 2
We found 21 models of Prime Series by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 1,548 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2018 and May 18, 2026 — classified as 2 deaths, 47 injuries, 1,499 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (357 reports).
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Prime Series recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-2208-2021 · Root cause: Under Investigation by firm · Recall details · 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-2207-2021 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported Prime Series problems
Device problems
- Mechanical Jam357
- Electrical /Electronic Property Problem189
- Fluid/Blood Leak166
- Grounding Malfunction140
- Mechanical Problem124
- Intermittent Loss of Power114
- Unintended System Motion112
- Sharp Edges97
Patient problems
- No Clinical Signs, Symptoms or Conditions1,122
- No Patient Involvement330
- Pain32
- Insufficient Information28
- No Consequences Or Impact To Patient22
- Fall20
- Laceration(s)13
- Muscle/Tendon Damage11
Prime Series models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Prime Series 1115STRETCHER, WHEELED1 death251 reports
- Prime Series 1115STRETCHER, WHEELED1 recall199 reports
- Prime Series 1125STRETCHER, WHEELED, POWERED240 reports
- Prime Series 1125STRETCHER, WHEELED, POWERED200 reports
- Prime Series 1105STRETCHER, WHEELED1 recall77 reports
- Prime Series 1105STRETCHER, WHEELED112 reports
- Prime Series 1105STRETCHER, WHEELED1 recall1 death33 reports
- Prime Series 1115STRETCHER, WHEELED80 reports
- Prime Series 1125STRETCHER, WHEELED, POWERED77 reports
- Prime Series 1125STRETCHER, WHEELED, POWERED71 reports
- Prime Series 1105STRETCHER, WHEELED63 reports
- Prime Series 1115STRETCHER, WHEELED60 reports
- Prime Series 1115STRETCHER, WHEELED59 reports
- Prime Series 1115STRETCHER, WHEELED8 reports
- Prime Series 1105STRETCHER, WHEELED6 reports
- Prime Series 1125Stretcher, wheeled, powered4 reports
- Prime Series 1115EHT3STRETCHER, WHEELED3 reports
- Prime Series 1115STRETCHER, WHEELED2 reports
- Prime Series 1105MHT1STRETCHER, WHEELED1 report
- Prime Series 1125Stretcher, wheeled, powered1 report
- Prime Series 1105STRETCHER, WHEELED1 report
Recent Prime Series adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT WHILE TRANSPORTING A PRODUCT, THE OFFICE WORKER'S FINGER GOT CAUGHT UNDER THE BED WHEN THEY WENT OVER A STEP RESULTING IN A FRACTURED FINGER. THE CUSTOMER REPORTED THAT, ALTHOUGH AN ADVERSE EVENT OCCURRED, THE PRODUCT WAS FUNCTIONING CORRECTLY, AND THE CUSTOMER DID NOT WISH TO HAVE THE DEVICE INSPECTED.
Patient problems: Bone Fracture(s)
MAUDE report 25209439 ↗MalfunctionMay 13, 2026Incorrect Measurement
IT WAS REPORTED THAT SCALE WAS READING INACCURATELY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THE DEVICE WAS NOT EVALUATED, AS A PROBABLE CAUSE FOR THE ISSUE WAS IDENTIFIED DURING COMMUNICATION BETWEEN THE CUSTOMER AND STRYKER AND NO FURTHER ASSISTANCE WAS REQUESTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164419 ↗MalfunctionApr 23, 2026Device Slipped
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 MATTRESS SLIDES OFF LITTER; UNSTABLE MATTRESS SUPPORT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966341 ↗MalfunctionApr 23, 2026Unintended System Motion
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 21 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED UNINTENDED DIRECTION OF THE ZOOM; UNINTENDED MOTION OR UNINTENDED EXCESSIVE SPEED OF THE ZOOM. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966104 ↗MalfunctionApr 23, 2026Unintended System Motion
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 UNINTENDED DIRECTION OF THE ZOOM; UNINTENDED MOTION. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966100 ↗MalfunctionApr 23, 2026Mechanical Jam
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 2 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED STEER MECHANISM IS 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 24966098 ↗MalfunctionApr 23, 2026Unintended System Motion
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 2 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED UNINTENDED DIRECTION OF THE ZOOM; UNINTENDED MOTION. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965282 ↗MalfunctionApr 23, 2026Unintended System Motion
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 26 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED UNINTENDED DIRECTION OF THE ZOOM; UNINTENDED MOTION OR UNINTENDED EXCESSIVE SPEED OF THE ZOOM. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965278 ↗MalfunctionApr 23, 2026Unintended System Motion
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 1 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED UNINTENDED DIRECTION OF THE ZOOM; UNINTENDED MOTION. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965276 ↗MalfunctionApr 23, 2026No Audible Alarm
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 CLINICIAN NOT ALERTED/AWARE OF POSSIBLE PATIENT FALL CONDITION. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965272 ↗MalfunctionApr 23, 2026Mechanical Jam
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 STEER MECHANISM IS 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 24965132 ↗MalfunctionApr 23, 2026Device Slipped
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 MATTRESS SLIDES OFF LITTER; UNSTABLE MATTRESS SUPPORT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965131 ↗MalfunctionApr 23, 2026Mechanical Jam
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 9 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED STEER MECHANISM IS 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 24965130 ↗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 2 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 24965128 ↗MalfunctionApr 23, 2026Unintended System Motion
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 UNINTENDED EXCESSIVE SPEED OF THE ZOOM. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965127 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
- InTouch5 models · 666 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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