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NA 4701Recalls & reported problems

Stryker Corporation · Class 2

Quick summary

This Stryker obstetrical table has 129 adverse event reports on record, with no deaths and 3 injuries. The reports mostly describe foot sections that do not latch or lock, sharp metal edges, and the table moving unexpectedly or parts falling off. Most say no clinical signs were reported. There are no recalls naming this device. The last 12 months show 6 reports, compared with 12 in the 12 months before.

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
129
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 07613327278095), received between Feb 22, 2018 and Jul 28, 2026 — classified as 3 injuries, 126 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (29 reports).

4 other recalls cover devices cleared under the same FDA submission (K950889); they may or may not involve this specific model.

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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 4 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 4 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 4 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 7 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 4 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 5 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 3 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 3 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 2 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Positioning Failure29
  • Mechanical Problem24
  • Sharp Edges20
  • Device Fell16
  • Electrical /Electronic Property Problem12
  • Unintended System Motion12
  • Break5
  • Positioning Problem4

Patient problems

  • No Clinical Signs, Symptoms or Conditions91
  • No Patient Involvement23
  • No Known Impact Or Consequence To Patient7
  • No Consequences Or Impact To Patient3
  • Injury2
  • Insufficient Information2
  • Pain2

Recent adverse event reports

The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 28, 2026

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50054211 ↗
  • 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 FOOT SECTION DOES NOT LATCH/LOCK (FALSE LATCH) OR ABDUCTION ASSEMBLY FALSE LATCH. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24967204 ↗
  • 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 24966913 ↗
  • MalfunctionJan 27, 2026Device Slipped

    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 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED INADEQUATE RETENTION FORCE; SUPPORT SURFACE COULD SLIDE OFF FRAME. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24189139 ↗
  • MalfunctionJan 27, 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 4 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FOOT SECTION DOES NOT LATCH/LOCK (FALSE LATCH). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24189135 ↗
  • MalfunctionJan 27, 2026Sharp Edges

    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 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP METAL EDGES. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24189134 ↗
  • MalfunctionOct 27, 2025Sharp Edges; Sharp Edges

    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 3 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE 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 23392295 ↗
  • MalfunctionOct 27, 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 10 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FOOT SECTION DOES NOT LATCH/LOCK (FALSE LATCH). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23392147 ↗
  • MalfunctionOct 27, 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 2 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED STIRRUPS/CALF SUPPORT UNEXPECTED DROP/COLLAPSE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23391974 ↗
  • MalfunctionApr 28, 2025Unintended System Motion; Unintended System Motion

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED UN-COMMANDED MOTION OF THE ELECTRONIC POSITIONING FUNCTIONS. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21922036 ↗
  • MalfunctionApr 28, 2025Device Fell; Device Fell

    THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED LITTER/LIFT UNEXPECTED DROP/COLLAPSE OR STIRRUPS/CALF SUPPORT UNEXPECTED DROP/COLLAPSE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21921783 ↗
  • MalfunctionApr 28, 2025Positioning Failure; Positioning Failure

    THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FOOT SECTION DOES NOT LATCH/LOCK (FALSE LATCH). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21921498 ↗
  • MalfunctionApr 28, 2025Sharp Edges; Sharp Edges

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE SHARP METAL EDGES. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21921497 ↗
  • MalfunctionApr 28, 2025Mechanical Problem; Mechanical Problem

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED REDUCED/INADEQUATE BRAKE FORCE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21920686 ↗
  • MalfunctionJan 30, 2025Unintended System Motion; Unintended System Motion

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED UN-COMMANDED MOTION OF THE ELECTRONIC POSITIONING SYSTEMS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21277786 ↗
  • MalfunctionJan 28, 2025Sharp Edges; Sharp Edges

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21252359 ↗
  • MalfunctionJan 28, 2025Positioning Failure; Positioning Failure

    THIS REPORT SUMMARIZES 9 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED A FALSE LATCH OF THE FOOT SECTION. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21252196 ↗
  • MalfunctionJan 28, 2025Mechanical Problem; Mechanical Problem

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED REDUCED BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21252193 ↗
  • MalfunctionOct 29, 2024Device Fell; Device Fell

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED STIRRUPS/CALF SUPPORT UNEXPECTED DROP/COLLAPSE . THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20556457 ↗
  • MalfunctionOct 29, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    NO NEW INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20556456 ↗
  • MalfunctionOct 29, 2024Sharp Edges; Sharp Edges

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20556453 ↗
  • MalfunctionOct 29, 2024Mechanical Problem; Mechanical Problem

    THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED REDUCED/INADEQUATE BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20556237 ↗
  • MalfunctionOct 29, 2024Unintended System Motion; Unintended System Motion

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UN-COMMANDED MOTION OF THE ELECTRONIC POSITIONING FUNCTIONS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20556203 ↗
  • MalfunctionOct 29, 2024Positioning Failure; Positioning Failure

    THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FOOT SECTION DOES NOT LATCH/LOCK. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20556189 ↗
  • MalfunctionOct 29, 2024Positioning Failure; Electrical /Electronic Property Problem; Positioning Failure; Electrical /Electronic Property Problem

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE AC CURRENT AND FOOT SECTION DOES NOT LATCH/LOCK. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20556184 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K950889. One submission often covers many models, so check the product and lot details in each record.

  • Z-0793-05 · Mar 31, 2005 · Terminated
    Stryker brand Birthing Bed; Model 4701.
  • Z-0526-04 · Jan 26, 2004 · Terminated
    Stryker brand Firstcare Ultra Maternity bed and Stryker brand Adel Maternity bed, 220 volt, model 5012, with night light.
  • Z-0525-04 · Jan 26, 2004 · Terminated
    Stryker brand Firstcare Ultra Maternity bed, model 5010, with night light.
  • Z-0524-04 · Jan 26, 2004 · Terminated
    Stryker brand Adel maternity bed, model 4700, with night light.

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.