Nara 4402Recalls & reported problems
Stryker Corporation · Class 2
Quick summary
This Stryker Nara hospital bassinet has 80 adverse event reports mostly describing malfunctions, such as sharp metal edges, the basket falling or failing to tilt, and an overly soft mattress. There are no deaths and 1 injury. No recalls name this device.
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
- 80
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 07613327261615), received between Mar 7, 2018 and Jul 28, 2026 — classified as 1 injury, 79 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (30 reports).
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
Most reported problems
Device problems
- Inflation Problem30
- Device Operates Differently Than Expected15
- Sharp Edges9
- Material Deformation7
- Material Too Soft/Flexible5
- Nonstandard Device4
- Device Fell3
- Inadequacy of Device Shape and/or Size2
Patient problems
- No Known Impact Or Consequence To Patient38
- No Clinical Signs, Symptoms or Conditions19
- No Code Available10
- No Patient Involvement8
- No Information2
- Deformity/ Disfigurement1
- Injury1
- Laceration(s)1
Recent adverse event reports
The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Material Too Soft/Flexible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060199 ↗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 24189129 ↗MalfunctionOct 27, 2025Material Too Soft/Flexible; Material Too Soft/Flexible
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23391970 ↗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 23391969 ↗MalfunctionJan 28, 2025Device Fell; Device Fell
THIS REPORT SUMMARIZES 9 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED THE BASSINET BASKET FALLS OFF, FALLS FROM TILT POSITION, OR THAT THE BASKET COULD NOT BE TILTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21252197 ↗MalfunctionOct 29, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED MATTRESS IS TOO SOFT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20556187 ↗MalfunctionJul 29, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED MATTRESS IS TOO SOFT; TOO MUCH MATTRESS IMMERSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19850109 ↗MalfunctionApr 23, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
THIS REPORT SUMMARIZES 0 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED MATTRESS IS TOO SOFT; TOO MUCH MATTRESS IMMERSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19163122 ↗MalfunctionOct 23, 2023Sharp 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 17990340 ↗MalfunctionJul 18, 2023Material Integrity Problem; Material Integrity Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED A BROKEN TUB/BASKET. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17343976 ↗MalfunctionApr 25, 2023Device Fell; Device Fell
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED BASKET FALLS OFF OF BASSINET. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16811332 ↗MalfunctionApr 25, 2023Material Separation; Material Separation
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED BASKET/TUB STRUCTURE IS COMPROMISED LEADING TO BREAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16811330 ↗MalfunctionJul 27, 2022Sharp Edges; Sharp Edges
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15113985 ↗MalfunctionApr 26, 2022Device Fell; Device Fell
THIS REPORT SUMMARIZES 7 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED THE BASKET FALLS FROM A TILT POSITION OR CANNOT BE TILTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14209250 ↗MalfunctionApr 25, 2022Material Separation; Material Separation
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED THE BASSINET TUB WAS STRUCTURALLY COMPROMISED LEADING TO A BREAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14194751 ↗MalfunctionAug 9, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A NURSE FOUND A PEDIATRIC PATIENT LYING ON ITS SIDE IN A BASSINET. THE USER FACILITY STATED THE MATTRESS APPEARED TO HAVE A DIVOT IN THE MIDDLE, CAUSING THE PATIENT TO FLIP FROM THEIR BACK TO THEIR SIDE. AS A RESULT, THE PATIENT WAS FOUND TO HAVE A SLIGHTLY DEFORMED HEAD AND WAS TREATED WITH A HELMET.
Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions
MAUDE report 12295140 ↗MalfunctionJul 27, 2021Material Integrity Problem; Material Integrity Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED A BROKEN TUB. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12233989 ↗MalfunctionApr 23, 2021Sharp Edges; Sharp Edges
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THERE ARE ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11715670 ↗MalfunctionOct 27, 2020Sharp Edges; Sharp Edges
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THERE WERE ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10743654 ↗MalfunctionJul 22, 2020Sharp Edges; Sharp Edges
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE HAD ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10310969 ↗MalfunctionJan 28, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE GAP ON THE SIDE OF THE MATTRESS WAS TOO BIG. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9638813 ↗MalfunctionJan 27, 2020Sharp Edges; Sharp Edges
THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS, WHERE IT WAS REPORTED THERE WERE ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9634052 ↗MalfunctionJan 16, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED BY THE CUSTOMER THAT THEIR IS A GAP BETWEEN THE MATTRESS AND NARA. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 9597457 ↗MalfunctionOct 25, 2019Sharp Edges; Sharp Edges
THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE HAD ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9237966 ↗MalfunctionJul 3, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED VIA U.S. CONSUMER PRODUCT SAFETY COMMISSION REPORT THAT A CAREGIVER WAS INJURED BY A STRYKER NARA BASSINET WHEN IT ROLLED INTO THE BACK OF HER LEFT ANKLE, WITH THE CAREGIVER REPORTEDLY SUSTAINING A 5 INCH LONG BY 3 INCH WIDE LACERATION THAT REQUIRED STITCHES. IT IS ALSO REPORTED THAT THE INJURY RESULTED IN A NEUROMA, NEUROPATHY, NERVE DAMAGE AS WELL AS A CONTRACTURE ON THE CAREGIVER'S LEG.
Patient problems: Laceration(s); Nerve Damage; Neuropathy
MAUDE report 8758498 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.