Welch Allyn, Inc.
4341 STATE STREET RD., Skaneateles Falls, NY, US
Registered product codes
53 product codes
Recent MDR events
1,011 on file
- WELCH ALLYN, INC.Jul 22, 2026Malfunction25905094
- OXIMETERJul 14, 2026MalfunctionMW5190700
- WELCH ALLYN CONNEX® SPOT MONITORJul 14, 2026MalfunctionMW5190701
- CUFF BP FLEXIPORT 11 SOFT DISP 25-34CMJun 22, 2026MalfunctionMW5189679
- CONTRACT EQ MM-HSCRIBE-DICOM MIDDLEWAREMay 15, 2026Malfunction1316463-2026-00038
- SPOT VISION SCREENER,W/CASE,PLUGB/USMay 15, 2026Malfunction1316463-2026-00039
- VS100 POWER SUPPLY SET/PLUGB/USMay 15, 2026Malfunction1316463-2026-00040
- WELCH ALLYN GREEN SERIES 777May 12, 2026Malfunction1316463-2026-00037
- CONNEX SPOT ACCY POWER MGMT STANDMay 8, 2026Malfunction1316463-2026-00036
- 4802D SCALE, 1GM, STD CRAD, NA_PCORDMay 7, 2026Malfunction1316463-2026-00035
Recalls
33 on file
- TerminatedApr 29, 2020
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
View FDA record ↗ - TerminatedApr 29, 2020
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
View FDA record ↗ - TerminatedApr 29, 2020
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
View FDA record ↗ - TerminatedApr 29, 2020
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
View FDA record ↗ - TerminatedApr 29, 2020
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
View FDA record ↗ - TerminatedApr 29, 2020
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
View FDA record ↗ - TerminatedApr 29, 2020
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
View FDA record ↗ - TerminatedApr 29, 2020
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
View FDA record ↗ - TerminatedApr 29, 2020
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
View FDA record ↗ - TerminatedApr 29, 2020
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
View FDA record ↗
Compliance history
Matched by FEI 1316463.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jan 9, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jan 9, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.100(a)Jan 9, 2026
Lack of or inadequate procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
9 on file
Top refusal reasons
Compare to industry ↗- Division of West Coast Imports (DWCI)Jul 23, 2025
77ETY \ TESTER, AUDITORY IMPEDANCE
- Division of Southwest Imports (DSWI)Jun 4, 2025
77ERA \ OTOSCOPE
- Division of Southwest Imports (DSWI)Jun 4, 2025
86HKM \ RETINOSCOPE, BATTERY-POWERED
- Division of Southwest Imports (DSWI)Jun 4, 2025
77ERA \ OTOSCOPE
- Division of Southwest Imports (DSWI)Jun 4, 2025
86HLI \ OPHTHALMOSCOPE, AC-POWERED
- Division of West Coast Imports (DWCI)Feb 5, 2025
74DPS \ ELECTROCARDIOGRAPH
- Division of West Coast Imports (DWCI)Sep 19, 2024
77ETY \ TESTER, AUDITORY IMPEDANCE
- Division of Southeast Imports (DSEI)May 22, 2024
86HKM \ RETINOSCOPE, BATTERY-POWERED
- Division of West Coast Imports (DWCI)Dec 13, 2023
74MWI \ MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)