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Welch Allyn, Inc.

United States·US-MF-000013394

Last updated September 17, 2026

What Welch Allyn, Inc. makes

Welch Allyn, Inc. manufactures professional multichannel electrocardiographs, reusable blood pressure cuffs, and cardiopulmonary stress testing systems. Their portfolio also includes general-purpose and centralized bedside monitors for clinical use, as well as ophthalmic and otologic diagnostic tools. The company produces monitoring systems for multiple physiological parameters and patient health record software applications.

The company’s devices are classified under Class I and Class II regulations, with listings in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. Welch Allyn, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 4341, State Street Road, Skaneateles Falls, New York, United States
Website: www.baxter.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 484-949-1130
PRRC Contact: —
EUDAMED SRN: US-MF-000013394
FDA FEI Number: 1316463
DUNS Number: 198227881

Catalogue (5347)

Page 107 of 107

Device	Model / Reference	Registries	Class	Status
Welch Allyn Harvey Elite Stethoscope	5079-122S	EUDAMEDFDA UDI	Class I	Active
FlexiPort	REUSE-08-2TPE	EUDAMEDFDA UDI	Class I	Active
Welch Allyn	47-15-389	EUDAMED	Class I	Active
FlexiPort	REUSE-11L-1MQ	EUDAMEDFDA UDI	Class I	Active
FlexiPort	REUSE-06-1TP	EUDAMEDFDA UDI	Class I	Active
KleenSpec	80000	EUDAMEDFDA UDI	Class I	Active
FlexiPort	VINYL-07-2MQ	EUDAMEDFDA UDI	Class I	Active
FlexiPort	VlNYL-09-2BVC	EUDAMEDFDA UDI	Class I	Active
FlexiPort	REUSE-08-2TP	EUDAMEDFDA UDI	Class I	Active
FlexiPort	REUSE-07-2BVC	EUDAMEDFDA UDI	Class I	Active
FlexiPort	REUSE-06-1MQ	EUDAMEDFDA UDI	Class I	Active
FlexiPort	VINYL-12L-1MQ	EUDAMEDFDA UDI	Class I	Active
Welch Allyn Harvey Stethoscope	5079-322S	EUDAMEDFDA UDI	Class I	Active
Welch Allyn	21501	EUDAMEDFDA UDI	Class I	Active
FlexiPort	SOFT-12L-1TP	EUDAMEDFDA UDI	Class I	Active
FlexiPort	VINYL-11-1HP	EUDAMEDFDA UDI	Class I	Active
FlexiPort	VINYL-12-2BVC	EUDAMEDFDA UDI	Class I	Active
FlexiPort	REUSE-10-2TP	EUDAMEDFDA UDI	Class I	Active
FlexiPort	REUSE-08-2MQ	EUDAMEDFDA UDI	Class I	Active
Welch Allyn Laryngoscope Handle	60715	EUDAMEDFDA UDI	Class I	Active
Welch Allyn	NEO-4-1	EUDAMEDFDA UDI	Class I	Active
Welch Allyn	5082-02	EUDAMEDFDA UDI	Class I	Active
Welch Allyn	4500-02	EUDAMEDFDA UDI	Class I	Active
FlexiPort	SOFT-12-2MQ	EUDAMEDFDA UDI	Class I	Active
FlexiPort	REUSE-08-2BV	EUDAMEDFDA UDI	Class I	Active
Welch Allyn	5082-45	EUDAMEDFDA UDI	Class I	Active
Welch Allyn Laryngoscope Miller Fiber Optic Blade	68063	EUDAMEDFDA UDI	Class I	Active
Welch Allyn Laryngoscope Miller Standard Blade	68043	EUDAMEDFDA UDI	Class I	Active
FlexiPort	REUSE-11-2BVC	EUDAMEDFDA UDI	Class I	Active
FlexiPort	SOFT-08-2BV	EUDAMEDFDA UDI	Class I	Active
Welch Allyn	23804	EUDAMEDFDA UDI	Class I	Active
FlexiPort	VINYL-12	EUDAMEDFDA UDI	Class I	Active
FlexiPort	SOFT-11L-1TPE	EUDAMEDFDA UDI	Class I	Active
FlexiPort	SOFT-08-2MF	EUDAMEDFDA UDI	Class I	Active
Braun Thermoscan	06000-150	EUDAMED	Class I	Active
Welch Allyn	24330	EUDAMEDFDA UDI	Class I	Active
PanOptic	118-2	EUDAMEDFDA UDI	Class I	Active
Welch Allyn Laryngoscopes MacIntosh Fiber Optic Blade	69063	EUDAMEDFDA UDI	Class I	Active
Welch Allyn Laryngoscope English MacIntosh Standard Blade	69243	EUDAMEDFDA UDI	Class I	Active
Welch Allyn	5200-01	EUDAMEDFDA UDI	Class I	Active
Welch Allyn	12880-BLU	EUDAMEDFDA UDI	Class I	Active
FlexiPort	REUSE-10-2BV	EUDAMEDFDA UDI	Class I	Active
Welch Allyn	22005	EUDAMEDFDA UDI	Class I	Active
FlexiPort	REUSE-12-1TP	EUDAMEDFDA UDI	Class I	Active
FlexiPort	VINYL-10-2BVC	EUDAMEDFDA UDI	Class I	Active
FlexiPort	REUSE-12L-2BVC	EUDAMEDFDA UDI	Class I	Active
Welch Allyn Professional Stethoscope	5079-135	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Welch Allyn Limited IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (17)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Welch Allyn, Inc. has 17 recall records initiated between October 27, 2003, and July 20, 2021. The records include open, classified, and terminated statuses, with reasons involving potential device malfunctions such as fluid ingress risks leading to overheating or electrical shorts, mechanical errors affecting cuff placement or calibration, battery charging defects, incorrect power cord connections, and manufacturing deficiencies.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jul 20, 2021	Z-2482-2021	—	open, classified	If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient
Apr 22, 2021	Z-1672-2021	—	terminated	Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
Apr 22, 2021	Z-1673-2021	—	terminated	Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
Feb 27, 2017	Z-1777-2017	—	terminated	A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. This potential defect resides with the device, not the battery. The over-voltage condition can result in high NiMH battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components.
Oct 2, 2015	Z-0169-2016	—	terminated	The firm became aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the illuminator low voltage transformer power cord which is supplied with the illuminator. This may result in a shattered lamp bulb and a potential electric shock hazard.
Mar 1, 2004	Z-0748-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0752-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-753-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0749-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0751-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0755-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0756-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0754-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0750-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0757-04	—	terminated	GMP deficiencies
Dec 30, 2003	Z-0354-04	—	terminated	Mechanical setting errors that result in calibration errors.
Oct 27, 2003	Z-0244-04	—	terminated	Incorrect location of inflatable portion of cuff that may result in cuff falling off patient's arm, error code when used with patient monitor, or an inaccurate reading.