Facility

HENKE SASS WOLF OF AMERICA, INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000120548
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	135 Schofield Ave DUDLEY, MA, US 01571
Registration status	Active · expires 2026
Parent company	HENKE-SASS WOLF, GMBH. (owner-operator 8010418)
Brand names	XION Otoscope

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Otoscope
Product code ERA (opens in a new tab) · Class I · Ear, Nose, Throat · 21 CFR 874.4770

Recalls & enforcement

Class IIOngoing2023-07-27
Sterile barrier might be damaged compromising the sterility of the device.

FDA inspections (3)

VAI2025-09-16
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2021-08-11
Voluntary Action Indicated · Compliance: Devices · citations posted
VAI2019-03-25
Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “HENKE SASS WOLF OF AMERICA, INC. (FEI 1000120548) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000120548-henke-sass-wolf-of-america-inc/

Not open yet

Alerts for HENKE SASS WOLF OF AMERICA, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.