Facility

KARL STORZ ENDOVISION, INC.

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

Key facts

1recalls · worst Class II

4inspections · 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)	1221826
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	91 Carpenter Hill Rd CHARLTON, MA, US 01507
Registration status	Active · expires 2026
Parent company	KARL STORZ SE & CO KG (owner-operator 8010119)
Brand names	CMOS Video Rhino Laryngoscope

Activity by year

Recalls (1)
Inspections (4)

Devices registered here (1)

Nasopharyngoscope (Flexible Or Rigid)
Product code EOB (opens in a new tab) · Class II · Ear, Nose, Throat · 21 CFR 874.4760

Recalls & enforcement

Class IITerminated2016-02-29
Endoscope cleaning brush 11276CL may not fit resulting in an inability to insert the brush in to the channel of the intended endoscope or to completely pass it through such channel.

FDA inspections (4)

VAI2022-06-14
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2021-09-17
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-06-14
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2016-12-20
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. “KARL STORZ ENDOVISION, INC. (FEI 1221826) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1221826-karl-storz-endovision-inc/

Not open yet

Alerts for KARL STORZ ENDOVISION, 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.