Facility

KARL STORZ Endovision, Inc.

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3032429484
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	1376 W Central St Ste 50 Franklin, MA, US 02038
Registration status	Active · expires 2026
Parent company	KARL STORZ SE & CO KG (owner-operator 8010119)
Brand names	SSU Flexible Video-Uretero-Renoscope

Activity by year

Recalls (1)

Devices registered here (1)

Ureteroscope And Accessories, Flexible/Rigid
Product code FGB (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500

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.

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 3032429484) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3032429484-karl-storz-endovision-inc/

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