Facility

Karl Storz Endoscopy-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)	3007475226
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	2151 E. Grand Avenue El Segundo, CA, US 90245
Registration status	Active · expires 2026
Parent company	KARL STORZ SE & CO KG (owner-operator 8010119)
Brand names	LAPAROMAT Laparoscopic Suction

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (2)

Pump, Portable, Aspiration (Manual Or Powered)
Product code BTA (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4780
Laparoscope, General & Plastic Surgery
Product code GCJ (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.

FDA inspections (3)

VAI2024-09-12
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2020-08-20
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2018-04-16
No Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act

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 Endoscopy-America, Inc. (FEI 3007475226) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007475226-karl-storz-endoscopy-america-inc/

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