Facility

KARL STORZ SE & CO. KG

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

Key facts

1recalls · worst Class II

2inspections · worst OAI

—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)	3002808268
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	Dr.-Karl-Storz-Str. 11 TUTTLINGEN Baden-Wurttemberg, DE 78532
Registration status	Active · expires 2026
Parent company	KARL STORZ SE & CO KG (owner-operator 8010119)
Brand names	KARL STORZ MODEL 28200C

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Product code HWE (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4820

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 (2)

OAI2022-10-13
Official Action Indicated · Compliance: Devices
VAI2020-03-12
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: 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 SE & CO. KG (FEI 3002808268) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002808268-karl-storz-se-co-kg/

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