RegWardenFDA facility compliance records
Facility

SPIEGELBERG GmbH & Co. KG

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

Activity by year

FDA actions on record by year2009: 1 recalls; 2016: 1 inspections1’09’10’11’12’13’14’151’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

  • Class IITerminated2009-12-29
    In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to 20 mmHg. The observed measurement error was particularly at the lowest end o…

FDA inspections (1)

  • OAI2016-02-04
    Official 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.

Related

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. “SPIEGELBERG GmbH & Co. KG (FEI 3002108226) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002108226-spiegelberg-gmbh-co-kg/

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