RegWardenFDA facility compliance records
Company

Spiegelberg GmbH & Co. KG

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

Recalls by year

FDA actions on record by year2009: 1 recalls1’09’10’11’12’13’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (1)

Registered facilities (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…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Spiegelberg GmbH & Co. KG — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10037562-spiegelberg-gmbh-co-kg/

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