MAQUET GMBH FDA Inspection Record

FEI 1841 · Inspections, Form 483s, warning letters and import refusals

MAQUET GMBH is an FDA-registered facility (FEI 1841) located in RASTATT Baden-Wurttemberg, DE. RegDataLab tracks 1 FDA inspection at this facility.

What FDA found at this site

Latest inspection
Nov 19, 2015: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
1, latest Jul 14, 2025
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Nov 19, 2015Voluntary Action Indicated (VAI)Lack of or inadequate In-process acceptance procedures (21 CFR 820.80(c))
Investigation of device failures (21 CFR 820.198(c))
Documented evaluation (21 CFR 820.50(a)(1))

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Jul 14, 2025Class IIZ-2420-2025Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4)…
Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF)…

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
MAQUET GMBH
Location
RASTATT Baden-Wurttemberg (DE)
Source
device

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.