Facility

LAERDAL MEDICAL A/S

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

Key facts

4recalls · worst Class II

1inspections · worst NAI

—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)	3002807435
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	Seehusens gate 1 STAVANGER Rogaland, NO 4024
Registration status	Active · expires 2026
Parent company	LAERDAL MEDICAL A/S (owner-operator 9038993)
Brand names	NeoNatalie Resuscitator; NeoNatalie Complete Kit

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

Ventilator, Emergency, Manual (Resuscitator)
Product code BTM (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5915

Recalls & enforcement

Class IIOngoing2026-01-13
units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
Class IITerminated2020-12-18
Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the us…
Class IITerminated2017-08-31
A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms.
Class IITerminated2017-01-08
The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.

FDA inspections (1)

NAI2016-11-10
No Action Indicated · Compliance: Devices

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. “LAERDAL MEDICAL A/S (FEI 3002807435) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807435-laerdal-medical-a-s/

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