Facility

PENLON LTD.

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

Key facts

1recalls · worst Class II

3inspections · worst VAI

—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)	3002807907
Establishment type	Manufacture Medical Device
Location	ABINGDON SCIENCE PARK ABINGDON Oxfordshire, GB OX14 3NB
Registration status	Active · expires 2026
Parent company	PENLON LTD. (owner-operator 9029886)
Brand names	SIGMA DELTA VAPORIZER; SIGMA DELTA MRI VAPORIZER

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Vaporizer, Anesthesia, Non-Heated
Product code CAD (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5880

Recalls & enforcement

Class IITerminated2013-05-14
It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the vaporizer. Penlon Ltd has updated the Installation and daily Pre-Use Check sections of the User Ma…

FDA inspections (3)

NAI2024-12-12
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2022-07-14
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2018-09-13
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.

All facilities operated by PENLON LTD.

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. “PENLON LTD. (FEI 3002807907) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807907-penlon-ltd/

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