1st Tier Unilet · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2025-01-23	NAI	No action indicated	Owen Mumford Sdn. Bhd.	0
2022-08-25	NAI	No action indicated	Owen Mumford Sdn. Bhd.	0
2019-03-05	NAI	No action indicated	Owen Mumford USA, Inc.	0
2019-03-05	NAI	No action indicated	Owen Mumford USA, Inc.	0
2016-05-12	NAI	No action indicated	Owen Mumford Ltd.	0
2016-05-12	NAI	No action indicated	Owen Mumford Ltd.	0
2015-03-26	OAI	Official action indicated	Owen Mumfordltd.	0
2014-10-31	VAI	Voluntary action indicated	Owen Mumford USA, Inc.	1
2014-10-31	VAI	Voluntary action indicated	Owen Mumford USA, Inc.	1
2014-06-04	WL	Warning Letter	Owen Mumford USA, Inc.	—
2014-06-04	WL	Warning Letter	Owen Mumford USA, Inc.	—
2013-12-12	OAI	Official action indicated	Owen Mumford USA, Inc.	6
2013-12-12	OAI	Official action indicated	Owen Mumford USA, Inc.	6
2011-08-10	VAI	Voluntary action indicated	Owen Mumford USA, Inc.	7
2011-08-10	VAI	Voluntary action indicated	Owen Mumford USA, Inc.	7

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