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Machida Endoscope Co., Ltd. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection VAI · May 28, 2026
No warning letters matched by name

Inspections 3

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 1 Latest Mar 13, 2000

Machida Endoscope Co., Ltd. has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Machida Endoscope Co., Ltd." is on file.

What these totals cover: FDA records filed under the name "Machida Endoscope Co., Ltd." and its spelling variant "Machida Endoscope Co".

Latest inspection: May 28, 2026 · VAI
Latest 510(k): Mar 13, 2000

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	1	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Machida Endoscope Co., Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Machida Endoscope Co., Ltd.: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	1	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

3 inspections from Aug 23, 2017 to May 28, 2026.

Date	Site	Product	Classification	FEI
May 28, 2026	Abiko, Japan	Devices	Voluntary Action Indicated (VAI)	3002807522
Dec 7, 2023	Abiko, Japan	Devices	Voluntary Action Indicated (VAI)	3002807522
Aug 23, 2017	Abiko, Japan	Devices	No Action Indicated (NAI)	3002807522

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002807522	Abiko, Japan	3	May 28, 2026

Recent 510(k) clearances

1 510(k) clearance on Mar 13, 2000.

K-Number	Device	Date
K993568	MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L	Mar 13, 2000

Machida Endoscope Co., Ltd. and the FDA: common questions

Has Machida Endoscope Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Machida Endoscope Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Machida Endoscope Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Machida Endoscope Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Machida Endoscope Co., Ltd.?

The most recent FDA inspection on file ended May 28, 2026 at Abiko, Japan and was classified VAI. FDA has 3 inspections of Machida Endoscope Co., Ltd. on file.

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