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Mizuho OSI FDA Record

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

Mizuho OSI has 6 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Mizuho OSI" is on file.

What these totals cover: FDA records filed under the name "Mizuho OSI".

Latest recall: Z-1573-2022 · Class II · Jul 29, 2021
Latest inspection: Feb 25, 2016 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	6	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	4	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

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

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	2	0
2020	0	0	0	0	0
2019	0	0	0	1	0
2018	0	0	0	0	0
2017	0	0	0	1	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 recalls

6 recall records from Dec 17, 2012 to Jul 29, 2021.

Number	Class	Product	Date
Z-1573-2022	Class II	HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144	Jul 29, 2021
Z-1293-2021	Class II	Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit…	Feb 8, 2021
Z-0091-2021	Class II	Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF…	Oct 14, 2019
Z-1867-2017	Class II	216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G…	Mar 28, 2017
Z-0792-2016	Class II	Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP…	Dec 14, 2015
Z-0810-2013	Class II	Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.	Dec 17, 2012

Recent FDA inspections

4 inspections from Jun 2, 2010 to Feb 25, 2016.

Date	Site	Product	Classification	FEI
Feb 25, 2016	Union City, CA	Devices	No Action Indicated (NAI)	2921578
Sep 25, 2013	Union City, CA	Devices	Voluntary Action Indicated (VAI)	2921578
Sep 11, 2012	Union City, CA	Devices	Voluntary Action Indicated (VAI)	2921578
Jun 2, 2010	Union City, CA	Devices	No Action Indicated (NAI)	2921578

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 2921578	Union City, CA	4	Feb 25, 2016

Mizuho OSI and the FDA: common questions

Has Mizuho OSI received an FDA warning letter?

No FDA warning letter addressed to the name "Mizuho OSI" 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 Mizuho OSI received an FDA Form 483?

FDA has not published a Form 483 for "Mizuho OSI" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Mizuho OSI?

The most recent FDA inspection on file ended Feb 25, 2016 at Union City, CA and was classified NAI. FDA has 4 inspections of Mizuho OSI on file.

Has Mizuho OSI had an FDA recall?

Yes. Mizuho OSI has 6 FDA recalls on record. The most recent started Jul 29, 2021.

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