EasySuite 4K Integrated Operating Room System
Medical device recall Z-2233-2024. Published in FDA’s Enforcement Report on Jul 10, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 10, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 227 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical current flowing to the earth is within standard limits
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights.
227 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: N/A Serial numbers: BZ-0000004 BZ-0000005 BZ-0000007 BZ-0000008 BZ-0000009 BZ-0000010 BZ-0000015 BZ-0000019 BZ-0000022 BZ-0000030 BZ-0000031 BZ-0000034 BZ-0000035 BZ-0000039 BZ-0000040 BZ-0000042 BZ-0000043 BZ-0000047 BZ-0000048…
Every code shown here, 1,992 characters
UDI-DI: N/A Serial numbers: BZ-0000004 BZ-0000005 BZ-0000007 BZ-0000008 BZ-0000009 BZ-0000010 BZ-0000015 BZ-0000019 BZ-0000022 BZ-0000030 BZ-0000031 BZ-0000034 BZ-0000035 BZ-0000039 BZ-0000040 BZ-0000042 BZ-0000043 BZ-0000047 BZ-0000048 BZ-0000049 BZ-0000050 BZ-0000051 BZ-0000052 BZ-0000056 BZ-0000057 BZ-0000058 BZ-0000059 BZ-0000060 BZ-0000061 BZ-0000062 BZ-0000063 BZ-0000064 BZ-0000065 BZ-0000066 BZ-0000067 BZ-0000068 BZ-0000069 BZ-0000074 BZ-0000075 BZ-0000076 BZ-0000077 BZ-0000079 BZ-0000080 BZ-0000081 BZ-0000082 BZ-0000083 BZ-0000085 BZ-0000086 BZ-0000087 BZ-0000088 BZ-0000089 BZ-0000090 BZ-0000091 BZ-0000092 BZ-0000096 BZ-0000099 BZ-0000103 BZ-0000104 BZ-0000105 BZ-0000106 BZ-0000108 BZ-0000111 BZ-0000112 BZ-0000113 BZ-0000114 BZ-0000116 BZ-0000117 BZ-0000118 BZ-0000140 BZ-0000141 BZ-0000142 BZ-200001 BZ-200005 BZ-200007 BZ-200011 BZ-200012 BZ-200013 BZ-200017 BZ-200018 BZ-200027 BZ-200028 BZ-200029 BZ-200030 BZ-200031 BZ-200032 BZ-200033 BZ-200034 BZ-200037 BZ-200038 BZ-200042 BZ-200070 BZ-200071 BZ-200132 BZ-200184 BZ-300001 BZ-300002 BZ-300003 BZ-300004 BZ-300005 BZ-300006 BZ-300008 BZ-300009 BZ-300011 BZ-300012 BZ-300013 BZ-300014 BZ-300019 BZ-300020 BZ-300025 BZ-600004 BZ-600050 BZ-600052 BZ-600053 BZ-600055 BZ-600056 BZ-600057 BZ-600060 BZ-600064 BZ-600065 BZ-600066 BZ-600067 BZ-600086 BZ-600087 BZ-600089 BZ-600090 BZ-600117 BZ-600119 BZ-600121 BZ-600146 BZ-600147 BZ-700001 FLX-200001 FLX-200003 FLX-200004 FLX-200008 FLX-200013 FLX-200014 FLX-200015 FLX-200016 FLX-200020 FLX-200021 FLX-200022 FLX-200023 FLX-200025 FLX-200026 FLX-200028 FLX-200029 FLX-200030 FLX-200032 FLX-200033 FLX-200034 FLX-200035 FLX-200037 FLX-200044 FLX-200053 FLX-200076 FLX-200078 FLX-200079 FLX-200083 FLX-200099 FLX-200105 FLX-200112 FLX-200122 FLX-200123 FLX-200126 FLX-200127 FLX-200128 FLX-200129 FLX-200137 FLX-200138 FLX-200139 FLX-200140 FLX-200142 FLX-200155 FLX-200156 FLX-200160 FLX-200172 FLX-200175 FLX-200184 FLX-200188 FLX-200191 FLX-200194 FLX-200197 FLX-200198…
FDA’s list runs to 2,443 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide and the countries of Germany, Hong Kong.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 24, 2024.
- FDA classified it on Jun 28, 2024.
- FDA’s Enforcement Report published it on Jul 10, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Olympus Corporation of the Americas, of Center Valley, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,443 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.