CLASS II ONGOING Device recall · Reported 23 Dec 2020 · FDA Enforcement Report
Microsurgical Operating Room Tables;7300BX (18-351-70) recalled
Mizuho America is recalling Microsurgical Operating Room Tables;7300BX (18-351-70), distributed in 9 states. The recall was initiated on 11 Sep 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0567-2021
- FDA event ID
- 85442
- Recalling firm
- Mizuho America, Union City, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Sep 2019
- FDA classified
- 14 Dec 2020
- Reported
- 23 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 11 Sep 2019 | Recall initiated by company | |
| 14 Dec 2020 | Classified by FDA | +460 days |
| 23 Dec 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.
Product as listed by the FDA
Microsurgical Operating Room Tables;7300BX (18-351-70).
Where it was distributed
US: AZ, CA, FL, MO, NC, OH, PA, TX, and WI. OUS: Greece, Israel, Japan, and Ukraine.
ArizonaCaliforniaFloridaMissouriNorth CarolinaOhioPennsylvaniaTexasWisconsin
Questions about this recall
Why was it recalled?
Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.
Which lots are affected?
Tilt Movement-Leaking Valve (7300BX-18-351-70) serial numbers: MUC-20163-0001, MUC-2016Z-0002, MUC-2016Z-0003, MUC-20177-0005, MUC-20177-0007, MUC-20177-0008, MUC-20177-0009, MUC-20189-0017 & MUC-2018Y-0018. Unintended movement due to infrared signal errors (7300BX-18-351-70) serial numbers: MUC-20163-0001, MUC-2016Z-0002, MUC-2016Z-0003, MUC-20177-0005, MUC-20177-0007, MUC-20177-0008, MUC-20177-0009, MUC-20189-0017, MUC-2018Y-0018 & MUC-2018Y-0019.
Where was it sold?
US: AZ, CA, FL, MO, NC, OH, PA, TX, and WI. OUS: Greece, Israel, Japan, and Ukraine.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85442| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Microsurgical Operating Room Tables;7300B (18-350-70) recalled | Mizuho America | Other | 9 states |
More recalls from Mizuho America
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Microsurgical Operating Room Tables;7300B (18-350-70) recalled | Mizuho America | Other | 9 states |
| Device | CLASS II | Mizuho Sugita Titanium Standard Aneurysm Clip II recalled | Mizuho America | Other | Nationwide |
| Device | CLASS II | Mizuho Sugita Titanium Standard Aneurysm Clip II recalled | Mizuho America | Other | Nationwide |
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