CLASS III Device recall · Reported 8 Jan 2020 · FDA Enforcement Report

Specular Microscope recalled by Nidek

Nidek is recalling Nidek Specular Microscope, distributed nationwide in the US. The recall was initiated on 25 Feb 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesSerial numbers 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, and 170001.

Quantity recalled13 devices

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-0771-2020
FDA event ID: 84112
Recalling firm: Nidek, Fremont, CA
Classification: Class III
Status: Terminated
Recall initiated: 25 Feb 2019
FDA classified: 2 Jan 2020
Reported: 8 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

25 Feb 2019	Recall initiated by company
2 Jan 2020	Classified by FDA	+311 days
8 Jan 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)

Product as listed by the FDA

NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.

Where it was distributed

US Nationwide distribution in the states of AZ, CA, IL, KS, MD, NJ, NY, PA, SC, and VA, as well as PR.

Nationwide Arizona California Illinois Kansas Maryland New Jersey New York Pennsylvania Puerto Rico South Carolina Virginia

Questions about this recall

Is Specular Microscope recalled?

Yes. Nidek recalled Specular Microscope on 25 Feb 2019. The recall is Class III and its status is Terminated. Recall number Z-0771-2020.

Why was it recalled?

The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)

Which lots are affected?

Serial numbers 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, and 170001.

Where was it sold?

US Nationwide distribution in the states of AZ, CA, IL, KS, MD, NJ, NY, PA, SC, and VA, as well as PR.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Nidek

All 21

Reported	Class	Recall	Company	Reason	Where
26 Dec 2018Device	CLASS III	RT-5100 Refractor, a component of the Epic-5100 System recalled by Nidek	Nidek	Other	FL
18 Apr 2018Device	CLASS II	Auto REF/Keratometer Ark-1s recalled by Nidek	Nidek	Other	26 states
29 Mar 2017Device	CLASS II	Final Fit recalled by Nidek	Nidek	Device Malfunction	Nationwide
7 Sep 2016Device	CLASS II	Specular Microscope Cem recalled by Nidek	Nidek	Device Malfunction	18 states
24 Aug 2016Device	CLASS II	Optical Biometer Al-Scan recalled by Nidek	Nidek	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide