Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2132-2014·Announced 2014-08-06

Nidek MC-500 Laser Photocoagulator Recalled for Missing Aperture Label

Nidek Inc. is recalling 29 MC-500 Multicolor Laser Photocoagulators because the laser aperture label was not affixed to the devices prior to shipment.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The missing label is a documentation and safety marking issue rather than a functional defect causing direct injury, fitting the Moderate severity criteria for labeling errors.

Plain-English summary

Nidek Inc. is recalling 29 units of the MC-500 Multicolor Laser Photocoagulator, a medical device used for ophthalmic and retinal procedures. The recall was initiated because the laser aperture label was not affixed to the devices prior to shipment in the United States.

The affected devices were distributed nationwide, including in Illinois, Nebraska, New York, New Hampshire, Colorado, Michigan, Texas, California, Pennsylvania, Florida, Kansas, Utah, Minnesota, Wisconsin, Missouri, and Oregon. The recall involves 29 units, of which 26 have already been re-labeled. The specific part number is 173530U20, and the affected serial numbers are listed in the official recall documentation.

Healthcare providers and consumers should check their inventory for these specific serial numbers. If a device is found without the required laser aperture label, it should be removed from service and the manufacturer contacted for instructions on re-labeling or replacement.

The recalled product

Product: MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Manufacturer: Nidek Inc
Category: Medical Device — Ophthalmic Equipment
Hazard: mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Part number: 173530U20 Serial numbers: 50010
50127
50136
50277
50310
50311
50330
50331
50357. 50358
50359
50382
50383
50408. 50417
50418
50426
50439
50445
50446
50471
50514

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Same manufacturer · Nidek Inc

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Same hazard · mis labeling