Welch Allyn KleenSpec Corded Illumination System — Class II medical device recall Z-0169-2016

Terminated recall by Welch Allyn Inc, reported 2015-11-04, distributed nationwide. The firm became aware that the KleenSpec¿ 788 Corded Illuminator has the potential to be incorrectly connected

Recall number	`Z-0169-2016`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Welch Allyn Inc, Skaneateles Falls, NY, United States
Recall initiated	2015-10-02
Classified	2015-10-27
Reported by FDA	2015-11-04
Terminated	2018-05-23
Distributed	Nationwide (US)
Countries outside the US	AE, AU, BE, BH, BM, BS, CA, CN, CY, CZ, DE, DK, EG, ES, FR, GB, GR, GT, IL, IN, IS, JP, KE, KW, LK, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PL, RS, RU, SA, SG, TH, TR, ZA
Model numbers	`73410`, `73412`, `73414`, `73416`, `78800`, `78810`, `78812`, `78814`, `78816`, `78X`, `901070`

Product

Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLY

Reason for recall

The firm became aware that the KleenSpec¿ 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the illuminator low voltage transformer power cord which is supplied with the illuminator. This may result in a shattered lamp bulb and a potential electric shock hazard.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0169-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.