Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 4, 2015
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
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Welch Allyn Inc recalled Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model… - a moderate-severity action.
Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model… was recalled by Welch Allyn Inc in November 4, 2015. Reason: The firm became aware that the KleenSpec¿ 788 Corded Illuminator has the potential to be incorrectly connecte…. Check the official notice for the remedy. Verify recall #Z-0169-2016 with the FDA Devices before acting.
The recall
Welch Allyn Inc issued this moderate-severity FDA Devices recall-The firm became aware that the KleenSpec¿ 788 Corded Illuminator has the potential to be incorrectly connecte….
- Moderate
- severity level
- Class II
- classification
- November 4, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0169-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0169-2016) was formally reported on November 4, 2015, with the manufacturer initiating the action on October 2, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Welch Allyn Inc is listed as the recalling firm, operating out of Skaneateles Falls, NY. Federal records list the affected scope as Domestic: 179,401 units, Foreign: 15,063 units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Bahamas, Bahrain, Belgium, Bermuda, Cambodia, Canada, Czech Republic, China, Cyprus, Denmark, Egypt, France, Germany, Great Britai…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Domestic: 179,401 units, Foreign: 15,063 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0169-2016 |
| Date reported | November 4, 2015 |
| Date initiated | October 2, 2015 |
| Recalling firm | Welch Allyn Inc |
| Firm location | Skaneateles Falls, NY |
| Affected scope | Domestic: 179,401 units, Foreign: 15,063 units |
| Distribution | Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Bahamas, Bahrain, Belgium, Bermuda, Cambodia, Canada, Czech Republic, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Guam, Gua… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0169-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Welch Allyn Inc. Units affected: Domestic: 179,401 units, Foreign: 15,063 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 4, 2015. Severity: Moderate. Recall number: Z-0169-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Bahamas, Bahrain, Belgium, Bermuda, Cambodia, Canada, Czech Republic, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Guam, Guatemala, Iceland, India, Israel, Japan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Thailand, Turkey, United Arab Emirates..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0169-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 4, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.