Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 1, 2017
Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.
Pentax of America Inc recalled Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are inte… - a moderate-severity action.
Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are inte… was recalled by Pentax of America Inc in February 1, 2017. Reason: Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes M…. Check the official notice for the remedy. Verify recall #Z-1075-2017 with the FDA Devices before acting.
The recall
Pentax of America Inc issued this moderate-severity FDA Devices recall-Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes M….
- Moderate
- severity level
- Class II
- classification
- February 1, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1075-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1075-2017) was formally reported on February 1, 2017, with the manufacturer initiating the action on December 12, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Pentax of America Inc is listed as the recalling firm, operating out of Montvale, NJ. Federal records list the affected scope as 2,056 (1,545 (US) and 511 (OUS)).
The documented reason for this recall is: Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108. Distribution data in the federal record shows the product reached: Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy…. 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
2,056 (1,545 (US) and 511 (OUS))
Related Recalls
6
3 from same agency
Product description
Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
Reason for recall
Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1075-2017 |
| Date reported | February 1, 2017 |
| Date initiated | December 12, 2016 |
| Recalling firm | Pentax of America Inc |
| Firm location | Montvale, NJ |
| Affected scope | 2,056 (1,545 (US) and 511 (OUS)) |
| Distribution | Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Leb… |
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-1075-2017) 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? ▼
Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.. Recalled by Pentax of America Inc. Units affected: 2,056 (1,545 (US) and 511 (OUS)).
Why was this product recalled? ▼
Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 1, 2017. Severity: Moderate. Recall number: Z-1075-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1075-2017) 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 February 1, 2017. 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.