CLASS II Device recall · Reported 26 Jul 2017 · FDA Enforcement Report
9400 Laryngeal Strobe recalled by Pentax of America
Pentax of America is recalling 9400 Laryngeal Strobe, distributed nationwide in the US. The recall was initiated on 13 Apr 2017 and the FDA has classified it as Class II.
Check your package
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-2744-2017
- FDA event ID
- 77137
- Recalling firm
- Pentax of America, Montvale, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2017
- FDA classified
- 18 Jul 2017
- Reported
- 26 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 Apr 2017 | Recall initiated by company | |
| 18 Jul 2017 | Classified by FDA | +96 days |
| 26 Jul 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Product as listed by the FDA
9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
Where it was distributed
Worldwide Distribution - US Nationwide
Questions about this recall
Why was it recalled?
Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Which lots are affected?
35865-10 35866-22 37879-10 38332-20 38935-159 40356-06 41305-16 41687-20 80002-01 80002-17 80279-12
Where was it sold?
Worldwide Distribution - US Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 77137| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 9200C and 9200D Laryngeal Strobe recalled by Pentax of America | Pentax of America | Other | Nationwide | |
| CLASS II | 7245C, 7245C/E, 7245D Computer Digital Video System recalled | Pentax of America | Other | Nationwide | |
| CLASS II | 9310HD Digital Video Capture Modules recalled by Pentax of America | Pentax of America | Other | Nationwide |
More recalls from Pentax of America
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pentax Medical Video Processor recalled by Pentax of America | Pentax of America | Other | 20 states |
| Device | CLASS II | Pentax Medical Video Colonoscope- Intended to provide recalled | Pentax of America | Other | Nationwide |
| Device | CLASS II | Pentax Medical Video Upper GI Scope-Intended to provide recalled | Pentax of America | Other | Nationwide |
| Device | CLASS II | Pentax Medical Video Processor- Intended to be used recalled | Pentax of America | Other | Nationwide |
| Device | CLASS II | Colonoscope Family # 1-Pentax Video Colonoscopes recalled | Pentax of America | Other | Nationwide |
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