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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model #'s 9106 and 9108
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Pentax of America Inc
- Reason for Recall:
- Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Model #'s 9106 and 9108
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1075-2017
Related Recalls
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Pentax of America
During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.