Premier Dental Products Co Laryngectomy Tubes, Jackson Original Stainless Steel, item number 1037214 size 4, item number 1037215 size 5, item number 1037216 size 6, item number 1037217 size 7, item number 1037218 size 8, item number 1037219 size 9, and item number 1037220 size 10. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Laryngectomy Tubes, Jackson Original Stainless Steel, item number 1037214 size 4, item number 1037215 size 5, item number 1037216 size 6, item number 1037217 size 7, item number 1037218 size 8, item number 1037219 size 9, and item number 1037220 size 10.
Brand
Premier Dental Products Co
Lot Codes / Batch Numbers
all lots ending with S or T
Products Sold
all lots ending with S or T
Premier Dental Products Co is recalling Laryngectomy Tubes, Jackson Original Stainless Steel, item number 1037214 size 4, item number 103721 due to foreign objects (polishing stones) in the tubes. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
foreign objects (polishing stones) in the tubes
Recommended Action
Per FDA guidance
The recalling firm issued a recall letter dated 8/5/04 to their distributors. The letter informs the accounts of the problem and the need to return any affected product. The recalling firm issued a second letter dated 8/11/04 to the distributors with instructions to conduct a sub-recall.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026