Harry J Bosworth Company Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; 12 trays per bag; catalog 0921885, Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; 12 trays per bag; catalog 0921885,
Brand
Harry J Bosworth Company
Lot Codes / Batch Numbers
catalog number 0921885, UPC +D68109218850G, product with date stamps of 4/6/2004, 5/4/2004, 6/16/2004, 7/22/2004, 7/23/2004 and 8/16/2004
Products Sold
catalog number 0921885, UPC +D68109218850G, product with date stamps of 4/6/2004, 5/4/2004, 6/16/2004, 7/22/2004, 7/23/2004 and 8/16/2004
Harry J Bosworth Company is recalling Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impressi due to The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth.
Recommended Action
Per FDA guidance
Bosworth initiated a recall of the trays by undated letter on 10/13/04 sent to all of their customers. The letters informed the accounts that the Tray Away #3 did not meet their standards, and requested the accounts to return all of the Tray Away #3 trays in stock for replacement. Follow-up letters dated 12/26/04 were sent to the consignees, requesting a response to the notification, indicating the amount of product being returned to Bosworth.
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