Z-0420-05

Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray...

Name: Z-0420-05 Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray...
Creator: Harry J Bosworth Company
Published: 2004-10-13
License: https://open.fda.gov/license/

Harry J. Bosworth Co. / initiated 2004-10-13 / Terminated / root cause: packaging

FDA source

Harry J Bosworth Company began a recall of Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray; The Bosworth Company, 7227 North Hamlin Avenue... on 2004-10-13. The reason FDA records is "The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0420-05
Status: Terminated
Initiated: 2004-10-13
Posted: 2005-01-25
Terminated: 2006-04-24
Recalling firm: Harry J. Bosworth Co.
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,
Product code: EHY Tray, Impression, Preformed
Reason for recall: The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth.
Root cause tag: packaging
FDA root cause: Other
Action: 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.
Quantity in commerce: 13,904 trays
Distribution: Nationwide and internationally to Canada, Australia, Hong Kong, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Taiwan, Thailand, Vietnam, Bahrain, Iran, Israel, Jordan, Lebanon, Oman, Qatar, Saudi Arabia, Syria, Turkey, United Arab Emirates, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom
Product codes and lots: 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

Product code EHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)