FDA Medical Device Recalls (openFDA)
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 number
- Z-0420-05
- Recalling firm
- Harry J Bosworth Company
- 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,
- Status
- Terminated
- Initiated
- 2004-10-13
- Posted
- 2005-01-25
- Terminated
- 2006-04-24
- Reason
- The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth.
- 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
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EHY
- Firm FEI
- 1410638
- Firm city
- Skokie
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28