FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
- Recall number
- Z-1283-2023
- Recalling firm
- DeRoyal Industries Inc
- Product
- DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
- Status
- Open, Classified
- Initiated
- 2023-02-09
- Posted
- 2023-03-23
- Terminated
- not on file
- Reason
- The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum.
- Root cause
- Process control
- Action
- The firm issued an URGENT DEROYAL RECALL NOTICE its consignees by email and letter beginning on 02/09/2023. The notice explained the problem and risk, and requested the following actions be taken: Identify and quarantine any affected product found in inventory. If the product has been further distributed, please notify then of this recall. Firm is seeking product return. Questions about receiving credit for return merchandise, contact Jennifer Marsh at jmarsh@deroyal.com or by phone 865-362-4203 or email us at recalls@deroyal.com. If you have questions regarding this recall please contact us at 865-362-6465 or email us at recalls@deroyal.com.
- Quantity
- 27,200 devices
- Distribution
- US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.
- Lot, serial or model codes
- GTIN 50749756377046, Lot 58447585 exp. 12/22/2027
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDQ
- Firm FEI
- 1043214
- Firm city
- Powell
- Firm state
- TN
- 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