Z-1283-2023Class II

DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B

Name: Z-1283-2023 DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Creator: DeRoyal Industries Inc
Published: 2023-02-09
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2023-02-09 / Open, Classified / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B on 2023-02-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1283-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-09
Posted: 2023-03-23
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Product code: KDQ Bottle, Collection, Vacuum
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected] or by phone 865-362-4203 or email us at [email protected]. If you have questions regarding this recall please contact us at 865-362-6465 or email us at [email protected].
Quantity in commerce: 27,200 devices
Distribution: US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.
Product codes and lots: GTIN 50749756377046, Lot 58447585 exp. 12/22/2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1283-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1283-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-23

Product code KDQ

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)