Recall archive / FDA device enforcement
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B — FDA record Z-1283-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 9, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
- 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.
- Classification
- Class II
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 27,200 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1283-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 50749756377046, Lot 58447585 exp. 12/22/2027 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 29, 2023
- Recall initiation date
- Feb 9, 2023
- Center classification date
- Mar 23, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.