CLASS II ONGOING Device recall · Reported 29 Mar 2023 · FDA Enforcement Report
DeRoyal SafeLiner Suction Canister, 1000cc recalled
DeRoyal Industries is recalling DeRoyal SafeLiner Suction Canister, 1000cc, distributed nationwide in the US. The recall was initiated on 9 Feb 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1283-2023
- FDA event ID
- 91760
- Recalling firm
- DeRoyal Industries, Powell, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Feb 2023
- FDA classified
- 23 Mar 2023
- Reported
- 29 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 9 Feb 2023 | Recall initiated by company | |
| 23 Mar 2023 | Classified by FDA | +42 days |
| 29 Mar 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Where it was distributed
US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.
Nationwide ArkansasArizonaCaliforniaIllinoisIndianaMissouriNorth CarolinaOhioPennsylvaniaTexasVirginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
GTIN 50749756377046, Lot 58447585 exp. 12/22/2027
Where was it sold?
US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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