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Lower risk Medical device recall · FDA · Published February 9, 2023

DeRoyal SafeLiner Suction Canister Recall: Lid Shrinkage Prevents Vacuum Seal

DeRoyal recalls 1000cc SafeLiner Suction Canisters with lid shrinkage that prevents vacuum seal. Affected units have REF PHESL-1000B and GTIN 50749756377046.

🇺🇸 FDA recall #Z-1283-2023Medical deviceDeRoyal ›
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Recalling firmDeRoyal Industries Inc200 Debusk Ln · Powell, TN 37849-4703
✎ GovInfoNow plain-language explainer

DeRoyal is recalling its SafeLiner Suction Canisters (1000cc, REF PHESL-1000B) because the lid shrinks and fails to seal properly, preventing vacuum creation. This means the canister won't function as intended for suction purposes. Read more at govinfonow.com/recall/58918-deroyal-safeliner-suction-canister-recall-lid-shrinkage-prevents-vacuum-seal.

Source Summary by GovInfoNow · govinfonow.com/recall/58918-deroyal-safeliner-suction-canister-recall-lid-shrinkage-prevents-vacuum-seal · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1283-2023

Cite this page

“DeRoyal SafeLiner Suction Canister Recall: Lid Shrinkage Prevents Vacuum Seal.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58918-deroyal-safeliner-suction-canister-recall-lid-shrinkage-prevents-vacuum-seal. Based on FDA recall #Z-1283-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1283-2023%22&limit=1).

The FDA announced on Feb. 9, 2023, that DeRoyal Industries Inc is recalling the DeRoyal SafeLiner Suction Canister due to lid shrinkage that prevents a proper seal. The agency issued recall number Z-1283-2023 for the Class II device.

How to tell if you have it

  • DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
  • UPC 50749756377046
  • Lot 58447585

The hazard

The canister lid shrinks, causing it to fail to contact the outer shell and create a vacuum seal. This defect means the device does not create or hold vacuum as intended.

Context

GovInfoNow's records show DeRoyal Industries Inc has 29 other recalls on record since June 7, 2017. Other recent recalls include the Myocardial Probe Recall (Aug. 20, 2026) and the Covaderm Plus Dressing Recall (May 18, 2026).

How to tell if you have this one

Check for the model number REF PHESL-1000B on the canister. The product also has GTIN 50749756377046 and was manufactured with Lot 58447585, expiring December 22, 2027.

  • Brand
    DeRoyal
  • Product
    DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Canister Model

    Look for the model number REF PHESL-1000B on the canister to confirm it is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 11 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Illinois, Indiana, Missouri, North Carolina, Ohio, Pennsylvania, Texas, Virginia.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Feb 9, 202312. FDA classified it Class II: Mar 23, 202323. Published in FDA’s Enforcement Report: Mar 29, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1283-2023 (February 9, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1283-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA