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Lower risk Medical device recall · FDA · Published November 2, 2021

RoyalSilk Surgical Gowns X-large: Sterility Risk in Packaging

Cardinal Health recalls RoyalSilk Non-Reinforced Surgical Gowns X-large (SKU 9548) due to potential open packaging seals compromising sterility. Affected lot numbers and UDI provided for identification.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0376-2022Medical deviceCardinal Health ›
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Recalling firmCardinal Health1270 Waukegan Rd Bldg C · Waukegan, IL 60085-6722
✎ GovInfoNow plain-language explainer

Cardinal Health is recalling RoyalSilk Non-Reinforced Surgical Gowns X-large (SKU 9548) because the packaging seals might not stay closed, risking contamination during surgery. This could lead to infections if the gowns are used without proper sterility. Read more at govinfonow.com/recall/61598-royalsilk-surgical-gowns-x-large-sterility-risk-in-packaging.

Source Summary by GovInfoNow · govinfonow.com/recall/61598-royalsilk-surgical-gowns-x-large-sterility-risk-in-packaging · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0376-2022

Cite this page

“RoyalSilk Surgical Gowns X-large: Sterility Risk in Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61598-royalsilk-surgical-gowns-x-large-sterility-risk-in-packaging. Based on FDA recall #Z-0376-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0376-2022%22&limit=1).

Cardinal Health recalled RoyalSilk Non-Reinforced Surgical Gowns in size X-large due to potential open packaging seals that could compromise sterility, the FDA said on Nov. 2, 2021.

How to tell if you have it

  • Brand: Cardinal Health
  • Product: RoyalSilk Non-Reinforced Surgical Gowns
  • Size: X-large
  • SKU: 9548
  • Lot Numbers: 20MMQ004, 20MMQ005, 20MMQ006, 21AMQ005, 21AMQ006, 21BMQ006, 21CMQ004, 21CMQ005, 21CMQ006, 21CMQ007, 21FMQ003, 21FMQ004, 21HMQ002, 21HMQ006
  • Units affected: 270,839

The hazard

The recall addresses the potential for open packaging seals to compromise the sterility of the surgical gowns.

Context

GovInfoNow's records show Cardinal Health has issued four other recalls since Oct. 2, 2013. Other recent recalls include a Nov. 1, 2022 blockage risk in Dover Closed Urethral Trays and an Aug. 4, 2021 air reintroduction risk in Monoject Syringes. Similar product recalls include Alcon's Nov. 24, 2025 sterility risk from incomplete seals and Medline's Jan. 7, 2026 surgical gown sterility risk.

How to tell if you have this one

Check for the SKU 9548 on the gown label. Look for lot numbers: 20MMQ004 through 21HMQ006. The unique device identifier (UDI) 50192253006177 (cs) or 10192253006179 (ea) is also associated with these items.

  • Brand
    Cardinal Health
  • Category
    Medical device
FDA recall event · 11 products

All 11 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
Recall numberProduct, codes & lotsQuantity
Z-0368-2022SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474; Lot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50192253018927 (Cs) 10192253018929 (Ea)224,312 units
Z-0369-2022SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011; Lot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50885380172500 (cs) 10885380172502 (ea)169,262 units
Z-0370-2022SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041; Lot Numbers: 20MJQ001 20MJQ002 21AJQ001 21AJQ002 21AJQ003 21AJQ004 21AJQ005 21AJQ006 21BJQ001 21BJQ002 21CJQ001 21DJQ001 21DJQ002 21DJQ003 21EJQ001 21EJQ002 21EJQ003 21EJQ004 21FJQ001 21FJQ002 21FJQ003 21GJQ001 21GJQ002 21HJQ001 21HJQ002 21HJQ003 21HJQ004 21HJQ005 21HJQ006 21JJQ001 21JJQ002 21JJQ003 UDI: 50885380172494 (cs) 10885380172496 (ea)231,219 units
Z-0371-2022SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL; Lot Numbers: 20MBQ001 21ABQ001 21ABQ002 21BBQ002 21BBQ003 21BBQ004 21BBQ005 21CBQ002 21CBQ003 21DBQ003 21DBQ004 21DBQ005 21EBQ003 21EBQ004 21EBQ005 21FBQ002 21FBQ003 21FBQ004 21FBQ005 21HBQ001 21HBQ002 21JBQ002 UDI: 50192253018996 (cs) 10192253018998 (ea)363,480 units
Z-0372-2022Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010; Lot Numbers: 20MDQ014 21ADQ007 21CDQ004 21CDQ005 21DDQ001 21DDQ002 21EDQ001 21FDQ001 21GDQ001 21HDQ001 21JDQ003. UDI: 50192253018972 (cs) 10192253018974 (ea)17,174 units
Z-0373-2022Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040; Lot Numbers: 20MEQ001 21AEQ00 21BEQ001 21BEQ002 21BEQ003 21CEQ001 21DEQ001 21DEQ002 21EEQ001 21EEQ002 21FEQ001 21FEQ002 21GEQ001 21HEQ001 21HEQ002 21JEQ001 21JEQ002. UDI: 50192253018989 (cs) 10192253018981 (ea)146,939 units
Z-0374-2022Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070; Lot Numbers: 21CKQ001 21CKQ002 21HKQ001. UDI: 50192253005941 (cs) 10192253005943 (ea)29,893 units
Z-0375-2022RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518; Lot Numbers: 20MMQ001 20MMQ002 20MMQ003 21AMQ001 21AMQ002 21AMQ003 21AMQ004 21BMQ001 21BMQ002 21CMQ001 21CMQ002 21CMQ003 21EMQ001 21EMQ002 21FMQ001 21FMQ002 21HMQ001. UDI: 50192253006160 (cs) 10192253006162 (ea)364,481 units
Z-0376-2022RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548; Lot Numbers: 20MMQ004 20MMQ005 20MMQ006 21AMQ005 21AMQ006 21BMQ006 21CMQ004 21CMQ005 21CMQ006 21CMQ007 21FMQ003 21FMQ004 21HMQ002 21HMQ006. UDI: 50192253006177 (cs) 10192253006179 (ea)270,839 units
Z-0377-2022RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578; Lot Numbers: 20MLQ001 21BLQ001 21CLQ001 21DLQ001 21DLQ002 21ELQ001 21ELQ002 21ELQ003 21GLQ001 21HLQ001. UDI: 50192253006184 (cs) 10192253006186 (ea)9,990 units
Z-0378-2022RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998; Lot Numbers: 20MMQ007 21BMQ007 21CMQ008 21DMQ001 21EMQ003 21FMQ007. UDI: 50192253006191 (cs) 10192253006193 (ea)8,950 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Labels

    Look for SKU 9548, lot numbers listed in the recall notice, and the UDI codes 50192253006177 (cs) or 10192253006179 (ea).

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 50 days after the firm started it.

1. Firm started the recall: Nov 2, 202112. FDA classified it Class II: Dec 10, 202123. Published in FDA’s Enforcement Report: Dec 22, 202132021
  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-0376-2022 (November 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0376-2022 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