CLASS II ONGOING Device recall · Reported 22 Dec 2021 · FDA Enforcement Report

RoyalSilk Non-Reinforced Surgical Gowns X-large recalled

Cardinal Health is recalling RoyalSilk Non-Reinforced Surgical Gowns X-large, distributed nationwide in the US. The recall was initiated on 2 Nov 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 20MMQ004 20MMQ005 20MMQ006 21AMQ005 21AMQ006 21BMQ006 21CMQ004 21CMQ005 21CMQ006 21CMQ007 21FMQ003 21FMQ004 21HMQ002 21HMQ006. UDI: 50192253006177 (cs) 10192253006179 (ea)

Quantity recalled270,839 units

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-0376-2022
FDA event ID: 89015
Recalling firm: Cardinal Health, Waukegan, IL
Classification: Class II
Status: Ongoing
Recall initiated: 2 Nov 2021
FDA classified: 10 Dec 2021
Reported: 22 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

2 Nov 2021	Recall initiated by company
10 Dec 2021	Classified by FDA	+38 days
22 Dec 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for open packaging seals compromising the sterility of the surgical gowns

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

Nationwide

Questions about this recall

Why was it recalled?

Potential for open packaging seals compromising the sterility of the surgical gowns

Which lots are affected?

Lot Numbers: 20MMQ004 20MMQ005 20MMQ006 21AMQ005 21AMQ006 21BMQ006 21CMQ004 21CMQ005 21CMQ006 21CMQ007 21FMQ003 21FMQ004 21HMQ002 21HMQ006. UDI: 50192253006177 (cs) 10192253006179 (ea)

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

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.

Other products in this recall event

10 other products · FDA event 89015

Reported	Class	Recall	Company	Reason	Where
22 Dec 2021	CLASS II	RoyalSilk Non-Reinforced Surgical Gowns Large recalled	Cardinal Health	Sterility	Nationwide
22 Dec 2021	CLASS II	SmartSleeve Poly-Reinforced Breathable Sleeve Surgical recalled	Cardinal Health	Sterility	Nationwide
22 Dec 2021	CLASS II	SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large recalled	Cardinal Health	Sterility	Nationwide
22 Dec 2021	CLASS II	Poly-Reinforced Surgical Gowns Large recalled by Cardinal Health	Cardinal Health	Sterility	Nationwide
22 Dec 2021	CLASS II	SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large recalled	Cardinal Health	Sterility	Nationwide
22 Dec 2021	CLASS II	RoyalSilk Non-Reinforced Surgical Gowns XX-large recalled	Cardinal Health	Sterility	Nationwide
22 Dec 2021	CLASS II	Poly-Reinforced Surgical Gowns XX-large recalled by Cardinal Health	Cardinal Health	Sterility	Nationwide
22 Dec 2021	CLASS II	SmartGown Breathable Surgical Gowns recalled by Cardinal Health	Cardinal Health	Sterility	Nationwide
22 Dec 2021	CLASS II	Poly-Reinforced Surgical Gowns X-large recalled by Cardinal Health	Cardinal Health	Sterility	Nationwide
22 Dec 2021	CLASS II	RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long recalled	Cardinal Health	Sterility	Nationwide

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All 315

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13 Aug 2025Drug	CLASS II	Recombinate, [Antihemophilic Factor (Recombinant)] vials recalled	Cardinal Health	Manufacturing (CGMP) Deviations	Nationwide
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All 3,809

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9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
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