Cardinal Health Recalls RoyalSilk Gowns Due to Unknown Contamination
Cardinal Health is recalling RoyalSilk XLARGE gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves unknown contamination (bioburden, microbiological flora, particulate) in a medical device. Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported' or high-risk pathogens without reported illness, warranting a score of 3.
Plain-English summary
Cardinal Health is recalling approximately 7.7 million units of ROYALSILK XLARGE gowns (Item Code 9548). The recall covers gowns manufactured in 2018 and 2019 that were distributed worldwide, including the United States, Puerto Rico, Guam, and various international markets.
The gowns are being recalled because they contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The source text does not specify the exact nature of the contaminants or the specific health risks associated with them.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ROYALSILK XLARGE, Gown. Item Code 9548
- Manufacturer
- Cardinal Health
- Category
- Medical Device — Surgical Gowns
- Affected units
- 7,659,634
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 244 or greater is affected OR " " If made in 2019
- any value is affected
Distribution
Part of a larger recall action
This product is one of 39 recalled by Cardinal Health under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 39 products in this recall →Related recalls
Same manufacturer · Cardinal Health
See all →- HighDover Closed Urethral Tray Recalled for Potential Drainage Blockage Risk
FDA (Devices) · 2022-12-14
- HighDover Urethral Catheter Drainage System Recall for Potential Port Blockage
FDA (Devices) · 2022-12-14
- HighDover Urinary Catheter Drainage Tray Recall Due to Blockage Risk
FDA (Devices) · 2022-12-14
- HighDover Closed Urethral Tray Recalled Due to Drainage Port Blockage Risk
FDA (Devices) · 2022-12-14
- HighDover urinary catheter drainage bag occlusion defect nationwide recall
FDA (Devices) · 2022-12-14
Same hazard · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls 15 Laparoscopic Prostatectomy Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighCardinal Health RoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-12-22
- HighRoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-12-22
- HighCardinal Health Recalls RoyalSilk Surgical Gowns for Compromised Packaging Seals
FDA (Devices) · 2021-12-22
- HighCardinal Health RoyalSilk Surgical Gowns Recalled for Sterility Compromise
FDA (Devices) · 2021-12-22
- HighDeRoyal Sterile Custom Kits Recalled for Unknown Contamination
FDA (Devices) · 2020-03-11
- HighCardinal Health Surgical Gowns X-Large Recalled for Packaging Seal Defect
FDA (Devices) · 2021-12-22