Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels
Cardinal Health is recalling AAMI 3 Royalsilk Surgical 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 involves a medical device with unknown contamination levels (bioburden, flora, particulate) which poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health is recalling AAMI 3 Royalsilk Surgical Gowns (Item Code 90380NC) in size XL. The recall affects 7,659,634 total units. The gowns are distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam), the United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, the Dominican Republic, Israel, Mexico, Oman, Panama, the Philippines, and Saudi Arabia.
The recall is being conducted because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The agency has classified this as a Class II recall. Affected lot numbers follow specific formats for single-sterile and bulk non-sterile products, generally involving facility code 'J' and production dates from 2018 or 2019.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
- 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 Recalls RoyalSilk Surgical Gowns for Compromised Packaging Seals
FDA (Devices) · 2021-12-22
- 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 Presource Procedure Packs Due to Sterility Concerns
FDA (Devices) · 2020-02-26
- HighCardinal Health RoyalSilk Surgical Gowns Recalled for Sterility Compromise
FDA (Devices) · 2021-12-22
- HighCardinal Health Recalls Presource Procedure Packs with Potential Sterility Issues
FDA (Devices) · 2020-02-26