DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to 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 the hazard involves unknown contamination in sterile medical devices, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
DeRoyal Industries, Inc. is recalling DeRoyal Sterile Custom Kits containing Cardinal Health gowns. The recall involves 2,100 units of the product, specifically the Shoulder Pack 89-4751.08. The affected lots include catalog number 9541NA with lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, and 4418GSJ, as well as Shoulder Pack 89-4751.08 with lot number 49505405 and an expiration date of 11/01/2021.
The recall was initiated because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. These defects compromise the sterility of the medical devices.
The affected products were distributed in Rhode Island and New Jersey, specifically to the V.A Med Ctr East Orange. Consumers and healthcare facilities should stop using the affected products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
- Manufacturer
- Deroyal Industries, Inc. Lafollette
- Category
- Medical Device — Surgical Gowns
- Affected units
- 2,100
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 (6)
- Catalog number 9541NA
- lot numbers 2708DJ1
- 3008DJ1
- 3008DSJ1 and 4418GSJ
- Shoulder Pack 89-4751.08
- Lot number: 49505405 exp. 11/01/2021
Distribution
Part of a larger recall action
This product is one of 10 recalled by Deroyal Industries, Inc. Lafollette 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 10 products in this recall →Related recalls
Same manufacturer · Deroyal Industries, Inc. Lafollette
See all →- SevereDeRoyal Procedure Packs with NORMOFLO Warming Sets Recalled for Aluminum Leaching
FDA (Devices) · 2021-10-06
- ModerateTeleflex Pilling Aortic Punch Recalled for Potential Sterile Packaging Compromise
FDA (Devices) · 2020-03-25
- HighDeRoyal Sterile Custom Kits Recalled Due to Unknown Contamination Levels
FDA (Devices) · 2020-03-11
- HighDeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination
FDA (Devices) · 2020-03-11
- HighDeRoyal Sterile Custom Kits Recalled for Unknown Contamination
FDA (Devices) · 2020-03-11
Same hazard · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAvid Medical Recalls Davinci Trucustom Bundles 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
- ModerateAVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighCardinal Health Recalls Surgical Gowns Due to Unknown Contamination
FDA (Devices) · 2020-02-12
- SevereCardinal Health Recalls ROYALSILK Gowns Due to Unknown Contamination
FDA (Devices) · 2020-02-12
- SevereCardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels
FDA (Devices) · 2020-02-12
- HighCardinal Health Surgical Gowns Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-12-22
- HighCustom Medical Procedure Packs Recalled for Compromised Package Seals
FDA (Devices) · 2023-07-12
- HighCardinal Health Recalls AAMI 3 Surgical Gowns Due to Contamination
FDA (Devices) · 2020-02-12