DeRoyal Sterile Custom Kits with Cardinal Health Gowns Recalled for Unknown Bioburden
DeRoyal recalls sterile custom kits with Cardinal Health gowns due to unknown bioburden and contamination risks. Affected kits include ASC Thyroid Pack 89-6302.14 with specific lot numbers. Consumers should check their kit details and contact DeRoyal for guidance.
Recall notice
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Contact the company
What happened, in plain English
DeRoyal is recalling sterile custom kits that include Cardinal Health gowns because these gowns may contain unknown levels of bacteria and particles. This could pose a risk of infection or contamination during medical procedures. The recall affects specific kits sold with certain lot numbers and expiration dates. Read more at govinfonow.com/recall/65887-deroyal-sterile-custom-kits-with-cardinal-health-gowns-recalled-for.
Source Summary by GovInfoNow · govinfonow.com/recall/65887-deroyal-sterile-custom-kits-with-cardinal-health-gowns-recalled-for · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1416-2020
Cite this page
“DeRoyal Sterile Custom Kits with Cardinal Health Gowns Recalled for Unknown Bioburden.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65887-deroyal-sterile-custom-kits-with-cardinal-health-gowns-recalled-for. Based on FDA recall #Z-1416-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1416-2020%22&limit=1).
Why it’s dangerous
The gowns may contain unknown levels of bacteria, particles, and microbial growth. This could lead to infections or contamination if used in medical procedures where sterility is critical.
Who’s affected
Patients and healthcare providers using DeRoyal Sterile Custom Kits with Cardinal Health gowns are affected. Those with the specific ASC Thyroid Pack 89-6302.14 model and listed lot numbers are most at risk.
How to tell if you have this one
Check for the ASC Thyroid Pack 89-6302.14 model. Look for lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, 49310958, or 49675501. The kits may expire by September 1, 2023, or later.
- Brand
DeRoyal- Category
Medical device
All 10 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
Terminated- Distribution
US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1410-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;; Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Outpatient Major 89-3865.12, Lot numbers: 47061206 exp. 06/01/2022, 49505579 exp. 03/01/2023, 4955103 exp. 03/01/2023 | 2,100 units total |
| Z-1411-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17; Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Chronic Ear Pack 89-4393.17, Lot number: 49241024 exp. 07/01/2020; | 2100 units |
| Z-1412-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08; Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Shoulder Pack 89-4751.08, Lot number: 49505405 exp. 11/01/2021 | 2100 units |
| Z-1413-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16; Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; ASC General Pack 89-6015.16, Lot Numbers: 49215900 exp. 06/01/2023, 49266256 exp. 06/01/2023; | 2100 units |
| Z-1414-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15; Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Cystoscopy Pack 89-6071.15, Lot number: 49442168 exp 03/01/2021; | 2100 units |
| Z-1415-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13; Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; f. ASC Laparoscopy Pack 89-6138.13, Lot number: 49505093 exp.10/01/2023; | 2100 units |
| Z-1416-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14; Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; ASC Thyroid Pack 89-6302.14, Lot numbers: 49310958 exp. 09/01/2023, 49675501 exp. 09/01/203 | 2100 units |
| Z-1417-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08; Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Opthalmology CSTM PCK 89-6387.08, Lot number: 49512592 exp. 07/01/2022 | 2100 units |
| Z-1418-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06; Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Kwik Kit 89-6389.06, Lot number: 49624025 exp. 07/01/2023 | 2100 units |
| Z-1419-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13; Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; ASC Ocular Plastics Pack 89-6498.13, Lot numbers: 49227281 exp. 08/01/2023, 49520963 exp. 09/01/2023 | 2100 units |
What to do — step by step
Check Kit Details
Identify your kit model and lot numbers to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in New Jersey and Rhode Island.
FDA distribution: “US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New Jersey, Rhode Island.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-1416-2020 (February 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1416-2020 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.