DeRoyal Ultra/Mammo Tray Swab Recall: Uncertain Test Validation Risk
DeRoyal recalls Ultra/Mammo Tray swabs due to uncertain test validation during manufacturing. Affected swabs have specific lot numbers and expiration dates. Consumers should check their product details.
Recall notice
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Contact the company
What happened, in plain English
DeRoyal is recalling swabs for surgical skin prep due to uncertain test validation during manufacturing. This means the swabs' effectiveness and safety aren't fully confirmed, which could affect medical procedures. Read more at govinfonow.com/recall/60992-deroyal-ultra-mammo-tray-swab-recall-uncertain-test-validation-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/60992-deroyal-ultra-mammo-tray-swab-recall-uncertain-test-validation-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0879-2022
Cite this page
“DeRoyal Ultra/Mammo Tray Swab Recall: Uncertain Test Validation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60992-deroyal-ultra-mammo-tray-swab-recall-uncertain-test-validation-risk. Based on FDA recall #Z-0879-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0879-2022%22&limit=1).
Why it’s dangerous
The swabs contain chlorhexidine gluconate and isopropyl alcohol. The recall states that test methods used to validate the swabs' quality were uncertain, meaning their effectiveness and safety aren't fully confirmed. This could lead to inadequate skin preparation during medical procedures.
Who’s affected
Healthcare professionals using the DeRoyal Ultra/Mammo Tray for patient skin preparation before surgery or injections are most at risk. Patients using these swabs for medical procedures may also be affected.
How to tell if you have this one
Check for the DeRoyal Ultra/Mammo Tray with the specific lot numbers listed: 53334442 (exp 05/01/2021), 53815781 (exp 06/01/2022), 54685720 (exp 06/01/2022), 55247529 (exp 03/01/2023), and 55967067 (exp 04/01/2023).
- Brand
DeRoyal- Category
Medical device
All 3 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 distribution to Florida, New Jersey, and Tennessee
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0878-2022 | DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.; SKU/Part Number 47-670.06; UDI 00749756562942 Lot Numbers (Expiration Date): Lot 52585717 (exp 07/01/2021), Lot 52818525 (exp 07/01/2021), Lot 54354867 (exp 04/01/2022), Lot 55502331 (exp 04/01/2022) | 400 kits |
| Z-0879-2022 | DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.; SKU/Part Number 89-4990.06; UDI 00749756623599 Lot Numbers (Expiration Date): Lot 53334442 (exp 05/01/2021), Lot 53815781 (exp 06/01/2022), Lot 54685720 (exp 06/01/2022), Lot 55247529 (exp 03/01/2023), Lot 55967067 (exp 04/01/2023) | 780 kits |
| Z-0880-2022 | DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.; SKU/Part Number 89-5300.07; UDI 00749756632317 Lot Numbers (Expiration Date): Lot 53059743 (exp 06/01/2022), Lot 53632941 (exp 06/01/2022), Lot 53666113 (exp 06/01/2022), Lot 54205909 (exp 06/01/2022), Lot 54279422 (exp 06/01/2022), Lot 54327332 (exp 06/01/2022), Lot 54473313 (exp 06/01/2022), Lot 55573404 (exp 06/01/2022) | 1360 kits |
What to do — step by step
Check Product Details
Identify the lot number and expiration date on your DeRoyal Ultra/Mammo Tray swabs to confirm if they are affected.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “US distribution to Florida, New Jersey, and Tennessee” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, New Jersey, Tennessee.
Recall timeline
FDA terminated this recall 6 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-0879-2022 (March 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0879-2022 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.