Lower risk Medical device recall · FDA · Published October 16, 2017

DeRoyal Sterile Custom Kits: Povidone Iodine Prep Pads Have Incorrect Expiration Dates

DeRoyal recalls sterile surgical kits containing Medline Aplicare Povidone Iodine Prep Pads with incorrect expiration dates. Affected kits include specific tray and pack models with listed lot numbers. Consumers should check their kit's reference numbers and lot numbers to determine if recalled.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0199-2018Medical device DeRoyal ›

Lower-risk recall

Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.

Take action

Contact the company

Recalling firmDeRoyal Industries Inc200 Debusk Ln · Powell, TN 37849-4703

✎ GovInfoNow plain-language explainer

DeRoyal is recalling sterile surgical kits that contain Medline Aplicare Povidone Iodine Prep Pads with incorrect expiration dates. This could lead to using expired products that may not be safe for medical procedures. Read more at govinfonow.com/recall/72834-deroyal-sterile-custom-kits-povidone-iodine-prep-pads-have-incorrect.

Source Summary by GovInfoNow · govinfonow.com/recall/72834-deroyal-sterile-custom-kits-povidone-iodine-prep-pads-have-incorrect · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0199-2018

Cite this page

“DeRoyal Sterile Custom Kits: Povidone Iodine Prep Pads Have Incorrect Expiration Dates.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72834-deroyal-sterile-custom-kits-povidone-iodine-prep-pads-have-incorrect. Based on FDA recall #Z-0199-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0199-2018%22&limit=1).

The FDA announced on 2017-10-16 that DeRoyal Industries Inc is recalling DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads due to incorrect expiration dates. The agency issued recall number Z-0199-2018 for the Class II voluntary recall.

How to tell if you have it

Brand: DeRoyal
Product: DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads
Incision and Drainage Tray, REF 47-763.04, Lot Numbers: 42728139, 42812373
Incision and Drainage Tray, REF 47-763.06, Lot Numbers: 43638080, 44508341
Incision and Drainage Tray, REF 47-763.07, Lot Number: 44877040
Cricothyreotomy Ambulance Kit, REF 89-6752.01, Lot Numbers: 43183812, 43959220, 44484561, 44514919
Incision and Drainage Tray, REF 89-6818.02, Lot Numbers: 42054787, 42691241, 43197966, 43979458
Plastic Pack, REF 89-7212.04, Lot Numbers: 41684621, 41957423, 42302605, 42623281, 42699622, 42982612, 43253681, 43504920, 43793400, 44094150, 44543787, 45017543
Plastic Pack, REF 89-7212.05, Lot Number: 45456132
Distribution: US Nationwide in GA, IN, FL, and PA
Units affected: 5946

The hazard

Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date. The FDA classified the recall as Class II.

Context

GovInfoNow's records show DeRoyal Industries Inc has 29 other recalls on record since 2017-06-07. Recent DeRoyal recalls include a 2026-08-20 Myocardial Probe Recall for incorrect needle size, a 2026-05-18 Covaderm Plus Dressing Recall for sterility risk, and a 2025-01-31 Suction Tubing Recall for inadequate suction. Other recent recalls of similar products include a 2026-01-07 Medline Convenience Kits Recall for contaminated sterile products, a 2026-03-16 Medline Centurion Kits Recall for non-sterile alcohol prep pads risk, and a 2026-06-12 Medline Convenience Kits Recall for sterile packaging breach.

How to tell if you have this one

Check the reference number (REF) and lot number on your DeRoyal Sterile Custom kit. Affected kits include specific models like Incision and Drainage Tray REF 47-763.04, REF 47-763.06, REF 47-763.07, and others with the listed lot numbers.

Brand
DeRoyal
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Reference Numbers
Look for the reference number (REF) and lot number on your DeRoyal Sterile Custom kit to determine if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 4 states.

FDA distribution: “US Nationwide distribution in the states of GA, IN, FL, and PA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Georgia, Indiana, Pennsylvania.

Recall timeline

FDA terminated this recall 2.8 years after the firm started it.

Oct 16, 2017Firm started the recall
Dec 6, 2017FDA classified it Class II
Dec 13, 2017Published in FDA’s Enforcement Report
Aug 21, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/72834-deroyal-sterile-custom-kits-povidone-iodine-prep-pads-have-incorrect">DeRoyal Sterile Custom Kits: Povidone Iodine Prep Pads Have Incorrect Expiration Dates (GovInfoNow)</a>

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-0199-2018 (October 16, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0199-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 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.