Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0199-2018·Announced 2017-12-13

DeRoyal Surgical Kits Recalled for Incorrect Expiration Date on Prep Pads

DeRoyal is recalling sterile custom surgical kits containing Medline Aplicare Povidone Iodine Prep Pads due to incorrect expiration dates.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the specific hazard is a minor labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.

Plain-English summary

DeRoyal Industries Inc is recalling 5,946 units of sterile custom surgical kits. These kits contain Medline Aplicare Povidone Iodine Prep Pads that were subsequently recalled by Medline Industries for incorrect expiration dates. The affected products include various Incision and Drainage Trays, a Cricothyreotomy Ambulance Kit, and Plastic Packs.

The recall covers specific reference numbers and lot numbers distributed nationwide in Georgia, Indiana, Florida, and Pennsylvania. The primary issue is a labeling error regarding the expiration date of the povidone iodine prep pads included in the kits.

Healthcare facilities and consumers should stop using these specific kits and contact DeRoyal Industries Inc for instructions on how to return or dispose of the affected products.

The recalled product

Product: DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tray, REF 47-763.07 d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 e)…
Manufacturer: DeRoyal Industries Inc
Category: Medical Device — Surgical Kits
Hazard: mis-labeling
Affected units: 5,946

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 (20)

a) REF 47-763.04
Lot Numbers:42728139
42812373 b) REF 47-763.06
Lot Numbers:43638080
44508341 c) REF 47-763.07
Lot Number:44877040 d) REF 89-6752.01
Lot Numbers:43183812
43959220
44484561
44514919 e) REF 89-6818.02
Lot Numbers:42054787
42691241
43197966
43979458 f) REF 89-7212.04
Lot Numbers:41684621
41957423
42302605
42623281
42699622
42982612

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Same manufacturer · DeRoyal Industries Inc

See all →

Moderate
DeRoyal Myocardial Probe Recall Due to Incorrect Needle Length
FDA (Devices) · 2026-09-30
Moderate
Vascular Access Dressing Recalled Due to Lack of Sterility Assurance
FDA (Devices) · 2026-06-10
High
DeRoyal Suction Connector Tubing Recalled for Assembly and Function Issues
FDA (Devices) · 2025-03-12
High
DeRoyal AMG Suction Connector Tubing connection may fail to seal
FDA (Devices) · 2025-02-26
High
DeRoyal Children's Orthopedic Tracepack Smoke Evacuation Pencil Malfunction Recall
FDA (Devices) · 2024-11-13

Same hazard · mis labeling