Medline I&D Tray Kits Recalled for Subpotent Povidone-Iodine Concentration
Medline Industries is recalling I&D Tray Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.
The agency’s classification
FDA (Drugs): 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury or property damage reports, or structural defects, are Severe. While no injuries are explicitly reported, the subpotent nature of a sterile surgical prep product in a Class II recall aligns with the Severe tier for significant risk.
Plain-English summary
Medline Industries, Inc. is recalling 40 cases of Medline I&D Tray Kits, Sterile, Single use only. The product is packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL. The specific pack number is DYNDA1109 and the lot number is 178B0923.
The recall is being issued because the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. This is classified as a subpotent drug issue.
The affected products were distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. Healthcare providers and facilities should stop using these specific lots and contact Medline Industries for further instructions.
The recalled product
- Product
- Medline I&D Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Surgical Prep
- Affected units
- 40
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 (2)
- Pack Number: DYNDA1109
- Lots: 178B0923
Distribution
Part of a larger recall action
This product is one of 68 recalled by Medline Industries Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 68 products in this recall →Related recalls
Same manufacturer · Medline Industries Inc
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- ModerateBedside PICC CDS Convenience Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
Same hazard · subpotent drug
See all →- LowImprimisRx Recalls Subpotent Povidone Iodine and Proparacaine Ophthalmic Solution
FDA (Drugs) · 2026-09-16
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-09-02
Similar recalls
- ModerateMedline Recalls Subpotent Povidone-Iodine Scrub Solution Bottles
FDA (Drugs) · 2018-03-07
- CriticalMedline Medical Kits Recalled Due to Potential Lack of Sterility
FDA (Devices) · 2024-03-06
- SevereMedline Instrument Trays Recalled for Potential Sterility Defect
FDA (Devices) · 2024-03-06
- HighAlcohol prep pads recalled from one lot as a subpotent drug
FDA (Drugs) · 2025-10-29
- ModerateMedline Alcohol Prep Pads Recalled for Subpotent Isopropyl Alcohol
FDA (Drugs) · 2025-03-26
- ModeratePDI Povidone-Iodine Prep Pads Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2021-09-01