Medline Catheter Care Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling lidded catheter care trays 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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant injury or property damage reports, or structural defects, though here it is a subpotent drug issue which still warrants the higher classification due to the potential for treatment failure.
Plain-English summary
Medline Industries, Inc. is recalling 1,000 cases of Medline TRAY, CATHETER CARE, LIDDED. The recall is due to a subpotent drug issue where the titratable iodine in the povidone-iodine prep pads is below the label claim of 0.85%.
The affected product was distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. The specific lots involved are 16KA2117, 16LA1083, 15GA1298, 16KA0905, and 16BA0141, with Pack Number DYND12110.
Consumers and healthcare facilities should check their inventory for these specific lot numbers and stop using the affected trays. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Medline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Antiseptic / Prep Pads
- Affected units
- 1,000
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 (7)
- Pack Number: DYND12110
- Lots: 16KA2117
- 16LA1083
- 15GA1298
- 16KA0905
- 16KA2117
- 16BA0141
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
- SevereMedline Instrument Trays Recalled for Potential Sterility Defect
FDA (Devices) · 2024-03-06
- ModerateMedline Recalls Subpotent Povidone-Iodine Scrub Solution Bottles
FDA (Drugs) · 2018-03-07
- SevereMedline Medical Kits and Trays Recalled for Potential Sterility Failure
FDA (Devices) · 2024-03-06
- HighMedline pre-connected urethral catheterization trays fail performance specifications
FDA (Devices) · 2026-06-24
- ModerateMedline Sodium Chloride Injection Recalled for Incorrect Overwrap Packaging
FDA (Devices) · 2018-09-05
- HighAlcohol prep pads recalled from one lot as a subpotent drug
FDA (Drugs) · 2025-10-29