Medline Sheath Removal Kit Recalled for Subpotent Iodine Concentration
Medline Industries is recalling 40 cases of Sheath Removal Kits because the iodine concentration is below the labeled claim.
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 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 hazard is a subpotent drug (lower than labeled concentration) rather than a toxic contamination or structural defect, and no injuries or illnesses are reported in the source text.
Plain-English summary
Medline Industries, Inc. is recalling 40 cases of Medline Sheath Removal Kits, sterile, single use only. The product was packaged in Mexico for Medline Industries, Inc., located in Northfield, IL. The recall is due to the titratable iodine contained in the Povidone-Iodine prep pads being below the label claim of 0.85%.
The affected product is identified by Pack Number DYNDA1356 and Lot 17DB2820. Distribution was nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
Consumers and healthcare facilities should stop using the recalled product and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- Medline Sheath Removal Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60063
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Antiseptic Prep Pads
- 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: DYNDA1356
- Lots: 17DB2820
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
- ModeratePovidone-iodine antiseptic solution recalled after testing subpotent in one lot
FDA (Drugs) · 2025-10-01
- SeverePurdue Pharma Recalls Betadine Swabsticks Due to Subpotent Drug Hazard
FDA (Drugs) · 2017-11-15
- ModerateMedline Recalls Mislabelled Vitamin A&D Ointment Packets
FDA (Drugs) · 2017-09-20
- HighAlcohol prep pads recalled from one lot as a subpotent drug
FDA (Drugs) · 2025-10-29
- HighMedline Recalls Surgical Kits Due to Potential Loss of Sterility
FDA (Devices) · 2020-05-27