Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration
Medline is recalling 1,100 cases of GHS Suture Removal Trays because the iodine concentration is below the label 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 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, which corresponds to a Severe rating under the rubric.
Plain-English summary
Medline Industries Inc. is recalling 1,100 cases of Medline GHS Suture Removal Trays, Sterile, Single Use Only. The recall was initiated because the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%.
The affected product is identified by Pack Number DYNDR1056 and Lot 17RB9450. The product was distributed 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 affected product and contact Medline Industries Inc. for further instructions or a refund.
The recalled product
- Product
- Medline GHS Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Hazard
- Affected units
- 1,100
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: DYNDR1056
- Lots: 17RB9450
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
- HighMedline Recalls Surgical Kits Due to Potential Loss of Sterility
FDA (Devices) · 2020-05-27
- ModerateMedline Recalls Sterile Piston Irrigation Syringe Trays Due to Packaging Defects
FDA (Devices) · 2019-09-04
- SevereMedline Instrument Trays Recalled for Potential Sterility Defect
FDA (Devices) · 2024-03-06
- CriticalMedline Surgical Kits Recalled for Potential Sterility Failure
FDA (Devices) · 2024-03-06
- ModerateMedline Alcohol Prep Pads Recalled for Subpotent Isopropyl Alcohol
FDA (Drugs) · 2025-03-26