Medline Medicine Cups Recalled for Incorrect Volume Markings
Medline Industries is recalling 1-ounce medicine cups because the 10 mL increment is incorrectly printed as 5 mL, creating a risk of medication dosing errors.
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, and the hazard involves a labeling error that could result in medication dosing errors, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Medline Industries Inc is recalling 1-ounce Medicine Cups used to measure liquid medication. The recall involves 903 cases and 4,090 sleeves, totaling 8,605,000 units, distributed across the Continental U.S. The affected products are identified by Lot Numbers 122211502 through 122212515.
The recall was initiated because the volume markings on the cups are incorrect. Specifically, the text "5 mL" is printed next to the increment that should read "10 mL." While the other gradations are marked correctly, the sequence is listed as 2.5 mL, 5 mL, 7.5 mL, and 5 mL. This labeling error could lead to inaccurate measurement of liquid medication.
Consumers and healthcare facilities should stop using the affected medicine cups and contact Medline Industries for instructions on how to return or dispose of the product.
The recalled product
- Product
- Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Dosing Devices
- Hazard
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 (1)
- Lot Numbers 122211502 122212515
Distribution
Distribution scope not specified by the agency.
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 · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateMedline Medical Soft Liner Recall Due to Dimensional Variation
FDA (Devices) · 2024-08-28
- HighMedline Luer Slip Syringes Recalled for Inaccurate Volume Delivery
FDA (Devices) · 2024-06-12
- HighMedline Disposable Syringes Recalled for Inaccurate Volume Delivery
FDA (Devices) · 2024-06-12
- ModerateMedline Sodium Chloride Injection Recalled for Incorrect Overwrap Packaging
FDA (Devices) · 2018-09-05
- SevereMedline Acetaminophen Tablets Recalled for Incorrect Strength Labeling
FDA (Drugs) · 2016-02-24
- ModerateMerit Medical Systems Recalls 1mL Medallion Syringes Due to Plunger Defect
FDA (Devices) · 2018-08-22