Dynarex Recalls Specimen Containers Due to Incorrect Sterile Labeling
Dynarex Corporation is recalling non-sterile specimen containers that were mistakenly packed in cartons labeled as sterile. The recall covers specific lots distributed in the US and Canada.
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 involves a minor labeling error where non-sterile items were packed in cartons labeled as sterile. No injuries or illnesses are reported in the source text.
Plain-English summary
Dynarex Corporation is recalling Dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only. The recall is due to a labeling error where non-sterile, bulk specimen containers were packed in exterior cartons that were mis-labeled as sterile.
The affected product quantity is 399 cases, 25 sleeves, and 20 cups and lids per sleeve. The specific lot numbers involved are 31899, 32014, 32015, 32410, and 32411. These products were distributed nationwide in the United States in the states of Alabama, Arkansas, Florida, Georgia, Massachusetts, North Carolina, New York, New Jersey, New Hampshire, Pennsylvania, Ohio, Texas, and Virginia, as well as internationally in Canada.
This recall is classified as Class II by the FDA. Consumers and healthcare facilities should check their inventory for these specific lot numbers and stop using the affected containers if they are present.
The recalled product
- Product
- dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
- Manufacturer
- Dynarex Corporation
- 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 (4)
- Lot Numbers: 31899
- 32014
- 32015
- 32410 & 32411
Distribution
Related recalls
Same manufacturer · Dynarex Corporation
See all →- ModerateDynarex Oxygen Regulator Recalled for Inaccurate Flow Rate Indicator
FDA (Devices) · 2018-06-06
- ModerateDynarex CPR Shield Recalled for Incorrect Orientation Labeling
FDA (Devices) · 2014-08-06
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
- HighClean Catch Kit specimen containers recalled for sterility labeling failure
FDA (Devices) · 2024-11-20
- HighMedical Laboratory Kit Recalled Due to Non-Sterile Specimen Container
FDA (Devices) · 2024-11-20
- ModerateRecall of Sterile Specimen Containers Due to Packaging Defect
FDA (Devices) · 2016-12-21
- HighUrine kit specimen containers recalled for non-sterile condition
FDA (Devices) · 2024-11-20
- HighUA Kit Specimen Containers Identified as Non-Sterile Despite Sterile Labeling
FDA (Devices) · 2024-11-20
- HighMedline Urine Collection Kits Recalled Due to Non-Sterile Specimen Containers
FDA (Devices) · 2024-11-20