The Recall Desk
ModerateFDA (Devices)·Z-2057-2016·Announced 2016-07-06

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.

What this means for you

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

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

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Same manufacturer · Dynarex Corporation

See all →