The Recall Desk
HighFDA (Devices)·Z-1453-2024·Announced 2024-04-10

Medline Swabsticks PVP Product Recalled for Weak Seal Risk

Medline Industries is recalling Swabsticks PVP swabs (2,458 units) due to weak seals that may compromise sterility. The defect may not be visible to users.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a potential sterility breach in a medical device. No illnesses or injuries have been reported. The hazard constitutes a risk-of-harm product where injury has not yet been reported, qualifying it as High severity.

Plain-English summary

Medline Industries, LP is recalling Medline Swabsticks PVP 3 Packs (Product Code DYNDA2724) manufactured in lots 2023071290 and 2023091890. Approximately 2,458 units have been distributed in the United States, Canada, and Panama.

The products may have weak seals that could fail and compromise the sterility of the contents. The weak seal defect may not be noticeable to users during normal inspection or use.

Sterile medical devices are used in healthcare applications. If the seal is compromised, the product contents may be exposed to contamination, potentially affecting the safety and function of the device.

Consumers and healthcare facilities with these products should discontinue use and contact the manufacturer for instructions on product return or replacement.

The recalled product

Product
MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • weak-seal
  • sterility-breach

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 (3)

  • UDI/DI 20193489190790 (case) 10193489190793 (each)
  • Lot Numbers: 2023071290
  • 2023091890

Distribution

Distributed nationwide across the United States.