The Recall Desk
HighFDA (Devices)·Z-2192-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits Recalled for Inadequate Sterile Barrier

Medline Probe Cover Kits used during ultrasound procedures may have an inadequate barrier at the seams that could compromise sterility. The manufacturer is recalling 180 units distributed worldwide between December 2017 and May 2023.

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 medical device recall involving a structural defect (inadequate sterile barrier) on equipment used in sterile medical procedures. Although no injuries or illnesses have been reported, the compromised barrier presents a risk of contamination or infection during diagnostic ultrasound procedures, meeting the criterion for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling Probe Cover Kits (Model Number DYNJ44322G) containing sterile ultrasound gel used during diagnostic ultrasound procedures. The kits may have an inadequate barrier at the seams, which could compromise the integrity of the sterile barrier during clinical use.

This recall affects 180 units distributed worldwide between December 2017 and May 2023. Distribution includes the United States and the following countries: United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

Affected units can be identified by Model Number DYNJ44322G, UDI/DI (EA) 10889942646661, or UDI/DI (CS) 40889942646662. Healthcare facilities and clinicians who possess these kits should stop using them and contact Medline Industries, LP for return instructions or replacement.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number DYNJ44322G
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound Accessories
Hazard
  • inadequate-sterile-barrier
  • contamination-risk

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)

  • all lots within expiry
  • UDI/DI (EA) 10889942646661
  • UDI/DI (CS) 40889942646662

Distribution

Distributed nationwide across the United States.

Related recalls

Same category