The Recall Desk
HighFDA (Devices)·Z-2172-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers

Medline is recalling probe cover kits used with diagnostic ultrasound procedures due to inadequate seam barriers that may compromise sterility. The recall affects 1,861 units distributed worldwide from December 2017 through 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: FDA Class II medical device recall for seam barrier defect that may compromise sterility during ultrasound procedures. No reported illnesses or injuries; this is a risk-of-harm product without documented harm, meeting the High severity criterion.

Plain-English summary

Medline Industries, LP is recalling probe cover kits containing sterile ultrasound gel used during diagnostic ultrasound procedures. Eight model numbers are affected, totaling 1,861 units.

The probe covers may have inadequate barriers at the seams, potentially compromising their ability to maintain sterility during procedures.

The affected products were distributed worldwide from December 2017 through May 2023 to the United States and internationally, including the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

No illnesses or injuries associated with these products have been reported to date. Healthcare providers who have these probe cover kits should discontinue use and contact Medline Industries for instructions on replacement or return.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS, Model Number CDS983069I; b) HEAD AND NECK PACK, Model Number DYNJ30245; c) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716B; d) CENTRAL LINE INSERTI
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Diagnostic Ultrasound
Hazard
  • sterile-barrier-defect
  • 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 (20)

  • all lots within expiry
  • UDI/DI (EA) 10195327071868
  • UDI/DI (CS) 40195327071869
  • b) Model Number DYNJ30245
  • UDI/DI (EA) 10080196787692
  • UDI/DI (CS) 40080196787693
  • c) Model Number DYNJ47716B
  • UDI/DI (EA) 10193489454536
  • UDI/DI (CS) 40193489454537
  • d) Model Number DYNJ63347A
  • UDI/DI (EA) 10193489278064
  • UDI/DI (CS) 40193489278065
  • e) Model Number DYNJ63634A
  • UDI/DI (EA) 10195327143046
  • UDI/DI (CS) 40195327143047
  • f) Model Number DYNJ81389A
  • UDI/DI (EA) 10195327176785
  • UDI/DI (CS) 40195327176786
  • g) Model Number DYNJ83960
  • UDI/DI (EA) 10195327319991

Distribution

Distributed nationwide across the United States.

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