The Recall Desk
HighFDA (Devices)·Z-2205-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier

Medline Industries is recalling 4,500 Probe Cover Kits because the covers have inadequate barriers at the seams, which may compromise sterility.

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 a Class II FDA recall for a medical device with a structural defect at the seams that may compromise sterility. No illnesses or injuries have been reported, but the inadequate barrier poses a theoretical risk of contamination and potential infection, fitting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling Probe Cover Kits containing sterile Ultrasound Gel. These probe cover kits are used to cover diagnostic ultrasound equipment during clinical procedures. Approximately 4,500 units were distributed worldwide, including throughout the United States and internationally to the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. Products were distributed between December 2017 and May 2023.

The recalled probe covers have an inadequate barrier at the seams. This defect may compromise the sterility of the covers, potentially exposing the device to contamination during use.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TO
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound Supplies
Hazard
  • seam-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)

  • a) Model Number CDS985555S
  • UDI/DI (EA) 10195327343798
  • UDI/DI (CS) 40195327343799
  • b) Model Number CDS985566Q
  • UDI/DI (EA) 10195327074418
  • UDI/DI (CS) 40195327074419
  • c) Model Number DYNJ0949139I
  • UDI/DI (EA) 10195327195366
  • UDI/DI (CS) 40195327195367
  • d) Model Number DYNJ24525K
  • UDI/DI (EA) 10195327135751
  • UDI/DI (CS) 40195327135752
  • e) Model Number DYNJ24526P
  • UDI/DI (EA) 10195327135744
  • UDI/DI (CS) 40195327135745
  • f) Model Number DYNJ26425L
  • UDI/DI (EA) 10195327156985
  • UDI/DI (CS) 40195327156986
  • g) Model Number DYNJ44635I
  • UDI/DI (EA) 10193489958553

Distribution

Distributed nationwide across the United States.

Related recalls

Same category