The Recall Desk
HighFDA (Devices)·Z-2173-2023·Announced 2023-07-26

Medline Probe Cover Kits recalled for inadequate seam barriers

Medline Industries is recalling 4,148 units of Probe Cover Kits used in diagnostic ultrasound procedures due to inadequate barriers at the seams.

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 recall involving a physical defect (inadequate barrier at seams) in a medical device used in diagnostic procedures. No adverse events or illnesses have been reported. Per the severity rubric, this qualifies as a risk-of-harm product without reported injury.

Plain-English summary

Medline Industries is recalling 4,148 units of Probe Cover Kits containing sterile Ultrasound Gel used during diagnostic ultrasound procedures. The recall is due to the identification that these probe covers may have an inadequate barrier at the seams.

Three models are included in this recall: FETOSCOPY CDS-LF (Model CDS840215O), US BREAST BIOPSY TRAY (Model DYNDH1187A), and PACK, FETOSCOPY (Model DYNJ906905B). All lots within the expiration date distributed from December 2017 through May 2023 are affected.

The recalled products were distributed worldwide between December 2017 and May 2023. Distribution included the United States and the following countries: United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

This recall was announced by the FDA under recall number Z-2173-2023.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Number CDS840215O; b) US BREAST BIOPSY TRAY, Model Number DYNDH1187A; c) PACK,FETOSCOPY, Model Number DYNJ906905B
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound / Probe Covers
Hazard
  • 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 (9)

  • all lots within expiry
  • UDI/DI (EA) 10193489448993
  • UDI/DI (CS) 40193489448994
  • b) Model Number DYNDH1187A
  • UDI/DI (EA) 10889942702633
  • UDI/DI (CS) 40889942702634
  • c) Model Number DYNJ906905B
  • UDI/DI (EA) 10193489884944
  • UDI/DI (CS) 40193489884945

Distribution

Distributed nationwide across the United States.

Related recalls

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