The Recall Desk
HighFDA (Devices)·Z-2163-2023·Announced 2023-07-26

Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers

Medline is recalling 172,722 ultrasound probe cover kits due to inadequate barrier protection at the seams. The defect may compromise protective function during diagnostic ultrasound procedures.

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 inadequate barrier protection on ultrasound probe covers. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in a High severity score.

Plain-English summary

Medline Industries, LP is recalling probe cover kits containing sterile ultrasound gel used during diagnostic ultrasound procedures. The affected units may have an inadequate barrier at the seams, which could compromise the protective function of the covers.

The recall affects approximately 172,722 units across multiple model numbers and branded configurations. The products were distributed worldwide between December 2017 and May 2023 to the United States and international locations including the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

Healthcare facilities have been notified of the recall. Specific model numbers, UDI codes, and detailed distribution information are available in the official FDA recall notice.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I; c. BAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I; d. ENDOVASCULAR
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound Probe Cover
Hazard
  • barrier-failure
  • 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) 10193489489088
  • UDI/DI (CS)40193489489089
  • b) Model Number CDS840487I
  • UDI/DI (EA) 10193489445343
  • UDI/DI (CS)40193489445344
  • c) Model Number CDS983147I
  • UDI/DI (EA) 10195327075514
  • UDI/DI (CS)40195327075515
  • d) Model Number CDS983394I
  • UDI/DI (EA) 10193489819953
  • UDI/DI (CS)40193489819954
  • e) Model Number CDS983394J
  • UDI/DI (EA) 10195327069872
  • UDI/DI (CS)40195327069873
  • f) Model Number CDS983394K
  • UDI/DI (EA) 10195327292584
  • UDI/DI (CS)40195327292585
  • g) Model Number CDS983513F
  • UDI/DI (EA) 10193489843729

Distribution

Distributed nationwide across the United States.

Related recalls

Same category