The Recall Desk
HighFDA (Devices)·Z-2169-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier

Medline is recalling 770,147 ultrasound probe cover kits worldwide due to inadequate barriers at the seams. The defect could allow contamination 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: Class II medical device recall for probe covers used in diagnostic procedures. The inadequate seam barrier creates a risk of contamination during patient procedures, and no injuries have been reported, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Medline Industries, LP is recalling 770,147 ultrasound probe cover kits containing sterile gel. These kits are used in various diagnostic and surgical procedures and were distributed worldwide between December 2017 and May 2023.

The probe covers have an inadequate barrier at the seams, which may allow contamination to occur during diagnostic ultrasound procedures, potentially affecting patient safety. The recall affects 18 different model numbers used across multiple procedure types, including fetal surgery, bariatric, ablation, endoluminal, thyroid, and laparoscopy procedures.

Affected distributions span the United States and nine other countries: the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, and Panama. Specific model numbers, UDI codes, and complete distribution details are available from the FDA.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYNDA2418; c) CLOSUREFAST PROCEDURE PACK-LF, Model Number DYNJ0365463J; d) BARIATRIC PACK, Model Nu
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound / Diagnostic Equipment
Hazard
  • inadequate-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 (20)

  • all lots within expiry
  • UDI/DI (EA) 10195327289904
  • UDI/DI (CS) 40195327289905
  • b) Model Number DYNDA2418
  • UDI/DI (EA) 10193489378214
  • UDI/DI (CS) 40193489378215
  • c) Model Number DYNJ0365463J
  • UDI/DI (EA) 10193489783872
  • UDI/DI (CS) 40193489783873
  • d) Model Number DYNJ24459P
  • UDI/DI (EA) 10193489355345
  • UDI/DI (CS) 40193489355346
  • e) Model Number DYNJ40629B
  • UDI/DI (EA) 10888277778696
  • UDI/DI (CS) 40888277778697
  • f) Model Number DYNJ44210B
  • UDI/DI (EA) 10193489306859
  • UDI/DI (CS) 40193489306850
  • g) Model Number DYNJ47716C
  • UDI/DI (EA) 10195327355296

Distribution

Distributed nationwide across the United States.

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