The Recall Desk
HighFDA (Devices)·Z-2162-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier

Medline is recalling ultrasound probe cover kits due to inadequate barrier protection at the seams, which may allow contamination during diagnostic procedures. The recall affects multiple model numbers 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: This is a Class II medical device recall affecting a risk-of-harm product—ultrasound probe covers used in sterile medical procedures. The inadequate barrier at seams creates potential for contamination. No illnesses or injuries have been reported, and the hazard is not yet manifested in clinical outcomes. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

Medline Industries, LP is recalling sterile ultrasound probe cover kits distributed under 18 different model numbers, including CATH PACK (DYNJ83105), TESIO (DYNJ83251), ANGIOGRAPHY PACK variants (DYNJ83508, DYNJ83656), and others, all containing sterile ultrasound gel.

The probe covers may have an inadequate barrier at the seams. This defect could compromise the protective function of the probe covers during diagnostic ultrasound procedures.

Approximately 3,740,814 units were distributed worldwide, including throughout the United States and to the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. All affected lots were distributed between December 2017 and May 2023 and were within expiry at the time of recall.

Users and healthcare facilities should immediately discontinue use of affected probe cover kits. Contact Medline Industries, LP for instructions on returning or replacing affected products.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105; b) TESIO, Model Number DYNJ83251; c) ANGIOGRAPHY PACK-LF, Model Number DYNJ83508; d) OR ANGIOGRAM PACK-LF, Model Number DYNJ83656; e) FERRELL-DUCAN ANG
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound / Diagnostic
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)10195327231514
  • UDI/DI (CS)40195327231515
  • b) Model Number DYNJ83251
  • UDI/DI (EA)10195327248659
  • UDI/DI (CS)40195327248650
  • c) Model Number DYNJ83508
  • UDI/DI (EA)10195327273163
  • UDI/DI (CS)40195327273164
  • d) Model Number DYNJ83656
  • UDI/DI (EA)10195327288228
  • UDI/DI (CS)40195327288229
  • e) Model Number DYNJ83696
  • UDI/DI (EA)10195327299125
  • UDI/DI (CS)40195327299126
  • f) Model Number DYNJ83746
  • UDI/DI (EA)10195327300692
  • UDI/DI (CS)40195327300693
  • g) Model Number DYNJ83815
  • UDI/DI (EA)10195327311018

Distribution

Distributed nationwide across the United States.

Related recalls

Same category