The Recall Desk
HighFDA (Devices)·Z-2158-2023·Announced 2023-07-26

Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers

Medline Industries is recalling approximately 23,938 units of sterile ultrasound probe cover kits distributed worldwide from December 2017 to May 2023 due to inadequate barriers at seams that could compromise sterility 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. The product has an actual defect (inadequate seam barriers) that poses a risk to procedure safety and sterility, fitting the criterion for risk-of-harm products where injury has not yet been reported. No illnesses or injuries reported.

Plain-English summary

Medline Industries, LP is recalling multiple sterile ultrasound probe cover kits across 15 product lines, including Nerve Block Accessory Packs, Peri Neuro Block Packs, CVOR Angiography Packs, Block Kit variants, and Radiology-Neuro-IR packs. Approximately 23,938 units with various model numbers were distributed worldwide.

The probe covers may have an inadequate barrier at the seams, which could compromise their protective function during diagnostic ultrasound procedures.

The affected products were distributed to the United States and internationally 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 remain within their expiration dates. Affected products can be identified by the model numbers and UDI codes listed in the recall notice. No illnesses or injuries have been reported to date.

Healthcare facilities and users should discontinue use of affected probe cover kits and contact Medline Industries for replacement or further instructions.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PAC
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound Probe Cover / Diagnostic Ultrasound Accessory
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 (20)

  • all lots within expiry
  • UDI/DI (EA)10888277795037
  • UDI/DI (CS)40888277795038
  • b) Model Number DYNJRA1773
  • UDI/DI (EA)10193489862973
  • UDI/DI (CS)40193489862974
  • c) Model Number DYNJ51107B
  • UDI/DI (EA)10193489810479
  • UDI/DI (CS)40193489810470
  • d) Model Number DYNJ0703127A
  • UDI/DI (EA)10889942084630
  • UDI/DI (CS)40889942084631
  • e) Model Number DYNJ42367B
  • UDI/DI (EA)10193489211511
  • UDI/DI (CS)40193489211512
  • f) Model Number DYNJRA1571
  • UDI/DI (EA)10193489264739
  • UDI/DI (CS)40193489264730
  • g) Model Number DYNJRA0656A
  • UDI/DI (EA)10889942225118

Distribution

Distributed nationwide across the United States.

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