The Recall Desk
HighFDA (Devices)·Z-2191-2023·Announced 2023-07-26

Medline Ultrasound Probe Covers Recalled for Inadequate Sterility Barriers

Medline is recalling ultrasound probe cover kits used in diagnostic procedures because inadequate barriers at the seams may allow bacterial contamination. The recall affects 19,940 units distributed worldwide.

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 with a sterility barrier defect creating risk of infection or contamination during diagnostic procedures. No illnesses or injuries have been reported; the hazard is theoretical. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling ultrasound probe cover kits containing sterile ultrasound gel. The recalled products are used during diagnostic ultrasound procedures and include 30 model variants distributed under various pack names (Craniotomy, Joint Injection, Arthroscopy, Shoulder Arthroscopy, and others). A total of 19,940 units are affected.

The probe covers have an inadequate barrier at the seams. This defect may allow bacterial contamination to breach the sterile barrier during diagnostic procedures, potentially leading to infection or other patient harm.

The recalled products were distributed worldwide from December 2017 through May 2023. Distribution included the United States (nationwide) and eight foreign countries: United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. Affected units can be identified by the specific model numbers and UDI (Unique Device Identifier) codes provided by Medline.

Healthcare providers and facilities using these probe cover kits should stop using the recalled products and contact Medline for instructions on obtaining replacement products or refunds. The FDA and Medline are working to ensure the safety of affected patients and healthcare professionals.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model Number DYNDH1722; c) LOWER EXTREMITY PACK-LF, Model Number DYNJ0604434X; d) ARTHROSCOPY PACK, Model Number D
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound Probe Covers
Hazard
  • barrier-defect
  • contamination-risk
  • infection-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) 10889942208067
  • UDI/DI (CS) 40889942208068
  • b) Model Number DYNDH1722
  • UDI/DI (EA) 10195327132163
  • UDI/DI (CS) 40195327132164
  • c) Model Number DYNJ0604434X
  • UDI/DI (EA) 10889942763801
  • UDI/DI (CS) 40889942763802
  • d) Model Number DYNJ44322I
  • UDI/DI (EA) 10193489530612
  • UDI/DI (CS) 40193489530613
  • e) Model Number DYNJ44348D
  • UDI/DI (EA) 10889942646722
  • UDI/DI (CS) 40889942646723
  • f) Model Number DYNJ44348F
  • UDI/DI (EA) 10193489530650
  • UDI/DI (CS) 40193489530651
  • g) Model Number DYNJ50712C
  • UDI/DI (EA) 10193489870169

Distribution

Distributed nationwide across the United States.

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