Agency classClass IIOur severity:High FDA (Devices)·Z-2154-2023·Announced 2023-07-26

Medline ultrasound probe cover kits recalled for inadequate seam barriers

Medline Industries has recalled 1,505,262 Probe Cover Kits used in diagnostic ultrasound procedures due to an inadequate barrier at the seams. The recall affects units distributed worldwide between December 2017 and May 2023.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 FDA recall for an inadequate barrier at the seams of diagnostic ultrasound probe covers. No illnesses or injuries are reported in connection with this defect. Per the rubric, risk-of-harm products with no reported injury are scored at 3 (High).

Plain-English summary

Medline Industries, LP has recalled Probe Cover Kits (model numbers DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, and DYNJEX5900) used during diagnostic ultrasound procedures. A total of 1,505,262 kits distributed between December 2017 and May 2023 are affected.

The probe covers have an inadequate barrier at the seams. This defect creates a risk of contamination during diagnostic ultrasound procedures.

The recalled kits were distributed worldwide, including to the United States and to customers in the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

Healthcare providers and medical facilities using these probe covers should stop using affected units and contact Medline Industries for replacement kits.

The recalled product

Product: Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Ultrasound Equipment
Hazard: barrier-defect
contamination-risk
Affected units: 1,505,262

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 (12)

All lots within expiry
Case: 40884389114125)
DYNJE5910 (Each: 10884389114094
Case: 40884389114095)
DYNJE5920 (Each: 10884389114100
Case: 40884389114101)
DYNJE5930 (Each: 10884389114117
Case: 40884389114118)
DYNJE5940 (Each: 10888277723641
Case: 20888277723648)
DYNJEX5900 (Each: 10884389114124
Case: 40884389114125). All lots within their expiration date.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 52 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 52 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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