High FDA (Devices)·Z-2187-2023·Announced 2023-07-26

Medline Ultrasound Probe Covers Recalled for Seam Barrier Defects

Medline is recalling ultrasound probe cover kits with sterile gel due to inadequate seam barriers that may compromise sterility during diagnostic procedures. Approximately 8,974 units distributed worldwide from 2017 to 2023 are affected.

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 recall for a sterile medical device with a defect that poses a potential contamination risk during clinical use. The barrier defect represents a risk-of-harm product where no illnesses or injuries have been reported, meeting the criterion for a High severity score.

Plain-English summary

Medline Industries is recalling Probe Cover Kits containing sterile Ultrasound Gel used during diagnostic ultrasound procedures. The kits include six model numbers: DYNDV2200, DYNDV2397, DYNJ24276C, DYNJ66041, DYNJ66041A, and DYNJ66041B.

The recalled probe covers may have an inadequate barrier at the seams. This defect affects the integrity of the protective covering, which is critical for maintaining sterility during ultrasound procedures.

Approximately 8,974 units are affected. All lots within their expiration dates distributed between December 2017 and May 2023 are included in the recall. The affected units were distributed to customers in the United States and internationally, including the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

The recalled product

Product: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200; b) ULTRASOUND PIV KIT, Model Number DYNDV2397; c) VAD ACCESS, Model Number DYNJ24276C; d) FETAL INTERVENTION, Model Number DYNJ66041; e) FE
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Ultrasound Probe Covers
Hazard: barrier-defect
contamination-risk
Affected units: 8,974

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 (18)

all lots within expiry
UDI/DI (EA) 10888277742550
UDI/DI (CS) 40888277742551
b) Model Number DYNDV2397
UDI/DI (EA) 10193489388466
UDI/DI (CS) 40193489388467
c) Model Number DYNJ24276C
UDI/DI (EA) 10884389431184
UDI/DI (CS) 40884389431185
d) Model Number DYNJ66041
UDI/DI (EA) 10193489315820
UDI/DI (CS) 40193489315821
e) Model Number DYNJ66041A
UDI/DI (EA) 10193489480283
UDI/DI (CS) 40193489480284
f) Model Number DYNJ66041B
UDI/DI (EA) 10195327151072
UDI/DI (CS) 40195327151073

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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