CLASS II ONGOING Device recall · Reported 26 Jul 2023 · FDA Enforcement Report
Medline Probe Cover Kits containing sterile Ultrasound Gel recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a), distributed nationwide in the US. The recall was initiated on 18 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2183-2023
- FDA event ID
- 92466
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 May 2023
- FDA classified
- 20 Jul 2023
- Reported
- 26 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Imaging Equipment
Timeline
| 18 May 2023 | Recall initiated by company | |
| 20 Jul 2023 | Classified by FDA | +63 days |
| 26 Jul 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Number DYNDV2407A; b) USG IV START KIT, Model Number DYNDV2435; c) ULTRASOUND GUIDED IV START KIT, Model Number DYNDV2518; d) VI PACK, Model Number DYNJ64871
Where it was distributed
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Stores named: Walmart
Questions about this recall
Is Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) on 18 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-2183-2023.
Why was it recalled?
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Which lots are affected?
all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDV2407A, UDI/DI (EA) 10193489817010UDI/DI (CS) 40193489817011; b) Model Number DYNDV2435, UDI/DI (EA) 10195327043667UDI/DI (CS) 40195327043668; c) Model Number DYNDV2518, UDI/DI (EA) 10195327089078UDI/DI (CS) 40195327089079; d) Model Number DYNJ64871, UDI/DI (EA) 10193489225365UDI/DI (CS) 40193489225366
Where was it sold?
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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