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, 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-2171-2023
- 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
- Other Reasons
- 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.
Product as listed by the FDA
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F
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.
Questions about this recall
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: Model Number OST011F, UDI/DI (EA) 10195327091347, UDI/DI (CS) 40195327091348
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
51 other products · FDA event 92466This product is part of a recall event; the main page for the event is Medline Probe Cover Kits containing sterile Ultrasound Gel recalled.
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