FDA Device recall Z-2171-2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F
- FDA Device
- Class II
- ongoing
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F by Medline Industries Northfield, citing probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2171-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-18 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F
Reason
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Identifiers
| code_info | all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number OST011F, UDI/DI (EA)…all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number OST011F, UDI/DI (EA) 10195327091347, UDI/DI (CS) 40195327091348 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2171-2023%22
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