Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline is recalling ultrasound probe cover kits for an inadequate barrier at the seams that could compromise sterility. The recall affects 1,130 units distributed worldwide.
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: Class II medical device recall involving a sterile barrier defect with no reported illnesses or injuries. This represents a risk-of-harm product where injury has not yet been reported, meeting the High severity criteria.
Plain-English summary
Medline Industries is recalling Probe Cover Kits (Model OST011F) containing sterile ultrasound gel because the kits may have an inadequate barrier at the seams. This defect could compromise the sterile barrier during diagnostic ultrasound procedures.
The recall affects 1,130 units that were distributed worldwide between December 2017 and May 2023. Distribution included the United States (nationwide) and nine other countries: United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. The affected units are identified by Model Number OST011F and specific UDI/DI codes.
No illnesses or injuries associated with this defect have been reported.
The recalled product
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,130
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 (3)
- all lots within expiry
- UDI/DI (EA) 10195327091347
- UDI/DI (CS) 40195327091348
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.
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