Procedural Kits with Ultrasound Gel May Not Meet Sterility Standards
Medline is recalling 1,130 custom sterile procedural kits because the ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide from April 2020 to April 2023.
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: This recall involves a potential sterility specification failure on a medical device component used in clinical procedures, representing a risk of harm through possible contamination. The source does not report any illnesses or injuries, making this a theoretical hazard situation that warrants a score of 3 per the rubric.
Plain-English summary
Medline Industries is recalling 1,130 custom sterile and non-sterile procedural kits labeled as STERILE SET FOR IMPLANT-LF (Model OST011F) that contain Turkuaz ultrasound gel.
The ultrasound gel component within these kits may not meet sterility specifications. Because these sterile procedural kits are used in medical implant procedures, failure to meet sterility standards could result in contamination.
These kits were distributed worldwide, including throughout the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. All lot numbers of Model OST011F with UPC 019532709134 distributed between April 1, 2020, and April 28, 2023, are affected.
Consumers and healthcare providers who have these kits should discontinue use and contact Medline Industries or their supplier for instructions on return or replacement. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF, Model Number: OST011F.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kits
- Hazard
- contamination
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 (1)
- UPC Number: 019532709134
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27