Medline Ultrasound Gel in Surgical Kits May Not Meet Sterility Standards
Medline is recalling approximately 9,017 breast biopsy and ultrasound surgical kits due to potential sterility failures in the included ultrasound gel component. No illnesses have been reported.
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: FDA Class II recall involving potential sterility failure in a surgical component. While no illnesses or injuries have been reported and the hazard is theoretical, non-sterile components in medical devices used in invasive procedures represent a significant risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling approximately 9,017 breast biopsy and ultrasound surgical kits. The affected products include six models of sterile and non-sterile procedural kits that contain Turkuaz ultrasound gel: Breast Biopsy Kit models DYNDA1224A and DYNDA1224B, Breast Biopsy Tray model SPEC0130C, Breast Imaging Tray model MNS11895, Ultrasound Breast Biopsy model DYNDH1496, Ultrasound Guide Breast Biopsy model DYNDH1319, and US Breast Biopsy Tray model DYNDH1187A. All lot numbers for these models distributed between April 1, 2020 and April 28, 2023 are included in the recall.
The ultrasound gel component in these kits may not meet sterility specifications required for safe use in sterile medical procedures. If non-sterile gel is used during a breast biopsy or ultrasound-guided procedure, it could introduce contamination and pose a risk of infection.
The recalled kits were distributed worldwide, including throughout the United States and to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. Healthcare facilities and clinicians should stop using these kits immediately and contact Medline for replacement units or instructions on product disposition. No illnesses or injuries have been reported in association with these products.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. BREAST BIOPSY KIT, Model Number: DYNDA1224A, DYNDA1224B; b. BREAST BIOPSY TRAY, Model Number: SPEC0130C; c. BREAST IMAGING TRAY, Model Number: MNS11895…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 9,017
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 (8)
- UPC Number: 10888277985643
- Model Number: DYNDA1224B
- UPC Number: 10193489191448. b. Model Number: SPEC0130C
- UPC Number: 10193489196641. c. Model Number: MNS11895
- UPC Number: 10653160324645. d. Model Number: DYNDH1496
- UPC Number: 10193489193947. e. Model Number: DYNDH1319
- UPC Number: 10889942795475. f. Model Number: DYNDH1187A
- UPC Number: 10889942702633.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 50 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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