Medical procedural kits recalled for potential sterile ultrasound gel defect
Medline is recalling 93,587 custom procedural kits worldwide because the sterile ultrasound gel component may not meet sterility specifications.
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: This is an FDA Class II medical device recall for procedural kits with a potential sterility specification failure on the ultrasound gel component. No illnesses or injuries have been reported. This represents a high-risk scenario for medical procedures, but without reported harm, it falls under the category of risk-of-harm products without reported injury, meeting the criteria for Score 3.
Plain-English summary
Medline Industries, LP is recalling 93,587 custom sterile and non-sterile procedural kits because the labeled sterile ultrasound gel component may not meet sterility specifications. These kits are used in various medical procedures across multiple surgical specialties.
The affected kits were distributed worldwide from April 1, 2020 through April 28, 2023. Distribution included the United States and the following international locations: Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. The FDA has provided model numbers, UPC codes, and lot number information for healthcare facilities to identify affected products.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 93,587
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 (20)
- UPC Number: 019348940782. b. Model Number: DYNJ51416B
- UPC Number: 088827774647. c. Model Number: DYNJ42913
- UPC Number: 088827701320
- Model Number: DYNJ42913A
- UPC Number: 019532708060. d. Model Number: DYNJ61243
- UPC Number: 019348955091. e. Model Number: DYNJ66291
- UPC Number: 019348932808
- Model Number: DYNJ66291A
- UPC Number: 019348948000. f. Model Number: DYNJ57449A
- UPC Number: 088994282753. g. Model Number: DYNJ26940G
- UPC Number: 019348954079. h. Model Number: DYNJ60126
- UPC Number: 088994295193. i. Model Number: DYNJ54265
- UPC Number: 088994247400. j. Model Number: DYNJ59085
- UPC Number: 088994293201. k. Model Number: DYNJ42831D
- UPC Number: 088994284953. l. Model Number: DYNJ53435C
- UPC Number: 019348920086. m. Model Number: DYNJ48456B
- UPC Number: 088994273317. n. Model Number: DYNJ59168
- UPC Number: 088827776444. o. Model Number: DYNJ58228
- UPC Number: 088994283549. p. Model Number: DYNJ62443
- UPC Number: 019348967919. q. Model Number: DYNJ59392C
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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