Medline Surgical Procedural Kits Recalled Due to Sterility Concerns
Medline Industries is recalling approximately 7,462 custom surgical procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall affects kits distributed worldwide since April 2020.
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 a risk-of-harm product (sterile medical device kits for invasive procedures) where potential sterility failure presents infection risk. No illnesses or injuries have been reported, placing it at the maximum of score 3 per the rubric for products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 7,462 custom sterile and non-sterile procedural kits containing Turkuaz ultrasound gel. The affected kits include models used for prostate, gynecological, amniocentesis, and robotic-assisted surgical procedures.
The recall is being issued because the labeled sterile ultrasound gel component within these kits may not meet sterility specifications. This potential deficiency could compromise the intended sterile condition of the kits used in clinical settings.
The affected 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. All lot numbers of the affected models distributed between April 1, 2020, and April 28, 2023, are included in the recall.
Customers in possession of affected kits should stop use and contact Medline Industries for instructions on product return or replacement.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N; b. CUSTOM GYN, Model Number: DYNJ63257B; c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 7,462
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: 019348991666. b. Model Number: DYNJ63257B
- UPC Number: 019348942817. c. Model Number: DYNJ0771979C
- UPC Number: 019348940069. d. Model Number: DYNJ906578F
- UPC Number: 019532728963. e. Model Number: DYNJ906579F
- UPC Number: 019532728964. f. Model Number: DYNJ906616G
- UPC Number: 019532728947. g. Model Number: DYNJ905824I
- UPC Number: 019532728972. h. Model Number: DYNJ906578D
- UPC Number: 019532721712. i. Model Number: DYNJ906579A
- UPC Number: 019348942214
- Model Number: DYNJ906579B
- UPC Number: 019348986153
- Model Number: DYNJ906579D
- UPC Number: 019532721713
- Model Number: DYNJ906579F
- UPC Number: 019532728964. j. Model Number: DYNJ906616A
- UPC Number: 019348942213
- Model Number: DYNJ906616B
- UPC Number: 019348986167
- Model Number: DYNJ906616C
- UPC Number: 019532702358
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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