Medline Procedural Kits with Ultrasound Gel Recalled for Sterility Risk
Medline is recalling 3,431 procedural kits because the ultrasound gel component may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 2023.
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 recall involving potential sterility failure of a medical device component used in surgical procedures. The hazard poses a genuine infection risk in clinical settings. No illnesses or injuries have been reported, placing this at the high end of non-critical recalls.
Plain-English summary
Medline Industries is recalling 3,431 sterile and non-sterile procedural kits containing Turkuaz ultrasound gel. The recall is due to a potential sterility failure—the gel component that was labeled as sterile may not meet sterility specifications, creating a potential infection risk.
The affected kits include 17 different models used in surgical and procedural applications, including carotid procedures, central line insertion, thyroid surgery, and head and neck surgery. All lot numbers of the affected models distributed between April 1, 2020 and April 28, 2023 are included in this recall.
The 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.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number: DYNJ54287A; b. CAROTID PACK, Model Number: DYNJ66190; c. CAROTID SUPPLY, Model Number: DYNJ905622C; d. CAROTID-LF, Model…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 3,431
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 (17)
- UPC Number: 088994276521. b. Model Number: DYNJ66190
- UPC Number: 019348932219. c. Model Number: DYNJ905622C
- UPC Number: 019348926350. d. Model Number: DYNJ901745J
- UPC Number: 019348960482. e. Model Number: DYNJ63347A
- UPC Number: 019348927806. f. Model Number: CDS983069G
- UPC Number: 019348992392. g. Model Number: CDS983069I
- UPC Number: 019532707186. h. Model Number: DYNJ47716B
- UPC Number: 019348945453. i. Model Number: SYNJ910018A
- UPC Number: 019348937418. j. Model Number: DYNJ67954A
- UPC Number: 019348995714. k. Model Number: DYNJ65706
- UPC Number: 019348928490. l. Model Number: DYNJ905340A
- UPC Number: 019348950213. m. Model Number: DYNJ20495J
- UPC Number: 019348956435. n. Model Number: DYNJ30245
- UPC Number: 008019678769. o. Model Number: DYNJ43861D
- UPC Number: 088994276328. p. Model Number: DYNJ63634A
- UPC Number: 019532714304. q. Model Number: DYNJ44410F
- UPC Number: 019348981154.
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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