The Recall Desk
HighFDA (Devices)·Z-2317-2023·Announced 2023-08-09

Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect

Medline Industries recalled 11,436 procedural kits with Turkuaz ultrasound gel that may not meet sterility specifications. The affected 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 is an FDA Class II recall for a sterile surgical product where the sterile component may not meet specifications. The source reports no illnesses or injuries. It is classified as High because it represents a risk-of-harm product (non-sterile gel in surgical field) without confirmed patient harm.

Plain-English summary

Medline Industries, LP is recalling 11,436 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz ultrasound gel. The recalled kits include dozens of models used in plastic surgery and reconstructive procedures, such as breast reconstruction, free flap procedures, and biopsy operations.

The kits are being recalled because the sterile ultrasound gel component may not meet sterility specifications. Non-sterile gel used in surgical procedures could introduce contamination into the surgical field, potentially causing patient harm through infection.

The affected kits were distributed worldwide between April 1, 2020 and April 28, 2023 to facilities in the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.

Hospitals and surgical facilities using these kits should immediately identify affected inventory by model number and UPC code, remove them from use, and contact Medline Industries for instructions on disposition or replacement.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031; b. BREAST, Model Number: DYNJ904598B; c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits / Ultrasound Gel
Hazard
  • sterility-defect
  • contamination-risk
  • infection-risk

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: 019532725061. b. Model Number: DYNJ904598B
  • UPC Number: 088994294635. c. Model Number: DYNJ63893
  • UPC Number: 019348977156. d. Model Number: DYNDH1306
  • UPC Number: 088994277152. e. Model Number: DYNDH1389B
  • UPC Number: 019348944918. f. Model Number: DYNJ61084A
  • UPC Number: 019348969202. g. Model Number: DYNJ60669F
  • UPC Number: 019532728956. h. Model Number: DYNJ907802
  • UPC Number: 019348989000. i. Model Number: DYNJ83286
  • UPC Number: 019532725665. j. Model Number: DYNJ905004B
  • UPC Number: 019348978258. k. Model Number: SYNJ910024A
  • UPC Number: 019348937448. l. Model Number: DYNJ82250
  • UPC Number: 019532718175. m. Model Number: DYNJ905702C
  • UPC Number: 019532700467
  • Model Number: DYNJ905702D
  • UPC Number: 019532717382. n. Model Number: DYNJ904762D
  • UPC Number: 019532725881. o. Model Number: DYNJ60669C
  • UPC Number: 019532702362
  • Model Number: DYNJ60669D
  • UPC Number: 019532721717. p. Model Number: DYNJ58272C
  • UPC Number: 019348989552

Distribution

Distributed nationwide across the United States.

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