High FDA (Devices)·Z-2310-2023·Announced 2023-08-09

Custom Procedural Kits with Ultrasound Gel May Not Meet Sterility Standards

Medline recalls 4,618 custom sterile procedural kits distributed worldwide from April 2020 through April 2023. The Turkuaz ultrasound gel component may not meet sterility specifications, posing a potential infection risk in surgical procedures.

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: FDA Class II recall of a sterility specification failure in medical device components used in invasive surgical procedures. No illnesses or injuries have been reported. This constitutes a risk-of-harm product where injury has not yet been reported, fitting the High (3) category.

Plain-English summary

Medline Industries, LP is recalling custom sterile and non-sterile procedural kits containing Turkuaz ultrasound gel. The recalled kits include DBD-PACK FETOSCOPY (model DYNJ906905B), FETOSCOPY CDS-LF (model CDS840215O), PACK FETOSCOPY (model DYNJ906905A), and US BREAST BIOPSY TRAY (model DYNDH1187A). A total of 4,618 kits were distributed.

The ultrasound gel component labeled as sterile in some of these kits may not meet required sterility specifications. When non-sterile gel is used in sterile surgical procedures such as fetoscopy and breast biopsy, it poses a potential risk of infection to patients.

The affected kits were distributed worldwide, including to facilities in the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. All lot numbers of the four models listed above distributed between April 1, 2020 and April 28, 2023 are included in this recall.

Consumers and healthcare facilities should immediately cease use of affected kits and contact Medline Industries for instructions on how to handle the recalled products.

The recalled product

Product: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-PACK FETOSCOPY, Model Number: DYNJ906905B; b. FETOSCOPY CDS-LF, Model Number: CDS840215O; c. PACK,FETOSCOPY, Model Number: DYNJ906905A; d. US BR
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical and Procedural Kits
Hazard: sterility-failure
contamination-risk
infection-risk
Affected units: 4,618

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 (4)

UPC Number: 019348988494. b. Model Number: CDS840215O
UPC Number: 019348944899. c. Model Number: DYNJ906905A
UPC Number: 019348939112. d. Model Number: DYNDH1187A
UPC Number: 088994270263.

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.

See all 50 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

See all →

Critical
Intubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
Severe
Medline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
High
Good Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
High
Surgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
High
Surgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03

Same hazard · sterility failure