The Recall Desk
HighFDA (Devices)·Z-0532-2025·Announced 2024-12-04

Medline Surgical Kits Recalled for Incorrect Needle and Suture Specifications

Medline Industries is recalling 408 surgical kits from Alabama, Georgia, Massachusetts, New Jersey, and Pennsylvania. Some suture packages within the kits contain incorrect needle types and sizes, and incorrect suture diameters and lengths.

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 of surgical supplies with no reported hospitalizations or illnesses. The defect in critical surgical components (incorrect needle types, sizes, and suture specifications) constitutes a risk-of-harm product meeting the rubric criterion for High severity.

Plain-English summary

Medline Industries, LP is recalling approximately 408 surgical kits due to defects in included suture packages. The affected products are the Medline Open Heart CDS (REF CDS840132O) and the Medline Dr. Davies CV (REF DYNJ903016G).

Some suture packages within these convenience kits contain incorrect needle types and sizes, along with incorrect suture diameters and lengths. These defects could potentially affect surgical outcomes if the incorrect components are used during procedures.

The affected kits were distributed to medical facilities in Alabama, Georgia, Massachusetts, New Jersey, and Pennsylvania. Specific lot numbers and expiration dates are identified in the FDA's official recall database.

Healthcare facilities with these kits should discontinue use immediately and contact Medline Industries for replacement or disposal. Medical professionals should verify correct needle and suture specifications are available before proceeding with surgical procedures.

The recalled product

Product
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits
Hazard
  • incorrect-needle-type
  • incorrect-needle-size
  • incorrect-suture-diameter
  • incorrect-suture-length

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 (10)

  • (1) REF CDS840132O - Lot number 24BBF701
  • exp. 10/31/2024
  • UDI-DI each 10195327245276
  • UDI-DI case 40195327245277
  • (2) REF DYNJ903016G - Lot numbers 24DBP801
  • exp. 8/31/2025
  • and 24CBJ749
  • exp. 11/30/2024
  • UDI-DI each - 10195327657154
  • UDI-DI case - 40195327657155.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category