The Recall Desk
HighFDA (Devices)·Z-0534-2025·Announced 2024-12-04

Medline Shoulder Repair Pack-LF Recalled for Incorrect Surgical Components

Medline is recalling Shoulder Repair Pack-LF surgical kits (lot 24ABO552) due to incorrect needle type/size and suture diameter/length in some packages. No patient injuries have been reported.

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 surgical kits with incorrect component specifications (needle type/size and suture diameter/length). No patient injuries or adverse events reported. This is a risk-of-harm product without reported harm, fitting High severity per the rubric.

Plain-English summary

Medline Industries, LP is recalling Medline Shoulder Repair Pack-LF surgical kits (product code DYNJ82607). The recall involves 48 kits bearing lot number 24ABO552, which expire September 30, 2025.

Some of the suture packages within the convenience kits contain incorrect needle type/size and incorrect suture diameter/length. These components do not match the product's intended specifications.

The affected kits were distributed nationwide to medical facilities in Alabama, Georgia, Massachusetts, New Jersey, and Pennsylvania.

No patient injuries or adverse events have been reported in connection with this recall.

The recalled product

Product
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kit / Orthopedic
Hazard
  • needle-defect
  • suture-defect

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)

  • Lot number 24ABO552
  • exp. 9/30/2025
  • UDI-DI each 10195327198930
  • UDI-DI case 40195327198931.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category