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.
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: 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
- Affected units
- 48
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
Part of a larger recall action
This product is one of 3 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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