FDA Medical devices recall ·
Medline Shoulder Repair Pack-LF recall
- Recall number
- Z-0534-2025
- Date
- (initiated October 15, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 48 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
Why was it recalled?
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot number 24ABO552, exp. 9/30/2025, UDI-DI each 10195327198930, UDI-DI case 40195327198931.
Distribution
US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
States: Alabama Georgia Massachusetts New Jersey Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0534-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.