SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000

FDA device recall Z-0921-2026 · posted 2025-12-12 · Open, Classified

Recall details

Recalling firm

Medline Industries, LP

Reason for recall

The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.

Action taken

An URGENT MEDICAL DEVICE RECALL notification letter dated 11/13/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed on the enclosed response form. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please complete and return the enclosed response form listing the quantity of affected product you have in inventory. Even if you do not have any affected product in inventory, please complete and return the response form. 3. Your account will receive credit once the response form is submitted, if applicable. 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Root cause

Packaging process control

Status

Open, Classified

Product code

LRW

Quantity affected

56 units

Distribution

US Nationwide distribution in the states CA, CO, IL, KS, and MI.

Date initiated

2025-11-13

Date posted

2025-12-12

Location

Northfield, IL