FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
This recall is currently active, issued December 12, 2025.
- Recall Initiated
- November 13, 2025
- Posted
- December 12, 2025
- Recall Number
- Z-0922-2026
- Quantity
- 53 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states CA, CO, IL, KS, and MI.
Lot / Code Info
DYNJ04048, UDI-DI: 10193489195248(each), 20193489195245(case), Lot Number: 2023112290
Root Cause
Packaging process control
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.