FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
Recall
- Recall Number
- Z-0922-2026
- Event Number
- 98066
- FEI Number
- 1417592
- Product Code
- LRW
- Status
- Open, Classified
- Root Cause
- Packaging process control
- Initiated
- November 13, 2025
- Posted
- December 12, 2025
- Address
- 3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753
Description
FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
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.
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 [email protected].
US Nationwide distribution in the states CA, CO, IL, KS, and MI.
53 units