FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ0... – the items may have weak packaging sea... (2025)
Weak packaging seals can potentially compromise medical instrument sterility.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
Lot Codes / Batch Numbers
DYNJ04048, UDI-DI: 10193489195248(each), 20193489195245(case), Lot Number: 2023112290
Products Sold
DYNJ04048, UDI-DI: 10193489195248(each), 20193489195245(case), Lot Number: 2023112290
A medical device manufacturer is recalling FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048 due to 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 p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026