FDA Medical devices recall ·
FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048 recall
- Recall number
- Z-0922-2026
- Date
- (initiated November 13, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 53 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
Why was it recalled?
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.
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
DYNJ04048, UDI-DI: 10193489195248(each), 20193489195245(case), Lot Number: 2023112290
Distribution
US Nationwide distribution in the states CA, CO, IL, KS, and MI.
States: California Colorado Illinois Kansas Michigan
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-0922-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.