FDA Medical devices recall ·
Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A recall
- Recall number
- Z-3209-2026
- Date
- (initiated July 31, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 60
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
Why was it recalled?
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
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
UDI-DI 10198459046551 Lot 25FBU754
Distribution
US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
States: Arkansas Florida Maryland North Carolina Texas
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-3209-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.