Medline Industries, LP recalls Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Convenience kits MYRINGOTOMY PACK-LFDYNJ59097AUDI-DI 10198459046551Affected lot25FBU754
What the firm is doing
Firm began notifying customers on July 31, 2026 via email and first-class mail. Customers were instructed to discard any affected sterile convenience kits.
DistributionShow detailsHide
US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3209-2026
- FDA 510(k) clearance · K213481The device's official FDA premarket clearance record
- FDA device classification · LROOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4370The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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