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Open, Classified

Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A

FDA Recall Z-3209-2026 · Posted 2026-09-16

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2026-07-31
Product Quantity60

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.

Firm Action

Firm began notifying customers on July 31, 2026 via email and first-class mail. Customers were instructed to discard any affected sterile convenience kits.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K213481Medline General Surgery TrayMedline Industries, Inc. · 2022-05-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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