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Open, Classified

Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648F; 6) DIEP FLAP, REF DYNJ66867A; 7) KIT FREE FLAP MOSES, REF DYNJ905366A; 8) FREE FLAP, REF DYNJ905634B; 9) ROBOTIC THORACIC, REF DYNJ907817; 10) TRANSPHENOIDAL, REF DYNJ908165; 11) METREX, REF DYNJ910072; 12) DIEP FLAP, REF DYNJ910120A.

FDA Recall Z-0783-2025 · Posted 2024-12-30

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeFDE
Date Initiated2024-11-21
Product Quantity943 units

Reason for Recall

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

Firm Action

Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of UAE, and Canada.

Official Source

View FDA Recall →

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

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