Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. Due to Leakage of FMS gravity tub sets (281113) at...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DePuy Mitek, Inc., a Johnson & Johnson Co. directly.
Affected Products
1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.
Quantity: 15,678
Why Was This Recalled?
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek, Inc., a Johnson & Johnson Co. has 51 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report