FDAJanuary 23, 2026device
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Nu...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
What to do
FDA enforcement status: Ongoing
Brands named
i t s
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAAcumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw; 3070-27010 2.7mm x 10mm NL Hexalobe Screw; 3070-27011 2.7mm x 11mm NL Hexalobe Screw; 3070-27012 2.7mm x 12mm NL Hexalobe Screw; 3070-27013 2.7mm x 13mm NL Hexalo...2026-05-28
- FDAAdvance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-282026-05-27
- FDABrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Monitoring System2026-05-27
- FDAPhilips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A2026-05-26
- FDAPhilips Avalon Fetal Monitor, FM 30 Part numberM2703A2026-05-26
- FDAAbiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.2026-05-22
- FDAAbiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.2026-05-22
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