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Recalls & Safety · page 19

Recalls and safety alerts from the FDA, newest first.

FDA Enforcement · Jul 1, 2026

Drug recall: Perampanel CIII Tablets, 6mg

Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets. — SUN PHARMACEUTICAL INDUSTRIES INC · Class II · Ongoing · 3,456 30-count bottles

FDA Enforcement · Jul 1, 2026

Device recall: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail…

Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infec… — Dexcom, Inc. · Class II · Ongoing · N/A

FDA Enforcement · Jul 1, 2026

Device recall: VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition. — Ventec Life Systems, Inc. · Class II · Ongoing · 1

FDA Enforcement · Jul 1, 2026

Device recall: Octopus Evolution AS Tissue Stabilizer, Model TS2500

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. — Medtronic Perfusion Systems · Class II · Ongoing · 288 units

FDA Enforcement · Jul 1, 2026

Device recall: INZONE DETACHMENT SYSTEM, REF: M00345100950

Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique. — Stryker Neurovascular · Class II · Ongoing · 44,937

FDA Enforcement · Jul 1, 2026

Device recall: Da Vinci ASSY, PSS, SP1098, Part Number: 380601

Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient… — Intuitive Surgical, Inc. · Class II · Ongoing · 454

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