September 23, 2026 FDA Class II Medical Devices

Bayer Medical Care, Inc.: MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;

Bayer Medical Care, Inc. · Affected quantity: 27800 kits (556 boxes)

Hazard
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.

Details
Distribution: US Nationwide distribution.. Recall #Z-3147-2026, initiated 20260731. Voluntary: Firm initiated.

Products affected
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;

Recall status
Ongoing

Reference: FDA Z-3147-2026 · Issued September 23, 2026 · Class II · Indexed by RecallSweep from the official FDA feed.

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