2021 Biologics Recalls

Date Notification	Brand Name	Product Description	Reason/Problem	Company
August 18, 2021	Urgent Voluntary Recall: Level 1 Fast Flow Fluid Warming System, NORMOFLO Fluid Warmer and Level 1 Normothermic I.V. Fluid Administration Set	Level 1® Fluid Warmer Model Numbers: H-1000, H-500 Level 1® Fluid Warming System Model Numbers: H-1028, H-1200 NORMOFLO® Fluid Warmer Model Number: H-1025 Level 1® Normothermic I.V. Fluid Administration Set Model Numbers: D-100, D-300, D-50, D-60HL, D-70, DI-100, DI-300, DI-50, DI-60HL, DI-70	Smiths Medical ASD Inc., the manufacturer of record for Level 1® Fast Flow Fluid Warming System, NORMOFLO® Fluid Warmer and Level 1® Normothermic I.V. Fluid Administration Set, is voluntarily recalling certain models of these devices.	Smiths Medical ASD Inc. Minneapolis, MN
June 2, 2021	Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) - Lot Number: NMDS210011	Product Numbers- VBM9901, VBM9905, VBM9910 and Lot Number- NMDS210011	Aziyo Biologics, Inc., (“Aziyo”) is the manufacturer of record for FiberCel Fiber Viable Bone Matrix (“FiberCel”) and is voluntarily recalling one Lot of the FiberCel product out of an abundance of caution following a customer complaint that initially reported post-surgical infections for Tuberculosis.	Aziyo Biologics, Inc., Richmond, CA