Deroyal Industries, Inc. Lafollette: Medical Device Recall in 2021 - (Recall #: Z-2499-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set

Product Classification:

Class I

Date Initiated: September 2, 2021

Date Posted: October 6, 2021

Recall Number: Z-2499-2021

Event ID: 88660

Reason for Recall:

DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids.

Status: Terminated

Product Quantity: 2880 units

Code Information:

1) CYSTO PACK PGYBK / 89-5721.03 Lot 46459298 exp 10/01/2021 Lot 47042849 exp 11/01/2021 Lot 47217717 exp 01/01/2022 Lot 47461066 exp 04/10/2022 Lot 47525103 exp 04/01/2022 Lot 47696113 exp 05/01/2022 Lot 48210787 exp 07/01/2022 Lot 49049665 exp 10/01/2022 Lot 47525103 exp 04/01/2022 Lot 49101769 exp 07/01/2022 Lot 49215918 exp 11/01/2022 Lot 49291064 exp 11/1/2022 Lot 49351178 exp 01/01/2023 Lot 49455989 exp 01/01/2023 Lot 49683631 exp 01/01/2023 Lot 50920251 exp 03/01/2023 Lot 51081699 exp 08/01/2023 Lot 51253374 exp 08/01/2023 Lot 52004222 exp 10/01/2023 Lot 52658453 exp 02/01/2024 Lot 53216841 exp 02/01/2024 Lot 53666480 exp 09/01/2024 Lot 54367035 exp 01/01/2025 2) GU TUR BASIN SET PGYBK / 89-6425.07 Lot 52173376 exp 10/1/2021 Lot 52902866 exp 12/01/2021 Lot 53216518 exp 12/01/2021 Lot 53331541 exp 12/01/2021 Lot 53411946 exp 03/01/2022 Lot 53598712 exp 02/01/2022 Lot 53784881 exp 09/01/2022 Lot 53888656 exp 03/01/2022 Lot 53964621 exp 03/01/2022 Lot 54009801 exp 08/01/2022 Lot 54246494 exp 09/01/2022

Distribution Pattern:

US distribution in Florida and South Carolina.

Voluntary or Mandated:

Voluntary: Firm initiated