FDAAugust 6, 2021device
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
What to do
FDA enforcement status: Ongoing
Brands named
smiths medical asdsmithssmiths medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAGSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90.2026-05-29
- FDAPhilips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Elev...2026-05-18
- FDAPhilips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # ...2026-05-18
- FDAMerlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software2026-05-12
- FDABicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;2026-05-12
- FDALidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.2026-05-12
- FDABrand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a...2026-05-11
- FDABrand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membra...2026-05-11
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