Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

701–725 of 5100

SevereFDA (Drugs)·D-0301-2025·2025-04-02
SinuCleanse Neti Pot Nasal Wash System Recalled for Bacterial Contamination
Ascent Consumer Products Inc. is recalling SinuCleanse Soft Tip Neti Pot Nasal Wash System due to bacterial contamination with Staphylococcus aureus. Consumers should stop using this product immediately.
Product
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1277-2025·2025-03-26
Smiths Medical ProPort Plastic Venous Access System Recalled
Smiths Medical is recalling the ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and reservoir to separate.
Product
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1287-2025·2025-03-26
Smiths Medical ProPort Venous Ports Recalled for Potential Housing Separation
Smiths Medical is recalling ProPort Low Profile Plastic Venous Access Systems because the plastic port housing and reservoir may separate due to a manufacturing defect. Approximately 8,515 units worldwide are affected.
Product
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1288-2025·2025-03-26
Smiths Medical ProPort Implantable Port Plastic Housing May Separate
The ProPort Low Profile Plastic Venous Access System is being recalled because the port housing and port reservoir may separate due to a manufacturing defect, affecting approximately 2,236 units distributed worldwide.
Product
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1280-2025·2025-03-26
Smiths Medical ProPort Implantable Port Housing May Separate Due to Manufacturing Defect
Smiths Medical is recalling 9,506 ProPort implantable venous access ports due to a manufacturing defect that may cause the port housing and reservoir to separate. No injuries have been reported.
Product
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1281-2025·2025-03-26
Smiths Medical ProPort Implantable Port Risk of Component Separation
Smiths Medical is recalling its ProPort Plastic Implantable Ports due to a manufacturing defect that may cause the port housing and reservoir to separate, potentially compromising device function.
Product
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1282-2025·2025-03-26
Smiths Medical ProPort Plastic Venous Access System recalled for port separation defect
Smiths Medical is recalling its ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and reservoir to separate, affecting 1,695 units distributed worldwide.
Product
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1284-2025·2025-03-26
Smiths Medical ProPort Venous Access System Recalled for Port Separation Risk
Smiths Medical is recalling ProPort Plastic Venous Access Systems due to a manufacturing defect that can cause the port housing and reservoir to separate. This may result in device failure affecting patients worldwide.
Product
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1278-2025·2025-03-26
Smiths Medical ProPort Implantable Venous Ports Recalled for Separation Defect
Smiths Medical has recalled 643 ProPort Plastic implantable venous access ports that may separate due to a manufacturing defect. The recall affects units distributed worldwide.
Product
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1285-2025·2025-03-26
Smiths Medical ProPort Plastic Venous Access System Recalled for Port Housing Separation Risk
Smiths Medical is recalling certain ProPort Plastic Venous Access System devices due to a manufacturing defect that may cause the port housing and reservoir to separate.
Product
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1279-2025·2025-03-26
Smiths Medical ProPort Implantable Port Component Separation Due to Manufacturing Defect
Smiths Medical is recalling ProPort Plastic implantable port systems because the plastic port housing and port reservoir may separate due to a manufacturing defect. The recall affects 2,311 units distributed worldwide.
Product
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1286-2025·2025-03-26
Smiths Medical ProPort Implantable Port May Separate Due to Manufacturing Defect
Smiths Medical is recalling ProPort Plastic Venous Access Ports because the port housing and reservoir may separate due to a manufacturing defect. Contact your physician if you have an affected device.
Product
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1283-2025·2025-03-26
Smiths Medical ProPort Plastic Implantable Ports Recalled for Port Housing Separation
Smiths Medical is recalling 1961 units of ProPort Plastic Implantable Ports worldwide due to a manufacturing defect that may cause the port housing and reservoir to separate. This Class I recall affects patients dependent on venous access systems.
Product
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1289-2025·2025-03-19
Portex Endotracheal Tubes may deliver inadequate ventilation due to smaller diameter
Portex Endotracheal Tubes from Smiths Medical ASD, Inc. may have a smaller diameter than expected, potentially causing inadequate ventilation and patient hypoxia.
Product
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1306-2025·2025-03-19
Aortic Root Cannula Recall for Loose Male Luer Component
Medtronic is recalling 316,205 aortic root cannulas due to unexpected loose material in the male luer connector. If not identified before use, this defect could cause stroke; if identified, it may delay surgery.
Product
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, m
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1304-2025·2025-03-19
BD Alaris Systems Manager Infusion Software Affected by Programming Request Issue
BD Alaris Systems Manager software may transmit outdated automated programming requests to progressive care units. The FDA has classified this as a Class I recall.
Product
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Category
Medical Device
Distribution
21 states
SevereFDA (Devices)·Z-1305-2025·2025-03-19
BD Care Coordination Engine Software May Send Outdated Programming Requests
BD Care Coordination Engine infusion software may send outdated automated programming requests to care units. Healthcare facilities in affected US states should review their systems.
Product
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
Category
Medical Device
Distribution
21 states
CriticalFDA (Devices)·Z-1244-2025·2025-03-12
Rotarex Atherectomy Catheter Recalled for Helix Fracture Risk
Bard is recalling Rotarex Atherectomy System catheters due to potential helix fracture or breakage that could cause vessel injury and severe bleeding. Updated instructions are being distributed to clarify procedural steps to reduce this risk.
Product
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1257-2025·2025-03-12
Insulin pump recall: Medtronic Paradigm models malfunction during airplane flight
Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.
Product
Paradigm insulin pump, REF: MMT-754
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1246-2025·2025-03-12
Medtronic Pipeline Vantage device recall: deformation may cause blood clots
The Pipeline Vantage Embolization Device may malfunction, with the braid deforming or not positioning correctly, potentially causing blood clots. Approximately 7,820 units are affected worldwide.
Product
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1253-2025·2025-03-12
Baxter Sigma Spectrum Infusion System Recalled for Missing Mounting Screws
Baxter Healthcare is recalling 66 units of Sigma Spectrum Infusion System (V6) due to potential missing motor mounting screws that may have occurred during servicing. Missing screws could affect the device's operation.
Product
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1245-2025·2025-03-12
Medtronic Pipeline Vantage Embolization Device Recall for Structural Deformation Risk
Medtronic is recalling approximately 18,245 unused Pipeline Vantage embolization devices due to incomplete wall apposition and braid deformation that may lead to thrombosis and serious adverse events.
Product
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1205-2025·2025-03-12
FDA Recalls VARIPULSE Bi-Directional Ablation Catheter Due to Neurovascular Events
Biosense Webster is recalling VARIPULSE Bi-Directional Ablation Catheters (REF D141201) due to an observed trend of neurovascular events. The FDA issued a Class I recall affecting approximately 497 units distributed worldwide.
Product
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomat
Category
Medical Device
Distribution
10 states
SevereFDA (Devices)·Z-1263-2025·2025-03-12
Insulin Pump Recalled for Abnormal Delivery During Flight Pressure Changes
Medtronic MiniMed 720G insulin pumps may malfunction during airplane travel due to air pressure changes, causing abnormal insulin doses that can lead to severe low or high blood sugar emergencies.
Product
MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1254-2025·2025-03-12
Baxter Spectrum IQ Infusion System may have missing motor mounting screws
Baxter Spectrum IQ Infusion Systems may lack motor mounting screws due to a servicing defect. The FDA Class I recall affects 323 units distributed nationwide.
Product
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

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701–725 of 5100