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 5027

SevereFDA (Devices)·Z-1493-2025·2025-04-09
VentStar Flex 220 Breathing Circuit Recalled for Potential Hose Cracks
Draeger, Inc. is recalling 65,150 units of the VentStar Flex 220 breathing circuit due to the potential for cracks to form in the hose. A crack could affect gas delivery during anesthesia or ventilation procedures.
Product
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1499-2025·2025-04-09
Anesthesia Circuit Kit Flex EPA recalled due to breathing hose cracking
Draeger is recalling the Anesthesia Circuit Kit Flex EPA due to the potential for cracks to form in the breathing circuit hose. Approximately 13,620 units have been distributed domestically and internationally. Users should discontinue use of affected units immediately.
Product
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intend
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1498-2025·2025-04-09
Anesthesia Circuit Kit Flex (P)2 recalled for potential breathing hose cracks
Draeger, Inc. is recalling the Anesthesia Circuit Kit Flex (P)2 due to the potential for cracks to form in the breathing circuit hose. This FDA Class I recall affects approximately 9,250 units distributed domestically and internationally.
Product
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is inten
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1497-2025·2025-04-09
Anesthesia Circuit Kit Flex 6 Recalled for Potential Breathing Hose Cracks
Draeger, Inc. is recalling the Anesthesia Circuit Kit Flex 6 (Model MP02744) due to potential cracks forming in the breathing circuit hose. Approximately 293,660 units were distributed nationwide and internationally.
Product
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1494-2025·2025-04-09
Draeger ID Circuit Flex 220 breathing circuit hoses subject to cracking
Draeger's ID Circuit Flex 220 breathing circuit for anesthesia machines may develop cracks in the hose. The recall affects 3,325 units distributed nationwide and internationally.
Product
Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1495-2025·2025-04-09
Draeger Anesthesia Circuit Kit Flex 1 recalled for potential hose cracks
Draeger, Inc. is recalling Anesthesia Circuit Kit Flex 1 devices nationwide and internationally due to potential cracks in the breathing circuit hose that conducts anesthesia gases.
Product
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1496-2025·2025-04-09
Anesthesia Circuit Kit Flex 2 recalled due to breathing hose crack risk
Draeger's Anesthesia Circuit Kit Flex 2 is recalled because of the potential for cracks to form in the breathing circuit hose. No injuries have been reported.
Product
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1390-2025·2025-04-02
Shiley Adult Tracheostomy Tubes Recalled Due to Flange Disconnection Risk
Covidien is recalling 780 Shiley Adult Flexible Tracheostomy Tubes because the flange may disconnect from the outer cannula, potentially causing respiratory failure, aspiration, or death.
Product
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1396-2025·2025-04-02
CVAC Aspiration System Requires Labeling Update for Pressure Risk
The CVAC Aspiration System requires a labeling update to add safety instructions for high-viscosity kidney fluid. Continuing fluid inflow without adequate outflow can create dangerous intrarenal pressure imbalances.
Product
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-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-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-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-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
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-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-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-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
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-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
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

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701–725 of 5027