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

3576–3600 of 13526

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-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-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-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-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-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-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-1277-2025·2025-03-26
Smiths Medical ProPort venous access port may separate due to defect
Smiths Medical is recalling ProPort Plastic Venous Access Ports. The plastic port housing and port reservoir may separate due to a manufacturing defect. The recall affects 3 units distributed worldwide.
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-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-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
HighFDA (Devices)·Z-1383-2025·2025-03-26
Microstream CO2 Sampling Line May Not Disconnect From Intubation Tube
Microstream intubated CO2 sampling lines may be difficult or impossible to disconnect from endotracheal tubes. This could delay necessary procedures and cause unintended extubation, potentially leading to respiratory failure.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1382-2025·2025-03-26
Microstream Neonatal-Infant CO2 Filter Line May Be Difficult to Disconnect
Microstream Neonatal-Infant Intubated CO2 Filter Lines may become difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially delaying treatment and causing unintended extubation.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVIIH
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1406-2025·2025-03-26
Cranial Surgery Procedure Kit Recalled Over Sterility Assurance Failure
American Contract Systems Inc is recalling 91 CRANI PACK cranial procedure kits because a critical component cannot be confirmed to meet sterility requirements, making them unsuitable for surgical use.
Product
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1405-2025·2025-03-26
CAPNOCHECK Airway Adapter May Break Off, Risking Ventilation Loss
CAPNOCHECK BCI Airway Adapters may break off when a valve or tube is attached, causing airway circuit disconnection and loss of ventilation. This could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
Product
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1404-2025·2025-03-26
CAPNOCHECK BCI Airway Adapter may break off, causing ventilation failure
The CAPNOCHECK BCI Airway Adapter (Model BSR) may break when attached to a valve or tube, risking airway circuit failure and loss of ventilation. Approximately 175,994 units were recalled nationwide.
Product
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1380-2025·2025-03-26
CO2 Sampling Line Adapter May Be Difficult to Disconnect; Risk of Respiratory Failure
Microstream CO2 sampling line and airway adapter may be difficult or impossible to disconnect during procedures, potentially causing treatment delays and respiratory complications including hypoxia.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1358-2025·2025-03-26
Vascular Pack Sterilization Assurance Requirements Cannot Be Confirmed
American Contract Systems cannot confirm Major Vascular Pack surgical kits were properly sterilized. Sterilization assurance failure could result in loss of functionality and delayed patient treatment.
Product
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1355-2025·2025-03-26
Neuro IR Tray recalled over unconfirmed sterilization assurance
American Contract Systems Inc is recalling Neuro IR Tray (Model WENI56J) due to inability to confirm sterilization assurance. Loss of functionality could delay or prolong treatment.
Product
NEURO IR TRAY , Model No WENI56J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1339-2025·2025-03-26
Open Heart Surgery Kit Sterilization Assurance Cannot Be Confirmed
American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient treatment.
Product
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1332-2025·2025-03-26
DR DIULUS Injection Pack Models Recalled for Sterilization Assurance Issues
American Contract Systems Inc is recalling 1,200 DR DIULUS Injection Pack kits because the manufacturer cannot confirm sterilization assurance requirements were met. This may result in loss of functionality and treatment delays.
Product
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1346-2025·2025-03-26
CYSTO Model SACY80R Recall for Sterilization Assurance Failure
American Contract Systems Inc is recalling 144 CYSTO Model SACY80R kits due to inability to confirm sterilization requirements were met. Unsterilized devices may lose functionality and delay patient treatment.
Product
CYSTO , Model No SACY80R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1393-2025·2025-03-26
Medline C-Section Procedure Kits Recalled for Defective Syringes
Medline is recalling 456 C-section procedure kits containing plastic syringes affected by an FDA safety alert. The syringes may leak or break, posing a risk to patient health during surgical procedures.
Product
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1367-2025·2025-03-26
Medline Proxima Sterile Surgical Drapes Recalled for Packaging Breach Risk
Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential packaging breach that could compromise sterility. The recall affects 16 units distributed nationwide.
Product
Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1347-2025·2025-03-26
Hip Prosthesis Pack Recalled Due to Sterilization Assurance Concerns
American Contract Systems Inc is recalling TOTAL HIP PACK models SMTH06O and SMTH06P due to inability to confirm sterilization requirements were met. Unsterilized devices could malfunction and delay patient treatment.
Product
TOTAL HIP PACK , Model No SMTH06O SMTH06P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1351-2025·2025-03-26
EAR PACK Medical Device Recalled Over Unconfirmed Sterilization
American Contract Systems Inc is recalling 51 kits of the EAR PACK Model SFEA12A because the manufacturer could not confirm sterilization requirements were met, which could cause device malfunction and delayed treatment.
Product
EAR PACK , Model No SFEA12A
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

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3576–3600 of 13526