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

2976–3000 of 27375

HighFDA (Devices)·Z-1376-2025·2025-03-26
CO2 Sampling Lines May Fail to Disconnect During Neonatal Care
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended extubation. The defect affects neonatal and pediatric patients worldwide.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1366-2025·2025-03-26
Proxima Drape surgical drapes recalled due to potential sterility loss
Medline Industries recalls 506 units of Proxima Drape surgical drapes nationwide due to potential packaging breaches that could compromise sterility. Affected drapes were labeled as MINOR PACK or LAPAROSCOPY variants.
Product
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1384-2025·2025-03-26
Microstream CO2 Sampling Line Disconnection Failure Poses Respiratory Risk
Microstream CO2 sampling adapters may become difficult or impossible to disconnect from endotracheal tubes, potentially delaying critical procedures and causing respiratory complications.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI; Microst
Category
Medical Device
Distribution
Distributed nationwide
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-1362-2025·2025-03-26
Vein Tray Models UTVT21C Unable to Confirm Sterilization Assurance
American Contract Systems Inc is recalling certain Vein Tray models because sterilization assurance requirements could not be confirmed. The affected units may lack functionality and could lead to delayed treatment.
Product
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1379-2025·2025-03-26
CO2 Sampling and Airway Adapter Devices May Be Difficult to Disconnect
Oridion Medical's CO2 sampling and airway adapter devices may be difficult to disconnect from endotracheal tubes, potentially causing treatment delays and serious respiratory complications in neonatal, infant, and pediatric patients.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991
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-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-1357-2025·2025-03-26
General Laparoscopic Pack Recall Due to Unconfirmed Sterilization
American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.
Product
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1343-2025·2025-03-26
PICC Line Catheters Recalled for Sterilization Assurance Issues
American Contract Systems is recalling PICC line catheters because sterilization assurance requirements could not be confirmed. Unsterilized devices may lose functionality and delay patient treatment.
Product
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1365-2025·2025-03-26
Sterile Surgical Drape Recalled Due to Potential Packaging Breach
Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.
Product
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1389-2025·2025-03-26
Candida ID Antigen recalled for reduced sensitivity, potential false negatives
Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.
Product
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1399-2025·2025-03-26
VERICIS Merge Cardio may display inconsistent measurement data in clinical reports
The VERICIS Merge Cardio system may display inconsistent cardiovascular measurements in patient reports when specific workflows are used. This could affect clinical decisions based on the reported data.
Product
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1352-2025·2025-03-26
Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization
American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.
Product
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
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-1402-2025·2025-03-26
Merge Cardio Software Recalled: Measurement Inconsistency in Patient Reports
Merge Healthcare recalls Merge Cardio cardiovascular software due to measurement data inconsistency. When users manually edit or remeasure values in certain workflows, derived measurements may not match original measurements in patient reports.
Product
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.
Category
Medical Device
Distribution
0 states
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
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-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
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
HighFDA (Devices)·Z-1328-2025·2025-03-19
Stryker CinchLock anchor recalled due to pullwire breakage
Stryker is recalling its CinchLock Flex Knotless Anchor due to an increase in pullwire breakage complaints. The broken pullwire may remain in the implant body after deployment.
Product
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1298-2025·2025-03-19
GE Revolution CT and Apex systems coolant fluid leak hazard
GE Healthcare Revolution CT and Apex series imaging systems may leak blue coolant fluid near the gantry base, creating a potential slip and fall hazard. Approximately 250 units have been distributed worldwide.
Product
GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1302-2025·2025-03-19
GE Revolution CT Systems Potential Coolant Leak Slip-and-Fall Risk
GE Healthcare Revolution CT systems may leak glycol coolant near the gantry base. While the non-toxic fluid poses no chemical hazard, it creates a slip-and-fall risk if not noticed and cleaned.
Product
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1321-2025·2025-03-19
ZOLL Powerheart G5 AED devices may fail self-test in extreme environments
ZOLL is recalling Powerheart G5 AED devices that may fail their self-test when exposed to extreme temperature or humidity, potentially affecting proper device operation.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrilla
Category
Medical Device
Distribution
Distributed nationwide

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2976–3000 of 27375