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

776–800 of 39760

ModerateFDA (Devices)·Z-2270-2026·2026-06-10
B. Braun UPMC double catheter trays contain Mastisol with cracking tubing
B. Braun SESK UPMC Double Catheter Trays are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering it unusable.
Product
Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Version: N/A Product Description: SESK UPMC DOUBLE CATHETER TRAY Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2267-2026·2026-06-10
B. Braun spinal epidural kits contain Mastisol with cracking tubing
B. Braun Lyndon B Johnson Hospital spinal epidural kits are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering it unusable.
Product
Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2285-2026·2026-06-10
Philips Azurion 3M15 Medical Imaging Systems Recalled Due to Software Issue
Philips Medical Systems is recalling 27 Philips Azurion 3M15 units because a software issue can cause unusable dark images during imaging procedures.
Product
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2261-2026·2026-06-10
Shiley tracheostomy tubes recalled over incorrect display box labeling
Covidien Shiley Tracheostomy Tubes with inner cannula, REF 6FEN, are being recalled following a customer complaint about incorrect display box labeling. 1,002 units are affected.
Product
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2272-2026·2026-06-10
Covidien Mon-a-Therm general purpose temperature probes lack FDA clearance
Covidien Mon-a-Therm General Purpose Temperature Probes, REF 90044, are being recalled because the devices lack FDA clearance. 1,775 units are affected.
Product
Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2268-2026·2026-06-10
B. Braun kits contain Mastisol adhesive with potentially cracking tubing
B. Braun CESK Riverside Health System kits are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering the product unusable.
Product
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Description: CESK RIVERSIDE HEALTH SYSTEM Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2265-2026·2026-06-10
B. Braun spinal epidural catheters contain Mastisol with cracking tubing
B. Braun NES1725KFXL spinal epidural closed tip catheters are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack. 1,730 units affected.
Product
Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2271-2026·2026-06-10
Covidien esophageal stethoscope temperature sensors lack FDA clearance
Covidien Mon-a-Therm Esophageal Stethoscopes with Temperature Sensor 400TM, REF 90042, are being recalled because the devices lack FDA clearance. 23,000 units are affected.
Product
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2235-2026·2026-06-03
Medline Spinal Block Kits Recalled Due to Quality and Efficacy Concerns
Medline Industries, LP is recalling Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection due to microbiology testing data integrity concerns and efficacy complaints.
Product
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2234-2026·2026-06-03
Medline Kits Containing Bupivacaine Hydrochloride Recalled Due to Quality and Efficacy Concerns
Medline Industries, LP is recalling specific Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection due to microbiology testing data integrity concerns and efficacy complaints.
Product
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit SKU DYNJRA1181C; 2) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKu DYNJRA1860.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2237-2026·2026-06-03
Medline spinal anesthesia trays recalled over Huons bupivacaine quality concerns
Medline spinal anesthesia trays containing Huons Bupivacaine HCl in Dextrose Injection are being recalled after that drug was recalled. 200,702 kits are affected.
Product
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL ANESTHESIA TRAY-LF, Medline Kit SKU DYNJRA0102A; 2) SPINAL TRAY-LF, Medline Kit SKU DYNJRA0143B; 3) SPINAL PREP TRAY-LF, Medline Kit SKU DYNJRA0205B; 4) SPINAL TRAY, Medline Ki
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2211-2026·2026-06-03
Automated Impella Controllers await four pending hardware safety updates
Automated Impella Controllers that have not been through Abiomed's servicing process are pending four hardware updates addressing motor control, startup and pump stop risks.
Product
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2238-2026·2026-06-03
Automated Impella Controllers recalled over alarm, power and purge cassette faults
Automated Impella Controllers sold outside the US are being recalled over alarm failures, power-path faults, electrical-short risks, inaccurate motor-current sensing and purge cassette misalignment.
Product
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2236-2026·2026-06-03
Medline spinal block trays recalled over Huons bupivacaine quality concerns
Medline spinal block trays containing Huons Bupivacaine HCl in Dextrose Injection are being recalled after that drug was recalled. 30,120 kits are affected.
Product
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097; 2) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1154; 3) SPINAL TRAY, Medline Kit SKU DYNJRA1192A; 4) BLOCK TRAY, Medline
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2231-2026·2026-06-03
Medline anesthesia trays recalled over Huons bupivacaine quality concerns
Medline anesthesia trays containing Huons Bupivacaine HCl in Dextrose Injection are being recalled after that drug was recalled. 1,100 kits are affected.
Product
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2232-2026·2026-06-03
Medline pain and Whitacre spinal trays recalled over bupivacaine concerns
Medline pain trays and Whitacre spinal block trays containing Huons Bupivacaine HCl in Dextrose Injection are being recalled after that drug was recalled. 28,106 kits are affected.
Product
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN TRAY, Medline Kit SKU DYNJRA1555; 2) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1817; 3) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA1920; 4) ULTRASOUND
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2160-2026·2026-06-03
RelayPro thoracic stent-graft clasp may not release from delivery system
The RelayPro Thoracic Stent-Graft System is subject to a labeling update concerning proximal clasp disconnection from the outer control tube, which may prevent release of the graft.
Product
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2233-2026·2026-06-03
Medline spinal trays recalled over Huons bupivacaine quality concerns
Medline spinal trays containing Huons Bupivacaine HCl in Dextrose Injection are being recalled after that drug was recalled over microbiology data integrity and efficacy complaints.
Product
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2246-2026·2026-06-03
GE CARESCAPE telemetry servers may lose ECG and SpO2 monitoring
GE HealthCare is recalling trade-in CARESCAPE Telemetry Servers because a persistent NO COMM or OFF NETWORK condition can cause potential loss of ECG and SpO2 monitoring.
Product
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2242-2026·2026-06-03
GE CARESCAPE v5 telemetry servers may lose patient monitoring signal
GE HealthCare is recalling CARESCAPE Telemetry Server V5 ATO models because a persistent NO COMM or OFF NETWORK condition can cause potential loss of ECG and SpO2 monitoring.
Product
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2258-2026·2026-06-03
Philips Azurion system hard drives may degrade and lose imaging
Philips Azurion interventional X-ray systems are being recalled because hard drives in the system PCs may lose performance as they age, potentially causing loss of imaging functionality.
Product
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2247-2026·2026-06-03
GE ApexPro v6.0 software may lose ECG and SpO2 monitoring
GE HealthCare ApexPro v6.0 eDelivery Software is being recalled because a persistent NO COMM or OFF NETWORK condition can cause potential loss of ECG and SpO2 monitoring.
Product
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2230-2026·2026-06-03
Halyard nitrile exam gloves failed chemical permeation performance specifications
Halyard Purezero Ultraviolet Nitrile Exam Gloves are being recalled because they failed to meet specifications for chemical permeation performance. 452,500 units are affected.
Product
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2245-2026·2026-06-03
GE CARESCAPE ARK-2250L telemetry servers may lose patient monitoring
GE HealthCare CARESCAPE Telemetry Servers ARK-2250L are being recalled because a persistent NO COMM or OFF NETWORK condition can cause potential loss of ECG and SpO2 monitoring.
Product
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2243-2026·2026-06-03
GE ApexPro disaster recovery USB kits may lose patient monitoring
GE HealthCare ApexPro v5.0 Software Disaster Recovery USB Kits are being recalled because a persistent NO COMM or OFF NETWORK condition can cause loss of ECG and SpO2 monitoring.
Product
GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Category
Medical Device
Distribution
0 states

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776–800 of 39760