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 the agency’s own highest classification or reported deaths or serious injuries, 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

11401–11425 of 27470

HighFDA (Devices)·Z-1961-2021·2021-07-07
Edwards TruWave Pressure Monitoring Set: Potential Tubing Detachment
Edwards Lifesciences is recalling a pressure monitoring set due to potential detachment of the pressure tubing from the blood sampling system. The recall affects 290 units distributed across multiple US states and international locations.
Product
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-1968-2021·2021-07-07
SNS Disposable Urethral Catheter Electrode Recalled for Sterilization Process Deviations
Spes Medica is recalling SNS Disposable Urethral Catheter Electrodes due to possible deviations in the ethylene oxide sterilization process. The recalled units may not be adequately sterilized, posing a potential infection risk to users.
Product
SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE006
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1997-2021·2021-07-07
Tempus Pro Patient Monitor Software Error Risk When Unplugged
Remote Diagnostic Technologies is recalling Tempus Pro patient monitors (Trizeps 7 variant) that can produce error states when unplugged while connected to a specified laryngoscope device. No injuries have been reported.
Product
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1900-2021·2021-07-07
CT Systems Recall: Improperly Loaded Software May Increase X-Ray Radiation
GE Healthcare is recalling Revolution EVO, Optima CT660, and Optima CT680 CT Systems due to improperly loaded software that may result in additional X-ray radiation exposure to patients.
Product
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1985-2021·2021-07-07
Monitor Bracket Assembly Wear May Cause Fall Hazard for Medical Imaging Equipment
Philips medical imaging equipment monitor bracket assemblies may detach due to unrecognized shaft wear, risking the monitor falling and causing serious injury to patients, operators, or bystanders.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1994-2021·2021-07-07
Bard PowerPICC Catheter Kits Recalled for Wrong Guidewire Size
Bard Access Systems is recalling PowerPICC catheter convenience kits with incorrect guidewires. Kits labeled as containing 70 cm guidewires actually contain 50 cm guidewires, which could affect proper catheter placement.
Product
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1986-2021·2021-07-07
Philips CT Monitor Bracket Assemblies Recalled for Detachment Risk
Philips has recalled 1,301 Monitor Bracket Assemblies for CT systems worldwide due to shaft wear that could cause monitors to detach and fall, potentially injuring patients, operators, or service personnel.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1995-2021·2021-07-07
Carefusion Recalls MaxPlus Bi Fuse Extension Sets for Leakage Defect
Carefusion is recalling a batch of MaxPlus Bi Fuse extension sets due to leakage defects. The affected units failed validation testing for leakage and were inadvertently released to the Tennessee market.
Product
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1928-2021·2021-07-07
Quidel Lyra SARS-CoV-2 Assay Kits Recalled for Potential False Negatives
Quidel Corporation is recalling approximately 29,787 kits of the Lyra SARS-CoV-2 Assay due to a theoretical risk that samples with very high viral loads could produce false negative results. No false negatives have been formally reported.
Product
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1989-2021·2021-07-07
Philips Medical Monitor Bracket May Detach from Ceiling Mount
Philips medical imaging monitors with worn bracket assembly shafts may detach from ceiling suspensions and fall on patients, operators, or staff. No injuries have been reported.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1970-2021·2021-07-07
SNS Disposable Urethral Catheter Electrode Recalled for Sterilization Process Deviations
Spes Medica has recalled SNS Disposable Urethral Catheter Electrodes due to possible deviations in ethylene oxide sterilization processes. The recall affects one lot distributed in California, Massachusetts, and South Carolina.
Product
SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE002
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1963-2021·2021-07-07
Edwards VAMP Jr. blood management system pressure tubing may detach
Edwards Lifesciences is recalling 1,679 units of Edwards VAMP Jr. 6 in blood management systems (lot 63445142, 63630816) due to potential pressure tubing detachment.
Product
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-1981-2021·2021-07-07
Monitor bracket assembly recalled for detachment hazard on CT imaging systems
Philips is recalling 1,301 monitor bracket assemblies for CT/PET-CT imaging systems due to shaft wear that could cause detachment from the suspension arm, potentially resulting in the monitor falling and serious injury.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1966-2021·2021-07-07
Edwards TruWave Pressure Monitoring Set Recalled Due to Tubing Detachment Risk
Edwards Lifesciences is recalling Edwards TruWave (3 cc)/VAMP Jr Pressure Monitoring Sets (Lot 63545959) due to a potential risk that pressure tubing may detach from the blood sampling system.
Product
Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-1991-2021·2021-07-07
PowerPICC Catheter Kits Recalled for Incorrect Micro-Introducer Components
Bard Access Systems is recalling 180 units of 5Fr PowerPICC Catheter kits because they contain incorrect micro-introducers.
Product
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1980-2021·2021-07-07
Philips Continuous CT Fluoroscopy Monitor Bracket Assembly Fall Risk
Philips is recalling 1,301 Monitor Bracket Assemblies due to shaft wear that could cause the assembly to detach from the ceiling suspension arm. This could result in the monitor falling and causing serious injury to patients, operators, bystanders, or service personnel.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1863-2021·2021-06-30
Nitric Oxide Delivery System Dosing Deficiency During Console Transitions
GENOSYL DS Nitric Oxide Delivery System is recalled for delivering below-intended doses during transitions between primary and backup consoles following a software update.
Product
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1934-2021·2021-06-30
Dexcom G6 Sensor 3-Pack Recalled for Temperature-Related Measurement Errors
Cardinal Health is recalling 2,357 kits of Dexcom G6 Sensor 3-Pack due to temperature exposure during shipping that may cause inaccurate glucose readings. Affected units were distributed in Florida, Georgia, and South Carolina.
Product
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1930-2021·2021-06-30
FREESTYLE LIBRE 14 DAY glucose monitoring system recalled for temperature exposure
Cardinal Health is recalling 8,959 glucose monitoring kits due to temperature exposure during shipping that may result in inaccurate readings. Affected devices were distributed nationwide.
Product
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1931-2021·2021-06-30
FreeStyle Libre 2 Glucose Monitoring System Recalled for Inaccurate Results
Cardinal Health is recalling FreeStyle Libre 2 glucose monitoring systems shipped between February and March 2021 due to temperature exposure during shipment that may cause inaccurate readings.
Product
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1905-2021·2021-06-30
SARS-CoV-2 IgG II reagent may produce falsely elevated results in certain software versions
This diagnostic reagent may multiply test results by 1000x in certain software versions, leading to falsely elevated readings. The Class II recall affects 13,337 units distributed in the US and internationally.
Product
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-1944-2021·2021-06-30
FilmArray Pneumonia Panel diagnostic test kits recalled for false results
BioFire Diagnostics is recalling 9 FilmArray Pneumonia Panel test kits due to manufacturing defects causing false positive and negative test results, as well as control failures.
Product
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1939-2021·2021-06-30
OneTouch Delica Lancets Recalled Due to Temperature Exposure During Shipping
Cardinal Health is recalling OneTouch Delica Lancets (100-count boxes) after devices were exposed to freezing temperatures during shipping, which may affect blood glucose test accuracy. No injuries have been reported.
Product
ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1946-2021·2021-06-30
Medical Action Curved Hemostats recalled due to flaking metal risk
Medical Action Industries is recalling curved hemostats distributed across 16 U.S. states due to a manufacturing defect causing potential metal flaking and discoloration.
Product
Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1904-2021·2021-06-30
Philips Allura Xper System power supplies may fail unexpectedly
Certain low-voltage power supplies in Philips Allura Xper interventional X-ray systems may fail, potentially causing loss of imaging functionality. 42 devices are affected worldwide.
Product
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Category
Medical Device
Distribution
10 states

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11401–11425 of 27470