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

13501–13525 of 13802

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-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-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 - Brillia
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-1982-2021·2021-07-07
Monitor Bracket Assembly Fall Hazard Recall Affects Multiple CT Systems
Philips is recalling 1,301 monitor bracket assemblies used with CT systems due to shaft wear that could cause monitors to fall, potentially injuring 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 PET/CT systems. Brilliance 64, Brilliance 40, Ingenuity Flex 728235 - Brilliance 40 728231/728232 - Brilliance 64 728317/728318 - Ingenuity Flex
Category
Medical Device
Distribution
Distributed nationwide
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
HighFDA (Devices)·Z-1955-2021·2021-07-07
Synaptive Suction Sets Recalled for Metal Burrs on Tube Interior
Synaptive Medical is recalling 1,291 Trackable Suction Sets for visible metal burrs and filings along the inner suction tube. The defect may contaminate the surgical field or cause injury.
Product
Synaptive Trackable Suction Set Standard and Malleable
Category
Medical Device
Distribution
15 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-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-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-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-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-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-1984-2021·2021-07-07
Philips CT Monitor Bracket Assembly May Detach and Fall
Philips is recalling 1,301 monitor bracket assemblies for CT imaging systems due to shaft wear that could cause detachment and fall of the monitor. This could result in serious injury to patients, operators, and staff.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
Category
Medical Device
Distribution
Distributed nationwide
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 lo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1987-2021·2021-07-07
Philips CT Monitor Bracket May Detach Due to Shaft Wear
Philips CT fluoroscopy monitors may develop bracket shaft wear that could lead to the monitor detaching and falling while attached to cables.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1979-2021·2021-07-07
Philips CT Monitor Bracket Assembly risks ceiling fall hazard
Philips is recalling 1,301 Monitor Bracket Assemblies used in CT and PET/CT imaging systems worldwide due to potential shaft wear that could cause the monitor to detach from the ceiling mount and fall, posing injury risk.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1962-2021·2021-07-07
Blood Management System Pressure Tubing May Detach
Edwards Lifesciences blood management system (VJ0990) pressure tubing may detach from the blood sampling system during use. The recall affects 2,000 units distributed across the U.S., Canada, UK, and Italy.
Product
Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-1977-2021·2021-07-07
Exactech Humeral Augmented Tray orthopedic implant components recalled for disengagement risk
Exactech is recalling Humeral Augmented Tray (HAT) orthopedic implant components because the retaining ring may disengage during use. The recall affects 36 devices distributed in six U.S. states.
Product
Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1975-2021·2021-07-07
PERLA TL Lateral Connector Open Spinal Fusion Devices Recalled for External Label Error
SPINEART SA is recalling 44 units of PERLA TL Lateral Connector Open spinal fusion connectors distributed in the U.S. due to external labels that incorrectly list the rod size.
Product
PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1978-2021·2021-07-07
NeuMoDx Cartridge Recall: Risk of False Positive Diagnostic Results
NeuMoDx Molecular Inc. is recalling certain cartridge lots that may produce false positive diagnostic results. Affected healthcare providers should verify tests performed with these cartridges and contact the manufacturer for guidance.
Product
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1976-2021·2021-07-07
Medtronic Endurant II Stent Graft System Recalled for Incorrect Assembly
Medtronic is recalling 3 Endurant II/IIs Stent Graft Systems due to an incorrect stentstop assembly component in the delivery system. The defective devices use an 18-French assembly instead of the required 20-French component.
Product
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
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-1993-2021·2021-07-07
Percutaneous Dilation Tracheostomy Kit Recalled for Incorrect Size Labeling
One lot of PORTEX ULTRperc Percutaneous Dilation Tracheostomy Kit (Lot 4072715) was incorrectly labeled as 7.0mm when it is 9.0mm. The 40 units were distributed in Pennsylvania, Michigan, Maryland, and Florida.
Product
PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.
Category
Medical Device
Distribution
Distributed nationwide

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13501–13525 of 13802