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

13551–13575 of 13837

HighFDA (Devices)·Z-1983-2021·2021-07-07
CT Monitor Bracket Assembly Recalled Due to Shaft Wear and Detachment Risk
Philips North America is recalling CT system monitor bracket assemblies due to shaft wear that could cause the bracket to detach from the suspension arm, potentially allowing the monitor to fall and cause serious injury.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore
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-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-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-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-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-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-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-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-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-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-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-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 lo
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-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
ModerateFDA (Devices)·Z-1967-2021·2021-07-07
Dragonfly Laryngeal Surface Electrode recalled for sterilization process deviation
Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes due to possible deviations in ethylene oxide sterilization process. Affected lot LS20G3274I was distributed in California, Massachusetts, and South Carolina.
Product
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1960-2021·2021-07-07
Edwards TruWave Pressure Monitoring Set Tubing Detachment Recall
Edwards Lifesciences is recalling Edwards TruWave pressure monitoring sets due to potential tubing detachment from the blood sampling system. No illnesses or injuries have been reported.
Product
Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489
Category
Medical Device
Distribution
33 states
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-1937-2021·2021-06-30
OneTouch Ultrasoft Lancets recalled due to temperature exposure during shipping
Cardinal Health is recalling 531 boxes of OneTouch Ultrasoft Lancets shipped February-March 2021 due to temperature exposure during shipment that may cause inaccurate test results.
Product
ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1918-2021·2021-06-30
Hays Ultrasound Kit Recalled for Missing FDA Clearance
Exact Medical Manufacturing recalls 10,020 units of Hays Ultrasound Kit (H1000SE) due to lack of FDA 510(k) clearance for use in body openings. The recall affects units in FL, MT, NY, OH, GA, and Puerto Rico.
Product
Hays Ultrasound kit Item ID: H1000SE
Category
Medical Device
Distribution
5 states
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-1936-2021·2021-06-30
OneTouch Ultra Blue test strips recalled for temperature exposure damage
Cardinal Health is recalling 5,356 boxes of OneTouch Ultra Blue test strips after units were exposed to freezing temperatures during shipping, which may cause inaccurate glucose readings.
Product
ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1921-2021·2021-06-30
Ultrasonic Transducer Probe Covers Recalled for Missing FDA Clearance
Exact Medical Manufacturing is recalling 33,250 ultrasonic transducer probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings, distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Product
Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
Category
Medical Device
Distribution
5 states

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13551–13575 of 13837