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-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-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-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-1988-2021·2021-07-07
Philips Monitor Bracket Assembly falls due to shaft wear in medical imaging systems
Philips monitor bracket assemblies for CT/PET imaging systems may detach due to shaft wear, posing a risk of the monitor falling and causing serious injury to patients, operators, or bystanders.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1996-2021·2021-07-07
Infusion Pump Order Form Discontinued Due to Ambiguous Reuse Instructions
Flowonix Medical is recalling physician order forms for Prometra infusion pumps due to ambiguous wording that could be misinterpreted as instructions to reuse previously extracted medication, posing an infection risk.
Product
Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Model GTIN-14 11827 Prometra Programmable 20mL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1959-2021·2021-07-07
Edwards TruWave Pressure Monitoring Set Recalled for Potential Tubing Detachment
Edwards Lifesciences is recalling its pressure monitoring set due to potential tubing detachment. Approximately 460 units distributed across North America and Europe are affected.
Product
Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507
Category
Medical Device
Distribution
33 states
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-1971-2021·2021-07-07
Tripolar Hooked Stimulation Probes recalled for ethylene oxide sterilization deviation
Spes Medica is recalling Tripolar Hooked Stimulation Probes due to possible deviations in the ethylene oxide sterilization process. The affected devices were distributed to healthcare facilities in California, Massachusetts, and South Carolina.
Product
Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1990-2021·2021-07-07
Monitor Bracket Assembly Shaft Wear Risk in Philips CT Fluoroscopy Systems
Philips CT fluoroscopy monitor brackets may detach from suspension arms 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 728306 - Brilliance iCT 728311 - Brilliance iCT SP
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-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-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-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-1969-2021·2021-07-07
Dragonfly Laryngeal Electrode Recalled Due to Sterilization Process Issues
Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes due to possible deviations in ethylene oxide sterilization parameters. The affected lots are LS20E2538I and 110320C, distributed to select US states.
Product
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1965-2021·2021-07-07
Pressure monitoring set recalled for potential pressure tubing detachment
Edwards Lifesciences is recalling the TruWave 3 cc/VAMP Jr pressure monitoring set (Lot #63598812) due to a potential risk that the pressure tubing may detach from the blood sampling system.
Product
Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
Category
Medical Device
Distribution
33 states
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-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-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-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-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-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-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-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-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-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

How to read this listing

Filters

13501–13525 of 13802