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

11426–11450 of 13748

ModerateFDA (Devices)·Z-1386-2022·2022-07-27
Stryker Trevo Trak 21 Microcatheter recalled for missing carton product illustration
Stryker Neurovascular is recalling 71 Trevo Trak 21 Microcatheter units because the product carton label is missing the required product drawing or illustration.
Product
Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X37+TRAK21 2-PACK - CE, REF: 91415; TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, REF:
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1422-2022·2022-07-27
Laboratory Reagent Recalled Due to Inaccurate Calibration Curves
Randox Laboratories is recalling Soluble Transferrin Receptor reagent (TF10159) due to calibration curve defects causing inaccurate test results on Siemens Atellica CH analyzers.
Product
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1423-2022·2022-07-27
Soluble Transferrin Receptor Calibrator Recall Due to Lab Errors
Randox Laboratories is recalling Soluble Transferrin Receptors Calibrator kits used in lab analyzers. The calibrators can produce incorrect test results, with some values potentially underestimated by up to 30 percent.
Product
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1392-2022·2022-07-27
GreenLight HPSEA Laser Fiber Recall Due to Card Incompatibility Error
Boston Scientific is recalling GreenLight HPSEA Laser Fibers due to an incompatibility with the fiber card that causes an error message and requires equipment replacement during procedures.
Product
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1404-2022·2022-07-27
X80 RADiant Photoelectric Therapy System Compatibility Issue
Xstrahl Limited is recalling specific lot codes of the X80 RADiant Photoelectric Therapy System due to a potential compatibility issue with replacement treatment applicators. Devices were distributed in Florida, California, and Kentucky.
Product
X80 RADiant Photoelectric Therapy System
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1394-2022·2022-07-27
Triton Sponge System Software Instructions Updated for Proper Sponge Handling
Stryker is updating the Instructions for Use for the Triton Sponge System software (versions 4.6.5, 4.8.7, 4.9.6) to clarify proper handling technique for sponges and calibration placard. The FDA Class III recall affects 51 units distributed nationwide.
Product
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1451-2022·2022-07-27
LumiraDx SARS-CoV-2 Antibody Quality Control Recalled Due to Unauthorized Modification
LumiraDx is recalling SARS-CoV-2 antibody quality control products because modifications to the test were made outside the scope of FDA-approved authorization. The recall affects 99 units distributed across 13 U.S. states.
Product
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Category
Medical Device
Distribution
13 states
LowFDA (Devices)·Z-1393-2022·2022-07-27
NeuRx Diaphragm Pacing System Labeling Revised for Storage Clarity
Synapse Biomedical revised labeling for the NeuRx Diaphragm Pacing System to clarify that temperature range symbols indicate storage conditions, not transport or package conditions. The revision affects 71 units distributed in the United States.
Product
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing S
Category
Medical Device
Distribution
19 states
LowFDA (Devices)·Z-1390-2022·2022-07-27
Erythropoietin Control Product Instructions Contain Incorrect CE Marking
R & D Systems is replacing Instructions for Use (IFU) for Quantikine IVD Erythropoietin Human Serum Controls due to an incorrect CE marking designation that should not appear on the self-certified product.
Product
Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1349-2022·2022-07-20
CoolCurve+ Vacuum Applicator Recalled for Increased Paradoxical Hyperplasia Reports
Zeltiq Aesthetics is voluntarily recalling CoolCurve+ ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia during 2019–2021, an adverse event involving abnormal fat growth at treatment sites.
Product
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-1360-2022·2022-07-20
Isopure IsoMix PRO Mixing System Electrical Short Recall
Isopure is recalling approximately 119 units of the Sodium Bicarbonate Mixing and Distribution System due to an electrical short causing a thermal event and device damage. No injuries reported.
Product
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-1377-2022·2022-07-20
Modular Orthopedic Implant Screws May Not Loosen During Surgery
FDA recalls certain Endo Model orthopedic implants because the blind screws may not loosen during surgery, potentially requiring surgeons to change their approach and prolonging the procedure.
Product
Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1353-2022·2022-07-20
MiniMed 630G Insulin Pump Recalled for Battery Cap Deterioration
Medtronic MiniMed is recalling the MiniMed 630G insulin pump due to battery cap deterioration that may cause loss of power and function. Approximately 126,558 units distributed in the U.S. and Canada are affected.
Product
MiniMed 630G Insulin Pump (U.S. and Canada Version)
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1355-2022·2022-07-20
MiniMed 670G Insulin Pump Battery Cap Defect Causing Power Loss
MiniMed 670G Insulin Pump may lose power due to battery cap deterioration, affecting approximately 279,251 units distributed in the U.S. and overseas.
Product
MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1378-2022·2022-07-20
Modular orthopedic prosthesis recall due to intraoperative component locking
Waldemar Link is recalling Endo Model Modular Femur and Tibia orthopedic prostheses because the blind screws on the tibial component cannot be loosened during surgery, potentially prolonging procedures.
Product
Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1325-2022·2022-07-20
Philips ProxiDiagnost N90 radiography system: firmware issue causes incorrect radiation dose
Philips is recalling 140 ProxiDiagnost N90 radiography systems due to a firmware issue in the Wallstand VS2 component. After system restart or first exposure with Wallstand VS2, the system may deliver incorrect radiation doses and misposition anatomic markers.
Product
ProxiDiagnost N90. radiography and fluoroscopy system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1346-2022·2022-07-20
CoolMax ZELTIQ Vacuum Applicator recalled for paradoxical hyperplasia complaints
Zeltiq Aesthetics is voluntarily discontinuing 2,945 CoolMax ZELTIQ Vacuum Applicators due to an increase in paradoxical hyperplasia complaints between 2019 and 2021, an adverse event causing unwanted tissue growth instead of intended fat reduction.
Product
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-1368-2022·2022-07-20
Dental bonding primer may lack resin component affecting restoration
Ultradent Peak Universal Bond self-etch dental primers may be missing resin, potentially compromising bond strength. Affected products were distributed nationwide and internationally.
Product
Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1326-2022·2022-07-20
Radiography System Firmware Error May Cause Incorrect Radiation Dose
Philips DigitalDiagnost 4 radiography systems may deliver incorrect radiation doses due to a Wallstand VS2 firmware issue causing incorrect image orientation and misaligned anatomical markers.
Product
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1365-2022·2022-07-20
Neonatal Transport System Oxygen Supply Component Pressure-Rating Defect
Draeger Medical is recalling neonatal transport systems because an oxygen supply component is not rated for the system's working pressure. This affects 38 units distributed internationally but not in the United States.
Product
Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1362-2022·2022-07-20
Pressure Monitoring Sets with Excess Coating Pose Embolism Risk
Cook Incorporated is recalling approximately 11,451 Pressure Monitoring Sets because excess coating material on the needle component may enter the bloodstream, potentially causing pulmonary embolism or ischemia.
Product
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1380-2022·2022-07-20
Tibial Prosthetic Component Recall: Blind Screws Cannot Be Loosened Intraoperatively
Tibial prosthetic components have defective blind screws that may not loosen during surgery, requiring procedure changes. Approximately 3,785 units of models W 16-2817/32, 35, and 37 were distributed across the US and internationally.
Product
Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1327-2022·2022-07-20
Radiography System Firmware Flaw May Cause Incorrect Image Orientation and Dose
Philips DigitalDiagnost 4 Flex/Value radiography systems have a firmware issue in the Wallstand VS2 board that may cause incorrect image orientation and radiation dosing. The defect affects 140 systems distributed nationwide.
Product
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1356-2022·2022-07-20
MiniMed 720G Insulin Pump Recalled Due to Battery Cap Deterioration Risk
Medtronic MiniMed is recalling approximately 575 MiniMed 720G Insulin Pumps due to battery cap deterioration that may result in power loss and device malfunction.
Product
MiniMed 720G Insulin Pump (O.U.S. Version)
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1354-2022·2022-07-20
MiniMed 640G Insulin Pumps Recalled for Battery Cap Deterioration
Medtronic has recalled approximately 323,417 MiniMed 640G insulin pumps due to battery cap deterioration that may cause loss of power and functionality. Patients should contact Medtronic or their healthcare provider immediately.
Product
MiniMed 640G Insulin Pump (O.U.S. Version)
Category
Medical Device
Distribution
53 states

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11426–11450 of 13748