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 13717

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-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-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-1383-2022·2022-07-20
Aesculap Micro Needleholder Recalled for Incorrect Size Labeling
Aesculap Implant Systems LLC is recalling TC Cooely Micro Needleholder instruments because units labeled as 200mm are actually 150mm. This labeling error could impact surgical procedures.
Product
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1359-2022·2022-07-20
MiniMed 780G Insulin Pump battery cap deterioration may cause power loss
Medtronic MiniMed is recalling 83,398 MiniMed 780G insulin pumps distributed throughout the United States due to battery cap deterioration that may cause power loss and device malfunction.
Product
MiniMed 780G 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
HighFDA (Devices)·Z-1373-2022·2022-07-20
Alcon Custom Pak Surgical Procedure Packs recalled for incorrect latex gloves
Alcon has recalled 320 kits of Custom Pak Surgical Procedure Packs distributed across Arizona, California, Missouri, and New York because they contain latex gloves instead of the specified non-latex gloves, creating an allergen hazard for sensitive patients.
Product
Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11
Category
Medical Device
Distribution
4 states
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-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-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-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-1366-2022·2022-07-20
Wright EVOLVE TRIAD Plate Cutter fails sterilization requirements under double-wrap configuration
Wright Medical recalls 231 EVOLVE TRIAD Plate Cutters due to sterilization failure when double-wrapped. The devices cannot be adequately sterilized, creating infection risk during surgical procedures.
Product
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1372-2022·2022-07-20
Blood gas test device recalled for inaccurate oxygen measurements
Siemens epoc BGEM Test Cards may produce inaccurate blood oxygen measurements, potentially leading to misdiagnosis and unnecessary respiratory treatment. The recall affects 263 boxes distributed across multiple states.
Product
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
Category
Medical Device
Distribution
10 states
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-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-1364-2022·2022-07-20
AquaBplus Water Purification System installation guideline error reduces disinfection
AquaBplus 2000 water purification systems for dialysis have an installation guideline error that may reduce heat disinfection effectiveness. Patients using affected units may be at risk.
Product
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US)
Category
Medical Device
Distribution
Distributed nationwide
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-1367-2022·2022-07-20
Anti-SARS-CoV-2 IgG Reagent: Stability Time Overstated in Instructions
Ortho-Clinical Diagnostics is recalling Anti-SARS-CoV-2 IgG Quantitative Reagent Pack because the Instructions For Use incorrectly state on-analyzer stability of 8 weeks when the actual supported time is 6 weeks.
Product
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
Category
Medical Device
Distribution
Distributed nationwide
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-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-1358-2022·2022-07-20
MiniMed 770G Insulin Pump Battery Cap May Deteriorate, Causing Power Loss
Medtronic is recalling MiniMed 770G insulin pumps because battery cap deterioration may cause power loss and insulin delivery failure. Approximately 123,585 units are affected.
Product
MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
Category
Medical Device
Distribution
53 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-1329-2022·2022-07-20
Radiography system firmware defect causes incorrect radiation dose
Philips DigitalDiagnost C90 radiography systems have a firmware defect that may cause incorrect radiation doses and anatomic marker misalignment. The issue affects 140 systems nationwide with specific serial numbers.
Product
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
Category
Medical Device
Distribution
Distributed nationwide

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11426–11450 of 13717