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

12026–12050 of 13816

HighFDA (Devices)·Z-0874-2022·2022-04-13
Philips Allura and Azurion X-ray systems may display incorrect previous images
Philips Allura and Azurion X-ray systems running StentBoost Live R2.0 may display images from previous scans or other patients due to a software defect. 338 units are affected and globally distributed.
Product
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0884-2022·2022-04-13
Alinity m HBV AMP Kit Recalled for Risk of Falsely High Test Results
Abbott Molecular is recalling the Alinity m HBV AMP Kit due to potential for falsely high results on negative samples. The kits are used for Hepatitis B virus testing in the US and internationally.
Product
Alinity m HBV AMP Kit (US and CE)
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0737-2022·2022-04-13
Philips StentBoost Live imaging system acquisition malfunction recall
Philips Healthcare is recalling the StentBoost Live R2.0 application due to a software configuration error. The imaging system fails to stop image acquisition automatically, continuing indefinitely while the pedal is pressed instead of stopping after 40 images.
Product
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0875-2022·2022-04-13
Vena Cava Filter Sets Recalled for Instruction for Use Documentation Updates
Cook Medical recalled 24,641 Gunther Tulip Vena Cava Filter Sets due to updates required in the Instruction for Use documentation covering device description, indications, contraindications, warnings, and precautions.
Product
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0888-2022·2022-04-13
Brius Pontics Orthodontic Devices Recalled for Incomplete Design Validation
Brius Technologies recalls Brius Pontics custom orthodontic devices that were sold before completing required design control procedures and documentation.
Product
Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0730-2022·2022-04-13
X-ray system displays incorrect collimation area information
The YSIO X.Pree x-ray system's user interface displays incorrect collimation information during image acquisition. While actual collimation functions correctly, the display does not match preset parameters, potentially confusing operators.
Product
YSIO X.Pree
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0889-2022·2022-04-13
Brius Patient Specific Brackets recalled without completing design control process
Brius Technologies is recalling Brius Patient Specific Brackets that were sold before the company completed the required design control process and regulatory documentation.
Product
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0856-2022·2022-04-13
Oral gel recalled for failed microbial testing
SA3, LLC is recalling Silatrix Oral Gel Polymerized Sucralfate Gel due to failed microbial testing. Consumers should not use the product and contact their healthcare provider or SA3, LLC.
Product
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0895-2022·2022-04-13
Abbott Amplatzer Steerable Delivery Sheath instructions for use updated
Abbott is recalling 529 units of the Amplatzer Steerable Delivery Sheath (Class II) distributed outside the US due to an update to the device's instructions for use.
Product
Amplatzer Steerable Delivery Sheath
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0876-2022·2022-04-13
Cook Celect Platinum Vena Cava Filter Set Instructions Recall
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets due to revisions needed in the instructions for use, including updates to contraindications, warnings, precautions, and potential adverse events.
Product
Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0850-2022·2022-04-06
Medical software recall: RayStation radiation therapy dose calculation errors
RayStation and RayPlan radiation therapy planning software may calculate incorrect radiation doses due to a source-to-skin distance calculation error. The FDA Class II recall affects 149 units distributed in the US.
Product
RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35), RayStation 5 Service Pack 3 (5.0.3.17), RayStation 6/RayPlan 2 (6.0.0.24), RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2), RayS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0849-2022·2022-04-06
Radiation therapy planning software: incorrect dose density calculation
RayStation/RayPlan radiation therapy software (versions 4–11A) may incorrectly calculate radiation dose density in treatment planning. The error affects dose calculations in regions partially covered by certain structures.
Product
RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0848-2022·2022-04-06
Radiation therapy planning software subject to jaw positioning errors during optimization
RayStation radiation therapy planning software (versions 6-11A) may unexpectedly change jaw positions during optimization after dose or target modifications. Users should verify treatment plans carefully before delivery.
Product
TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0852-2022·2022-04-06
Hanger-Bar 2P 45cm Recalled for Fall Hazard from Loosened Set Screw
Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm because the set screw may loosen due to a manufacturing defect, creating a fall hazard.
Product
Hanger-Bar 2P 45cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0851-2022·2022-04-06
Hanger-Bar 2P Medical Device Recalled for Loosening Set Screw
Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm due to a manufacturing defect allowing the set screw to loosen, creating a fall hazard.
Product
Hanger-Bar 2P 45cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0855-2022·2022-04-06
Medtronic MiniMed insulin pumps may not deliver basal insulin without configuration
Medtronic MiniMed insulin pumps may be used without programmed basal rates, causing insulin under-delivery and potentially severe high blood sugar. Patients must configure and save basal settings before use, but labeling doesn't clearly explain this requirement.
Product
MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 620G (OUS Only): MMT-1750; MiniMed 640G (OUS O
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-0830-2022·2022-04-06
Siemens Magnesium Flex reagent cartridge recalled for imprecision and assay errors
Siemens recalls magnesium reagent cartridges due to imprecision and abnormal assay flags that may cause erroneous diagnostic results and require repeat patient testing.
Product
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0853-2022·2022-04-06
Surgical Drill System Instrument Pack Recalled Over Device Breakage Risk
Wright Medical is recalling 176 packs of the EasyFuse Dynamic Compression System Instrument Pack due to risk that the drill guide can jam and break during surgery.
Product
EasyFuse Dynamic Compression System Instrument Pack
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0834-2022·2022-04-06
FORE-SIGHT ELITE Tissue Oximeter: Inaccurate Oxygen Saturation Readings
Edwards Lifesciences FORE-SIGHT ELITE Absolute Tissue Oximeter (Model 01-06-3000) is recalled because StO2 (tissue oxygen saturation) values may read inaccurately low when used with the large sensor on arms or legs, potentially leading to inappropriate treatment.
Product
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0847-2022·2022-04-06
BALLARD Multi-Access Port Catheter Recalled for Incorrect Expiration Date
Avanos Medical is recalling 2,520 BALLARD Multi-Access Port Catheters due to incorrect expiration dates on the packaging. No illnesses or injuries have been reported. Patients should verify the lot number and contact their healthcare provider.
Product
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0843-2022·2022-04-06
Hip prosthetic femoral head component size and offset labeling mismatch
Howmedica Osteonics is recalling 40 units of Biolox delta Ceramic V40 Femoral Head components where the size and/or offset may not match package labeling.
Product
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0827-2022·2022-04-06
Hand Pendant Malfunction in Proton Therapy Systems Poses Patient Injury Risk
Mevion S250 and S250i Proton Therapy Systems hand pendants may malfunction, causing unintended motion of the therapy couch and nozzle. This poses a risk of patient injury if they contact moving equipment.
Product
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0835-2022·2022-04-06
Tissue oximeter module may provide inaccurately low oxygen readings
Edwards Lifesciences is recalling 8,389 FORE-SIGHT ELITE Tissue Oximeter modules that may display inaccurately low oxygen saturation values when used in certain body locations, potentially leading to inappropriate treatment decisions.
Product
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0842-2022·2022-04-06
Ceramic Hip Femoral Head Component May Not Match Package Label
Howmedica Osteonics is recalling certain Biolox delta Ceramic V40 Femoral Head components because the actual size and offset may not match the package label. Patients with these implants should contact their surgeon.
Product
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0836-2022·2022-04-06
Revogene diagnostic device recalled for photomultiplier tube malfunction
Meridian Bioscience is recalling Revogene diagnostic devices due to compromised photomultiplier tubes that may produce false-positive or indeterminate test results.
Product
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840
Category
Medical Device
Distribution
Distributed nationwide

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12026–12050 of 13816