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

7376–7400 of 13652

HighFDA (Devices)·Z-0825-2024·2024-02-07
Surgical Procedure Kits Recalled Due to Improper Sterilization
American Contract Systems is recalling 7,881 surgical procedure kits nationwide because components were sterilized without proper validation, risking loss of functionality or elevated chemical residue.
Product
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0821-2024·2024-02-07
Gastroenterological and Urological Procedure Kits Recalled for Sterilization Process Failures
American Contract Systems is recalling AHN BIOPSY STERILE procedure kits nationwide because several components were improperly sterilized, potentially compromising device functionality and drug efficacy.
Product
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0889-2024·2024-02-07
Total Knee Replacement Component Recalled Due to Oxidation Risk
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee replacement components from specific manufacturing batches due to potential oxidation in raw materials over 5 years old. Oxidation can impact the material's properties.
Product
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0906-2024·2024-02-07
Knee replacement implant insert recalled due to material degradation risk
Howmedica Osteonics Corp. is recalling a knee replacement implant insert due to potential material oxidation. UHMWPE raw material over 5 years old may develop elevated oxidation levels, affecting implant properties.
Product
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0955-2024·2024-02-07
Philips MRI Coil Seal Adhesive May Fail and Create Sharp Patient Contact Surfaces
Philips has recalled certain SmartPath to dStream MRI coil components because the seal adhesive may fail, creating sharp edges that could contact patients during scanning and cause skin and tissue injuries.
Product
SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0823-2024·2024-02-07
Urological procedural kits recalled due to sterilization defects
American Contract Systems recalled 1,031 urological procedure kits nationwide due to sterilization process defects. Components may have damaged functionality, reduced drug efficacy, or elevated sterilization residuals.
Product
Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVCY20; c) URO ROBOTIC PACK, kit number LVUR44;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0878-2024·2024-02-07
Knee replacement implant recalled due to material oxidation risk
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee implants (Lot Numbers 482LM8, HH43K7) manufactured with aged UHMWPE material. The raw material is over 5 years old and may develop oxidation that could affect the implant's material properties.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0860-2024·2024-02-07
Philips Azurion 7 M20 FlexArm system recalled for software connectivity loss
Philips Medical Systems recalls the Azurion 7 M20 FlexArm system due to a software issue causing loss of connectivity between the FlexArm and Maquet Magnus Table. The recall affects 28 systems worldwide.
Product
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0901-2024·2024-02-07
Knee replacement poly insert recalled due to material oxidation risk
Howmedica Osteonics recalled TRIDENT knee replacement poly inserts (Part 620-00-28J, Lot 38059601) due to potential UHMWPE material oxidation in components over 5 years old. Oxidation may affect material properties.
Product
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0879-2024·2024-02-07
Knee Replacement Insert Recalled Due to Potential Material Oxidation
Howmedica Osteonics recalls SCORPIO TS TIB INSERT knee replacement components manufactured with UHMWPE raw material over 5 years old, which may experience elevated oxidation affecting material properties. No injuries or illnesses have been reported.
Product
SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0950-2024·2024-02-07
Philips Ingenia MRI Scanner Body Coil Seal Adhesive May Fail
Philips is recalling Ingenia 1.5T CX MRI scanners because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients. Model numbers 781262 and 781261 are affected.
Product
Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0947-2024·2024-02-07
Philips Achieva 1.5T MRI system recalled for defective coil seal
Philips is recalling the Achieva 1.5T Initial MRI system due to a defective Quadrature Body Coil seal. The adhesive may fail and create sharp edges that could cut or abrade patients during scanning.
Product
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0846-2024·2024-02-07
Cortera Spinal Fixation System screws recalled for incorrect dimensions
XTANT Medical is recalling Cortera Spinal Fixation System screws that were manufactured with incorrect dimensions. Screws labeled 8.5 mm by 50 mm are actually 5.5 mm by 45 mm, potentially preventing proper screw engagement.
Product
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0820-2024·2024-02-07
Custom Ear, Nose and Throat Surgical Kits Recalled Due to Sterilization Validation Failure
American Contract Systems is recalling 804 custom ear, nose and throat surgical kits nationwide because components were sterilized without validation that they could tolerate the process, potentially affecting functionality or drug efficacy.
Product
Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA41F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0924-2024·2024-02-07
Knee Replacement Insert May Degrade from Oxidized Raw Material
Howmedica Osteonics is recalling PS LIPPED TIBIAL INSERT ASSY DURACON knee replacement inserts manufactured with UHMWPE raw material over 5 years old. The aged material may develop elevated oxidation that could impact material properties.
Product
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0910-2024·2024-02-07
Knee Replacement Implant Components Recalled for Material Degradation Risk
Howmedica Osteonics Corp. is recalling specific lots of knee replacement implant components manufactured with aged raw material. The UHMWPE material may experience oxidation that could affect its structural properties.
Product
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0923-2024·2024-02-07
Knee Replacement Component Recalled for Potential Material Oxidation
Howmedica Osteonics is recalling PS Lipped Tibial Insert Assy knee replacement components manufactured with UHMWPE material older than 5 years due to potential oxidation affecting performance.
Product
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0913-2024·2024-02-07
Knee Replacement Device Recalled Due to Potential Material Oxidation
Howmedica Osteonics Corp. is recalling certain knee replacement devices (product number 6637-0-931, lot 57403601) because raw material used in manufacturing may be over 5 years old, potentially causing elevated oxidation that affects device durability.
Product
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0893-2024·2024-02-07
Knee Replacement Component Recalled for Potential Material Degradation
Howmedica Osteonics Corp. recalls SCORPIO U-DOME PATELLA knee replacement components due to potential oxidation in raw materials over 5 years old, which could affect material properties.
Product
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0952-2024·2024-02-07
Philips MRI Scanner Quadrature Coil Seal Adhesive May Fail and Create Sharp Edges
Philips Intera 1.5T Achieva Nova MRI machines (Model 781172) may develop seal adhesive failure in the Quadrature Body Coil, creating sharp edges that could injure patients during scanning.
Product
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0881-2024·2024-02-07
SCORPIO TS Knee Implant Recall Due to Material Oxidation Risk
Howmedica is recalling SCORPIO TS knee implants made with raw material over 5 years old due to potential oxidation that could degrade the device's mechanical properties.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0917-2024·2024-02-07
Knee Replacement Tibial Inserts Recalled Due to Material Oxidation Risk
Knee replacement tibial inserts from Howmedica may have elevated oxidation if manufactured with raw material over 5 years old, potentially affecting material properties.
Product
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0835-2024·2024-02-07
Philips Azurion X-ray System Software Issue Causes Restart and Imaging Loss
Philips Azurion interventional x-ray systems may continuously restart due to a software issue, causing loss of imaging functionality and data. If this occurs during a procedure, the procedure may be delayed or aborted.
Product
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0946-2024·2024-02-07
Achieva 1.5T MRI Coil Seal Adhesive May Fail Creating Sharp Edges
Philips Achieva 1.5T MRI scanner components may experience coil seal adhesive failure, creating sharp edges that could injure patients. Affected devices have been distributed worldwide.
Product
Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0934-2024·2024-02-07
Olympus EZDilate Balloons Recalled for Bursting, Leaking, and Retrieval Failure
Olympus is recalling EZDilate Fixed Wire Balloons used for esophageal dilation due to reports of bursting, leaking, and difficulty retrieving the device. The recall affects 1,796 units distributed nationwide and internationally.
Product
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
Category
Medical Device
Distribution
Distributed nationwide

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7376–7400 of 13652