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

7426–7450 of 13683

HighFDA (Devices)·Z-0833-2024·2024-02-07
Orthopedic surgical kits recalled for unassessed external component sterilization
American Contract Systems recalls 5,524 orthopedic surgical kits due to unassessed sterilization of external components that may lose functionality, drug efficacy, or have excess sterilization chemical residue.
Product
Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0894-2024·2024-02-07
SCORPIO U-Dome Patella Knee Implant Recalled Due to Material Degradation Risk
Howmedica Osteonics has recalled certain SCORPIO U-Dome Patella knee implants due to potential material oxidation in units manufactured with raw material over 5 years old. The oxidation may affect the implant's material properties.
Product
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0914-2024·2024-02-07
Knee Replacement Inserts Recalled Due to Potential Material Degradation
Howmedica Osteonics is recalling PRIMARY REV.TIB.INSERT-DURACON knee replacement inserts manufactured with aging UHMWPE material that has potential for oxidation affecting material properties. Affected lots: 36273601 and 36609701.
Product
PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0818-2024·2024-02-07
Cardiac surgical kits recalled due to improper sterilization exposure
American Contract Systems is recalling 12,291 cardiac procedure kits nationwide. Components were exposed to sterilization without documented assessment of suitability, potentially causing loss of functionality or efficacy.
Product
Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0912-2024·2024-02-07
Knee Replacement Implant Recalled Due to Potential Material Oxidation Risk
Howmedica Osteonics Corp. is recalling certain knee replacement implants made with UHMWPE material over 5 years old that may have oxidized, potentially affecting implant performance.
Product
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
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-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-0817-2024·2024-02-07
Custom Cardiac Procedural Kits Recalled for Inadequate Sterilization Assessment
American Contract Systems is recalling 4394 custom cardiac procedural kits due to components added without proper assessment for sterilization exposure, which may result in loss of functionality or drug efficacy.
Product
Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, ki
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0884-2024·2024-02-07
Knee replacement bearing insert recalled due to material degradation risk
Howmedica Osteonics Corp. is recalling Scorpio-Flex knee bearing inserts made with material over 5 years old that may develop oxidation affecting performance. Affected patients should contact their physician if they experience knee problems.
Product
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
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-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-0882-2024·2024-02-07
SCORPIO TS TIB INSERT Knee Replacement Components Recalled for Potential Material Degradation
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement inserts manufactured with aging raw material. The material may develop elevated oxidation that could affect performance.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0880-2024·2024-02-07
Knee Replacement Implant Recalled for Potential Material Degradation Risk
Howmedica Osteonics Corp. is recalling SCORPIO TS TIB knee replacement implants manufactured with aged raw material that may develop oxidation, potentially affecting performance.
Product
SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518
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-0932-2024·2024-02-07
Volar Bearing Plate wrist fixation systems recalled for bearing dislodgement
TriMed Inc. recalls Volar Bearing Plate wrist fixation systems because bearings may dislodge from distal peg holes during implantation, potentially compromising fracture fixation. Approximately 270 units distributed in five states.
Product
Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures,
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0963-2024·2024-02-07
Medline Adult Blood Culture Kits Recalled Due to Unlabeled Component Expiration Dates
Medline is recalling specific Adult Blood Culture Kits because the expiration date of an internal Bactec component is not reflected on the kit insert, creating a risk of using an expired component.
Product
MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0866-2024·2024-02-07
Surgical needle holders distributed with incorrect product labels
Aesculap Inc is recalling 53 JACOBSON DUROGRIP TC micro needle holders that were shipped with incorrect product labels, which may cause delays during surgical procedures.
Product
MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0966-2024·2024-02-07
Medline Blood Culture Collection Kit Recalled for Undocumented Component Expiration
Medline is recalling blood culture collection kits because the Bactec component expiration date is not documented on the kit insert. Users who do not check the component directly risk using an expired element.
Product
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0969-2024·2024-02-07
Medline Blood Culture Tray Adult recalled for incomplete component labeling
Medline recalls Adult Blood Culture Trays due to incomplete documentation of Bactec component expiration dates on kit inserts. Users should verify the component expiration date before use.
Product
MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0964-2024·2024-02-07
Blood Culture Bottle Kit Recalled for Expired Component Documentation Issue
Medline is recalling blood culture bottle kits with mismatched component expiration date documentation, creating risk of using expired components if not verified by users.
Product
MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0837-2024·2024-02-07
FDA Recalls Terragene Bionova PCD Device Due to Instructions Discrepancy
Terragene S.A. is recalling Terragene Bionova PCD (Model PCD222-C) medical devices nationwide due to a discrepancy between FDA-cleared instructions for use and the actual instructions distributed with the products.
Product
Terragene Bionova PCD (PCD222-C)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0868-2024·2024-02-07
TERUMO HydroPearl embolization microspheres recalled for manufacturing process deviation
MICROVENTION is recalling TERUMO HydroPearl Compressible Microspheres because manufacturing and quality processes were not followed during production. The recall affects 22 units distributed in seven U.S. states.
Product
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0968-2024·2024-02-07
Medline Blood Culture Kits recalled for inaccurate expiration dating
Medline recalls Blood Culture Kits because kit inserts fail to reflect the expiration date of included Bactec components. Users could unknowingly use expired components if they don't independently check the Bactec label.
Product
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0782-2024·2024-01-31
Hologic PANTHER FUSION System Recalled for Potential False Positive Flu B Results
Hologic is recalling PANTHER FUSION nucleic acid testing systems due to the potential for false positive influenza B test results when a sample is also positive for SARS-CoV-2.
Product
PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0815-2024·2024-01-31
FDA Recalls DiaSorin HSV-2 Antibody Test Lots Due to False Positive Results
DiaSorin LIAISON HSV-2 Type Specific IgG test kits are being recalled because specific lots may produce false positive or equivocal results. Affected kits were distributed in the US and Canada.
Product
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Category
Medical Device
Distribution
Distributed nationwide

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7426–7450 of 13683