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

7401–7425 of 13652

HighFDA (Devices)·Z-0943-2024·2024-02-07
Olympus EZDilate Balloon Dilators Recalled for Device Malfunction and Retained Foreign Bodies
Olympus recalled EZDilate Wire Guided Balloon endoscopic dilators due to reports of bursting, leaking, and retained foreign bodies during patient procedures. The Class II recall affects 4,182 units used to treat esophageal strictures.
Product
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0926-2024·2024-02-07
Tibial Knee Replacement Implants Recalled Due to Material Oxidation
Howmedica Osteonics is recalling tibial bearing inserts used in knee replacements manufactured from UHMWPE raw material over 5 years old. The material may develop elevated oxidation levels that could impact its structural properties.
Product
TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0911-2024·2024-02-07
Knee replacement implant recalled due to material oxidation risk
Howmedica is recalling knee replacement implants manufactured with UHMWPE material over 5 years old due to potential oxidation that could affect material properties.
Product
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0873-2024·2024-02-07
Series II Tibial Bear Insert Recalled for Potential Material Degradation
Howmedica Osteonics Corp. is recalling the Series II Tibial Bear Insert for knee replacement because UHMWPE material over 5 years old may develop elevated oxidation that can affect the component's material properties.
Product
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0922-2024·2024-02-07
Knee replacement implant recalled for potential material oxidation risk
Howmedica Osteonics is recalling the DUR PCA MTK REV INS RT knee replacement implant manufactured with UHMWPE material over 5 years old. The material can develop elevated oxidation levels that may degrade its properties.
Product
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
Category
Medical Device
Distribution
Distributed nationwide
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
HighFDA (Devices)·Z-0925-2024·2024-02-07
PS Lipped Tibial Insert Assy Duracon Knee Implant Oxidation Risk
Howmedica Osteonics is recalling PS Lipped Tibial Insert knee replacement components manufactured with aged UHMWPE material that may develop oxidation, potentially affecting device properties and performance.
Product
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0892-2024·2024-02-07
Knee Replacement Component Recalled Due to Potential Material Degradation
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patellas manufactured with raw material over 5 years old, which may have elevated oxidation levels affecting material properties.
Product
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910
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-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-0830-2024·2024-02-07
Surgical kits for childbirth recalled for sterilization and functionality risks
American Contract Systems is recalling C-section surgical kits that were sterilized without proper assessment. Components may have lost function or drug efficacy, or have excess sterilization residuals.
Product
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e) C-SECTION
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-0819-2024·2024-02-07
Cardiac central line insertion kits lack documented sterilization validation
American Contract Systems is recalling 290 cardiac procedural kits nationwide because components were subjected to sterilization without documented assessment of temperature suitability, potentially causing loss of functionality or efficacy.
Product
Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Insertion, kit number UIPL77K
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-0845-2024·2024-02-07
Surgical sutures recalled due to substandard gamma sterilization doses
Covidien is recalling multiple surgical suture products because certain lots were sterilized with gamma doses exceeding approved levels. The excess radiation may reduce suture strength over time, potentially causing wound failure and bleeding.
Product
Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0
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-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-0891-2024·2024-02-07
Knee Replacement Implant Component Recalled for Material Degradation Risk
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patella components due to potential oxidation in raw materials over 5 years old. No illnesses have been reported.
Product
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
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-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-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-0829-2024·2024-02-07
Obstetrical Labor and Delivery Kits Recalled for Potential Functionality Loss
American Contract Systems has recalled Labor and Delivery Packs because certain components may have lost functionality or efficacy due to unvalidated sterilization exposure.
Product
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0843-2024·2024-02-07
FX SHOULDER Centered Glenosphere with Screw may contain eccentric component
FX SHOULDER is recalling 4 units of a shoulder glenosphere implant component due to potential manufacturing defects that may result in eccentric product orientation rather than the intended centered design.
Product
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
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-0886-2024·2024-02-07
Knee Replacement Component Recalled Due to Raw Material Oxidation Risk
Howmedica Osteonics Corp. is recalling a SCORPIO TOTAL KNEE prosthesis component because UHMWPE raw material over 5 years old may have elevated oxidation levels affecting material properties and implant performance. Consumers with this implant should contact their physician for guidance.
Product
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
Category
Medical Device
Distribution
Distributed nationwide

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