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

8101–8125 of 39844

HighFDA (Devices)·Z-0827-2024·2024-02-07
Custom Surgical Procedure Kits Recalled for Sterilization Assessment Failures
American Contract Systems has recalled 2,717 custom surgical procedure kits used in neurosurgery nationwide. Components were added without proper assessment of their suitability for the sterilization process.
Product
Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit n
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0951-2024·2024-02-07
Philips Ingenia 3.0T CX MRI: Loose Coil Seal May Cause Sharp Edges
Philips is recalling Ingenia 3.0T CX MRI machines due to potential failure of the Quadrature Body Coil seal adhesive. Loose seals may create sharp edges that risk skin injury or hair entanglement during scanning.
Product
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0970-2024·2024-02-07
Vortex Surgical ACTU8 Forceps Recalled Due to Residue on Forceps Tips
Vortex Surgical has voluntarily recalled 800 ACTU8 FORCEPS units due to residue identified on forceps tips. The recall affects surgical instruments distributed in the US (OH, WA, MN, MI, IA) and Korea.
Product
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0937-2024·2024-02-07
EZDilate Fixed Wire Balloon Recalled for Device Failure and Foreign Body Risk
Olympus recalls approximately 5,031 EZDilate Fixed Wire Balloons due to device bursting, leaking, and foreign body incidents during esophageal dilation procedures. Patients should contact their healthcare provider if they received this device.
Product
EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0916-2024·2024-02-07
Knee replacement tibial insert recalled due to material oxidation risk
Howmedica Osteonics Corp. is recalling DURATION knee replacement tibial inserts manufactured with raw materials over 5 years old that have developed oxidation. Oxidation can degrade the material's structural properties, affecting implant performance.
Product
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
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-0954-2024·2024-02-07
MRI Machine Coil Seal Adhesive May Create Sharp Edges
The Intera Achieva 1.5T Pulsar MRI machine's Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients. All units of this model are affected.
Product
Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0861-2024·2024-02-07
Azurion 7 M20 Imaging System Recalled for Loss of Arm and Table Movement
Philips Azurion 7 M20 FlexArm systems may lose connectivity due to a date/time software issue, preventing arm and table movement. The defect affects 108 systems worldwide, including 14 in the United States.
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-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-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-0965-2024·2024-02-07
Medline Blood Culture Collection Kit Recalled for Expired Bactec Component
Medline Industries recalls specific lots of blood culture collection kits because the Bactec component expiration date was not documented on the kit insert. Users who fail to check the component's expiration date inside the kit risk using an expired diagnostic component.
Product
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
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-0919-2024·2024-02-07
Knee Replacement Implants Recalled for Potential Material Oxidation
Howmedica Osteonics Corp. is recalling knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material has potential for elevated oxidation levels, which could affect the implant's material properties.
Product
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0908-2024·2024-02-07
Knee Replacement Inserts Recalled Due to Material Oxidation Risk
Howmedica Osteonics is recalling knee replacement inserts manufactured with UHMWPE material over 5 years old, which may develop elevated oxidation levels that could affect joint stability.
Product
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0903-2024·2024-02-07
Howmedica Osteonics Trident Knee Insert Recalled for Oxidation Risk
Howmedica Osteonics Trident knee replacement inserts manufactured with raw material over 5 years old may have elevated oxidation levels affecting material properties. This FDA Class II recall applies to Lot Number 29518001.
Product
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0953-2024·2024-02-07
MRI Scanner Quadrature Coil Seal Failure Poses Patient Contact Risk
Philips is recalling the Intera 1.5T Achieva Nova-Dual MRI scanner due to potential failure of the Quadrature Body Coil seal adhesive. If the seal fails, sharp edges may contact patients, risking skin injuries.
Product
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0945-2024·2024-02-07
Philips Achieva MRI Scanner Recall: Loose Coil Seals May Cause Skin Injury
Philips is recalling Achieva 1.5T MRI scanners due to a seal adhesive defect on the body coil that may fail during scanning, creating sharp edges that risk skin injury including abrasions and lacerations.
Product
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0899-2024·2024-02-07
Knee Replacement Component Recalled Due to Material Oxidation Risk
Howmedica Osteonics is recalling Scorpio NRG Tibial Brg Insert Assembly knee replacement components due to potential oxidation of raw materials over 5 years of age, which could affect material properties.
Product
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
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-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-0876-2024·2024-02-07
Knee Implant Inserts Recalled Due to Potential Material Degradation
Howmedica Osteonics is recalling SCORPIO TS TIB knee implant inserts (Part Number 72-4-0510) manufactured with UHMWPE material over 5 years old. The material may have elevated oxidation levels that could affect implant performance.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
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-0822-2024·2024-02-07
Custom Surgical Procedure Kits Recalled for Improper Sterilization Assessment
American Contract Systems is recalling 3,196 custom surgical procedure kits because sterilized components lacked documented suitability assessment. The components may have lost functionality or accumulated excessive sterilization residuals.
Product
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit numbe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0896-2024·2024-02-07
SCORPIO U-DOME PATELLA Knee Implants Affected by Material Oxidation Risk
Certain SCORPIO U-DOME PATELLA knee replacement devices may experience material degradation due to aged raw material. The manufacturer is recalling affected units because material oxidation could compromise device durability and performance.
Product
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
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

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8101–8125 of 39844