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

6251–6275 of 27393

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-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-0920-2024·2024-02-07
Knee replacement devices recalled due to potential material degradation
Howmedica Osteonics Corp. recalls knee replacement devices with UHMWPE components manufactured from raw material over 5 years old due to potential oxidation that may affect material properties.
Product
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0888-2024·2024-02-07
Knee Replacement Implant Recalled Due to Material Oxidation Risk
Howmedica Osteonics recalled Scorpio Total Knee prosthetics with UHMWPE components produced from raw material over 5 years old, which may develop elevated oxidation and affect implant properties.
Product
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710
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-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-0865-2024·2024-02-07
GE Voluson IC9-RS Ultrasound Probes Recalled for Double Image Artifacts
GE HealthCare is recalling certain IC9-RS intracavitary ultrasound probes due to a double image artifact that creates ghost images. This unrecognized artifact can lead to diagnostic errors.
Product
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Category
Medical Device
Distribution
0 states
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-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-0844-2024·2024-02-07
Surgilon Braided Nylon Sutures Recalled for Excessive Gamma Sterilization
Covidien LP recalls specific lots of Surgilon Braided Nylon sutures sterilized with excessive gamma radiation, which may weaken the sutures and cause wound complications.
Product
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
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-0816-2024·2024-02-07
Custom Anesthesia Kits Recalled Over Sterilization Validation Failure
American Contract Systems recalls 182 anesthesia procedure kits due to improper sterilization assessment of added components. The kits may have compromised functionality, reduced drug efficacy, or elevated sterilant residue.
Product
Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L
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-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-0870-2024·2024-02-07
Knee implant component recalled due to potential material oxidation
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee implant components made from UHMWPE material over 5 years old that may develop elevated oxidation.
Product
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0887-2024·2024-02-07
Knee Replacement Implant Recalled Due to Potential Material Degradation
Knee replacement components recalled due to potential oxidation in UHMWPE material that could affect durability. Approximately 76 units distributed in the US with additional international distribution.
Product
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510
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-0936-2024·2024-02-07
EZDilate Endoscopic Balloon Devices Recalled for Malfunction and Foreign Body Risk
Olympus is recalling EZDilate Fixed Wire Balloon devices used for esophageal stricture treatment due to reports of inflation/deflation failures, bursting, leaking, and foreign body retention in patients.
Product
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
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-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-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-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-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-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-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

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6251–6275 of 27393