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

5251–5275 of 13512

SevereFDA (Devices)·Z-2615-2024·2024-09-04
PORTEX Bivona Neonatal and Pediatric Tracheostomy Tubes Recalled for Flange Tear
Smiths Medical is recalling specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes because the securement flange may tear due to a manufacturing defect.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRAC
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2608-2024·2024-09-04
Bivona Neonatal Tracheostomy Tubes Recalled for Flange Tear Risk
Smiths Medical is recalling specific lots of Bivona Neonatal and Pediatric Tracheostomy Tubes because the securement flange may tear due to manufacturing defects.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2596-2024·2024-09-04
Bivona Neonatal, Pediatric, and Adult Tracheostomy Tubes Recalled for Flange Defect
Smiths Medical is recalling specific lots of Bivona Neonatal, Pediatric, and Adult Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, potentially compromising tube security.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FL
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2613-2024·2024-09-04
Tracheostomy Tubes Recalled for Torn Securement Flange Risk
Smiths Medical recalls PORTEX Bivona tracheostomy tubes due to a manufacturing defect that may cause the securement flange to tear, potentially leading to tube dislodgement.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2603-2024·2024-09-04
Tracheostomy Tubes Recalled for Manufacturing Defect Affecting Securement Flange
Smiths Medical recalled specific lots of PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected products were distributed worldwide.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2692-2024·2024-09-04
FreeStyle Libre 3 Sensors Recalled for Inaccurate Glucose Readings
FreeStyle Libre 3 sensors may report falsely high glucose levels, causing users to over-dose insulin and miss dangerous low blood sugar episodes. Abbott has recalled 8,174 units.
Product
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
Category
Medical Device
Distribution
12 states
SevereFDA (Devices)·Z-2588-2024·2024-09-04
Smiths Medical Bivona Tracheostomy Tubes Recalled for Flange Tear Risk
Smiths Medical is recalling PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected lots include neonatal, pediatric, and adult sizes distributed worldwide with 177,340 units impacted.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2594-2024·2024-09-04
PORTEX Bivona Tracheostomy Tubes Recalled Due to Flange Tearing Defect
PORTEX Bivona Tracheostomy Tubes (3.0mm, 3.5mm, 4.0mm) are being recalled due to a manufacturing defect that may cause the securement flange to tear. This could result in airway obstruction or loss of tube securement.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH T
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2605-2024·2024-09-04
Bivona Tracheostomy Tubes Recalled for Potential Securement Flange Failure
Smiths Medical recalled specific lots of Bivona Tracheostomy Tubes after identifying a manufacturing defect that may cause the securement flange to tear, risking tube displacement.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030; 3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE ,
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2604-2024·2024-09-04
Bivona Tracheostomy Tubes Recalled for Manufacturing Defect in Securement Flange
Smiths Medical recalls specific lots of Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes worldwide due to a manufacturing defect that may cause the securement flange to tear.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , P
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2725-2024·2024-09-04
Stryker surgical bur may overheat and cause thermal tissue damage
Stryker iBur surgical burs may overheat during use in neurosurgery and spine surgery, potentially causing thermal tissue damage requiring medical intervention. Approximately 2,507 units were distributed worldwide.
Product
Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2839-2024·2024-09-04
BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Recall
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain Sol-Millennium Medical syringes that are subject to a manufacturer recall. A total of 103 units were distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001025;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2718-2024·2024-09-04
Nanoplasty 3D Bunion Implant System Recalled for Mechanical Failure Risk
Treace Medical Concepts is recalling its Nanoplasty 3D Bunion Implant (Model SK57) nationwide due to potential mechanical failures where locking screws may strip or fail to seat properly. No injuries have been reported.
Product
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2769-2024·2024-09-04
Medline Centurion Procedure Kits Recalled for Syringe Leaks and Breakage
Medline Industries is recalling Centurion procedure kits with plastic syringes affected by an FDA Safety Alert. The syringes may leak, break, or develop quality issues that could pose risks to patient health.
Product
Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2941-2024·2024-09-04
FRT250 Telescopic Implant Cartridge Recalled for Component Substitution
OrthoPediatrics Canada is recalling FRT250 cartridges used in the Fassier-Duval Telescopic IM System because an incorrect component was substituted during assembly.
Product
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2754-2024·2024-09-04
Medline Procedural Kits with Defective Syringes Recalled Worldwide
Medline procedural kits with defective plastic syringes are recalled due to risks of leaks and breakage. The affected syringes were flagged in an FDA safety alert and may compromise patient safety during medical procedures.
Product
Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2734-2024·2024-09-04
Electrocardiograph Recall: CARDIOVIT AT-180 May Produce Signal Artifacts
Schiller is recalling CARDIOVIT AT-180 electrocardiographs due to potential high-frequency signal artifacts during ECG acquisition that may affect diagnostic accuracy. 1,084 units are affected worldwide.
Product
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2755-2024·2024-09-04
Medline Procedural Kits Recalled Due to Defective Plastic Syringes
Medline is recalling multiple procedural kits containing defective plastic syringes that may leak or break. The syringes were identified in an FDA Safety Alert issued on March 19, 2024.
Product
Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) PORT DRESSING CHANGE TRAY, Pack Number DT18415; 4) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2723-2024·2024-09-04
Stryker iBur 4.0mm surgical bur recall: excessive heat risk during bone surgery
Stryker iBur 4.0mm precision surgical burs may overheat where the shank meets the distal bushing. Excessive heat could cause minor tissue damage or thermal injury requiring medical intervention.
Product
Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; an
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2732-2024·2024-09-04
Custom Orthopedic Surgical Implant Does Not Match Design Specifications
A custom-made orthopedic surgical implant was supplied for a surgical procedure that did not match the design specifications. This mismatch could affect the proper fit and function of the device during surgery.
Product
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2749-2024·2024-09-04
Medline Circumcision Tray Kits Recalled for Defective Syringes
Medline procedural kits containing circumcision trays are being recalled due to plastic syringes affected by an FDA Safety Alert. The syringes have identified leaks and breakage that may pose risks to patient health.
Product
Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2759-2024·2024-09-04
Medline Procedural Kits Recalled for Syringe Quality Defects
Medline is recalling NEURO TRAY procedural kits (Pack DYNJ55909B, Lot 23IBB122) due to plastic syringe defects including leaks and breakage that may pose a risk to patient health.
Product
Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2722-2024·2024-09-04
Stryker iBur Surgical Bur Recalled Due to Excessive Temperature Risk
Stryker recalls iBur 3.0mm Precision Round surgical burs due to potential for excessive temperatures where the bur shank meets the bushing. Thermal injury risk may require medical intervention.
Product
Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; an
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2724-2024·2024-09-04
Stryker iBur 2.0mm Diamond Round Burr Thermal Hazard Recall
Stryker recalled 1,226 iBur surgical burrs with multiple lot numbers worldwide due to potential overheating at the bur-shank connection point, which could cause tissue damage requiring medical intervention.
Product
Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2735-2024·2024-09-04
Immunoassay analyzer software may delay test processing with automation systems
A software issue in DxI 9000 Access analyzers connected to laboratory automation systems may prevent processing of all samples, flagging tests as timed out and potentially delaying patient results.
Product
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Category
Medical Device
Distribution
Distributed nationwide

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