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 13543

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-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-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-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-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-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-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-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-2589-2024·2024-09-04
Bivona Tracheostomy Tubes Recalled Due to Securement Flange Tear Risk
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because a manufacturing defect may cause the securement flange to tear.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Produc
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
HighFDA (Devices)·Z-2736-2024·2024-09-04
Lab analyzer incorrectly configured for complex testing at waived facilities
Five Afinion 2 lab analyzers were distributed with incorrect configuration, potentially allowing waived laboratories to perform moderately complex assays that could produce erroneous results.
Product
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2748-2024·2024-09-04
Medline Fetal Surgery Kits Recalled Due to Defective Plastic Syringes
Medline Industries is recalling procedural kits containing plastic syringes that may leak or break. The syringes were identified in a March 2024 FDA Safety Alert and may pose a risk to patient health.
Product
Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2) FETAL SURGERY CDS-LF, Pack Number CMPJ26754O
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2751-2024·2024-09-04
Medline Procedural and Medical Kits Recalled for Defective Syringes
Medline is recalling procedural kits worldwide containing plastic syringes with identified leaks and breakage. The defective syringes were identified in an FDA Safety Alert from March 19, 2024, and may pose risks to patients.
Product
Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417A; 3) DRAWER 9L , Pack Number ACC010427A; 4) MEDICATION DELIVERY MODULE, Pack Number ACC010605 ; 5) DRAWER 3, Pack Number
Category
Medical Device
Distribution
0 states
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-2776-2024·2024-09-04
Centurion Procedure Packs with Plastic Syringes Recalled for Leaks and Breakage
Medline Industries is recalling Centurion procedure packs containing plastic syringes due to leaks, breakage, and quality defects that may pose a risk to patient health. The affected products are distributed worldwide.
Product
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack Number MNS11965A; 3) ARTHROGRAPH TRAY, Pack Number MNS12670A; 4) BREAST BIOPSY KIT, Pack Number DYNDH1512; 5) CIRCUMCISION KIT, Pack Numbe
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2750-2024·2024-09-04
Medline Procedural Kits with Defective Plastic Syringes Recalled
Medline procedural kits contain plastic syringes affected by an FDA Safety Alert. The syringes may leak or break, posing risks to patients during medical procedures.
Product
Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOPLASTY PACK-LF , Pack Number DYNJ38988J; 4)FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179A; 5) FREE FLAP TRAM ADD ON PACK, Pa
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2752-2024·2024-09-04
Medline surgical procedure kits recalled due to defective plastic syringes
Medline is recalling surgical procedure kits containing plastic syringes that may leak or break. The kits were distributed worldwide and may pose a risk to patient health.
Product
Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCIS
Category
Medical Device
Distribution
0 states
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-2773-2024·2024-09-04
Medical convenience kits with syringes recalled due to quality issues
Medline Industries is recalling Centurion procedure packs containing plastic syringes affected by an FDA Safety Alert from March 19, 2024. The syringes may have leaks, breakage, or other quality issues that could pose a health risk.
Product
Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number CIT6325; 3) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 4) LUMBAR PUNCTURE TRAY, Pack Number PT215; 5) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2764-2024·2024-09-04
Medline procedural kits recalled for plastic syringe defects
Medline is recalling procedural kits containing plastic syringes with leaks, breakage, and other quality defects. These defects may pose a risk to patient safety.
Product
Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number DYNJ0855117O ; 3) BAI , Pack Number DYNJ53847D ; 4) BASIC EYE PACK, Pack Number DYNJ83699A ; 5) BASIC EYE PACK, Pack Number DYNJ81805; 6) BASIC EYE PACK, Pa
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2627-2024·2024-09-04
Medline Procedure Packs With Syringes Recalled for Quality Defects
Medline Industries has recalled over 1.6 million procedure packs containing syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected packs were distributed worldwide.
Product
Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ;
Category
Medical Device
Distribution
0 states
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-2838-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled
Beaver Visitec International recalls BVI CustomEyes Procedure Packs containing Sol-M brand syringes due to manufacturer's voluntary recall. 130 units distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001020;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2792-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Voluntary Recall
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The recall affects 35 units with Part Number 584770 and is classified as FDA Class II.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584770;
Category
Medical Device
Distribution
Distributed nationwide
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

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5251–5275 of 13543