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

6201–6225 of 39968

HighFDA (Devices)·Z-2623-2024·2024-09-04
Medline procedure packs with syringes recalled due to leaks and breakage
Medline is recalling procedure packs containing Shenli syringes due to leaks, breakage, and quality issues that may pose risks to patient health. Over 1.6 million units have been distributed worldwide.
Product
Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC LOCAL PACK-LF, pack number DYNJ54607A, 3) LOCAL PACK, pack number DYNJ61839B
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2729-2024·2024-09-04
Stryker iBur surgical bur recalled for potential overheating at junction
Stryker has recalled 1171 units of iBur 5.0mm surgical burs due to potential overheating at the bur shank junction. The overheating could cause thermal injury requiring medical intervention.
Product
Stryker iBur 5.0mm Coarse 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)/ Otorhinolaryngol
Category
Medical Device
Distribution
Distributed nationwide
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-2610-2024·2024-09-04
Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Flange Defect
Smiths Medical is recalling specific lots of Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2738-2024·2024-09-04
DR 800 Digital Radiography X-ray Table Front Lever Chain Potential Failure
Agfa is recalling 141 DR 800 Digital Radiography X-ray systems for potential failure of the table's front lever chain.
Product
DR 800. Digital Radiography X-ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2829-2024·2024-09-04
Voluntary Recall of BVI CustomEyes Procedure Packs With Sol-M Syringes
BVI CustomEyes Procedure Packs containing Sol-M manufactured low dead space and Luer Slip syringes are subject to a voluntary recall. Approximately 142 units were distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000866;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2629-2024·2024-09-04
Medline Procedure Packs with Defective Syringes Recalled Worldwide
Medline recalls approximately 1.7 million procedure packs containing defective Shenli syringes due to leaks and breakage that may pose patient risks. The syringes are affected by an FDA Safety Alert from March 2024.
Product
Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2720-2024·2024-09-04
Medical Device: Ion Endoluminal System Recalled for Instrument Arm Screw Failure
Intuitive Surgical is recalling the Ion Endoluminal System due to potential screw failure in the instrument cart arm, which could cause uncontrolled catheter motion in patient airways.
Product
Ion Endoluminal System, REF: 380748-65
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-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
ModerateFDA (Devices)·Z-2887-2024·2024-09-04
BVI CustomEyes Procedure Packs Recalled for Defective Syringes
BVI is voluntarily recalling CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. A total of 97 units have been distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001602;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2837-2024·2024-09-04
BVI CustomEyes Procedure Packs recalled for containing Sol-M syringes
Beaver Visitec International is recalling 1,955 units of BVI CustomEyes Procedure Packs nationwide because they contain Sol-M syringes subject to a voluntary recall by the manufacturer.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001019;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2892-2024·2024-09-04
BVI CustomEyes Procedure Packs With Sol-M Syringes Recalled
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall affects 478 units distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001624;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2910-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing 1ml syringes manufactured by Sol-Millennium Medical, Inc., distributed nationwide in the United States.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001753;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2822-2024·2024-09-04
BVI CustomEyes Procedure Pack Syringes Voluntarily Recalled Nationwide
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M Inc. due to a voluntary manufacturer recall of certain syringe types distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000759;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2923-2024·2024-09-04
BVI CustomEyes Procedure Packs containing Sol-M syringes recalled
Beaver Visitec International recalls BVI CustomEyes Procedure Packs nationwide due to the inclusion of syringes manufactured by Sol-Millennium Medical that are subject to a voluntary manufacturer recall.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001878;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2863-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M syringes recalled
BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled by the FDA. The affected 1ml Luer Lock and Luer Slip syringes were distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001375;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2869-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes manufactured by Sol-Millennium Medical, Inc. Approximately 70 units have been distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001411;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2808-2024·2024-09-04
BVI Recalls CustomEyes Procedure Packs Containing Recalled Sol-M Syringes
BVI is recalling CustomEyes Procedure Packs because they contain syringes subject to a separate voluntary recall by manufacturer Sol-Millennium Medical. The recall affects 217 units nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000455;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2879-2024·2024-09-04
BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes
BVI CustomEyes Procedure Packs containing Sol-M syringes have been voluntarily recalled. Users of affected packs should discontinue use and contact the manufacturer.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001521;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2889-2024·2024-09-04
BVI CustomEyes Procedure Packs recalled for Sol-M syringe defects
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes due to a voluntary recall initiated by the syringe manufacturer. No illnesses or injuries have been reported.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001608;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2931-2024·2024-09-04
BVI CustomEyes Procedure Packs containing Sol-M syringes recalled
Beaver Visitec International recalls CustomEyes Procedure Packs because they contain Sol-Millennium Medical syringes subject to a voluntary recall. Fourteen units distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2909-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall affects 98 units distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001737;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2926-2024·2024-09-04
BVI CustomEyes Procedure Packs with Sol-M syringes recalled
Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001934;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2846-2024·2024-09-04
BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled
Beaver Visitec International is recalling 1,238 units of BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall is voluntary and affects procedure packs distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001123;
Category
Medical Device
Distribution
Distributed nationwide

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6201–6225 of 39968