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

5201–5225 of 13449

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-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-2731-2024·2024-09-04
Stryker iBur 3.0mm surgical burr recalled over thermal hazard
Stryker Corporation is recalling the iBur 3.0mm Precision Match Head surgical burr because it may generate higher-than-specified temperatures during use, potentially causing thermal injury that may require medical intervention.
Product
Stryker iBur 3.0mm Precision Match Head, 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)/ Otorhinolaryngolo
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-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-2747-2024·2024-09-04
Medline Procedural Kits Recalled Due to Defective Plastic Syringes
Medline is recalling multiple procedural kits containing plastic syringes that may leak, break, or have quality defects. These defects may pose a risk to patient health during surgical procedures.
Product
Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4) EAR PACK, Pack Number CMPJ05884J; 5) MZ EAR PACK , Pack Number CMPJ09860D; 6) KIT MAJOR EAR CHRG, Pack
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-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-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-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-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-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-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-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
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-2624-2024·2024-09-04
Medical Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage
Medline Industries is recalling over 1.6 million medical convenience kits containing plastic syringes that may leak or break, posing a potential risk to patient safety. The affected kits are distributed worldwide.
Product
see RES for description
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-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-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-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-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-2728-2024·2024-09-04
Stryker iBur Surgical Bur Recall Due to Excessive Heat Risk
Stryker is recalling iBur 4.0mm Coarse Diamond surgical burs that may overheat during use. Excessive heat could cause tissue or bone damage requiring medical intervention.
Product
Stryker iBur 4.0mm 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)/ Otorhinolaryngolo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2726-2024·2024-09-04
Stryker iBur Diamond Round surgical bur recalled for thermal overheating risk
Stryker iBur 4.0mm Diamond Round surgical burs may reach temperatures higher than specified, potentially causing thermal injury or tissue damage during bone-cutting procedures. Approximately 1,706 affected units have been distributed worldwide.
Product
Stryker iBur 4.0mm 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-2730-2024·2024-09-04
Stryker iBur surgical bur may overheat during bone-cutting procedures
Stryker iBur 3.0mm Diamond Match Head surgical cutting tools may reach temperatures exceeding safe operating limits during bone surgery, potentially causing thermal tissue injury. About 2,507 units worldwide are affected.
Product
Stryker iBur 3.0mm Diamond Match Head, 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
Category
Medical Device
Distribution
Distributed nationwide

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5201–5225 of 13449