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

10751–10775 of 27647

HighFDA (Devices)·Z-3038-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Syringe Defects
Medline Convenience kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may pose a risk to patient health. Multiple kit types have been distributed worldwide.
Product
Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK-LF , Pack Number DYNJ16121O ; 4) FAMILY PLANNING PACK, Pack Number DYNJ59783C ; 5) NEW LIFE PACK , Pack Number DYNJ69208A ;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3051-2024·2024-09-18
Medline Convenience Kits Recalled Due to Plastic Syringe Quality Defects
Medline Industries is recalling medical convenience kits containing plastic syringes with leaks and breakage issues. These defects may pose risks to patient safety during medical procedures.
Product
Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Number CDS810010K ; 5) RETINA-LF, Pack Number CDS810023G; 6) RETINA-LF, Pack Num
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2984-2024·2024-09-18
Medline medical convenience kits with defective plastic syringes recalled
Medline is recalling medical convenience kits containing plastic syringes with identified quality defects including leaks and breakage. The worldwide-distributed kits may pose a risk to patient health.
Product
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ45495G ; 3) TRACH PACK, Pack Number DYNJ46518G ; 4) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007A ; 5) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007B
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3010-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage
Medline is recalling medical convenience kits due to plastic syringe leaks, breakage, and quality issues that may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST INSERTION PACK-LF , Pack Number DYNJ17634D ; 5) URETEROSCOPY, Pack Number D
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3075-2024·2024-09-18
SOL-CARE and SOL-M syringes recalled for unapproved design modifications
Sol-Millennium Medical Inc. is recalling SOL-CARE and SOL-M syringes with safety needles because the devices are substantially different from FDA-cleared versions, with major modifications to intended use.
Product
Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3058-2024·2024-09-18
Medline Biopsy Tray Convenience Kits Recalled for Syringe Leaks and Breakage
Medline BIOPSY TRAY-LF medical convenience kits (Pack DYNDH1229, Lot 22FBA002) are recalled due to plastic syringe leaks, breakage, and quality issues that may pose risks to patient health.
Product
Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2994-2024·2024-09-18
Medline Vascular IVC Filter Placement Kits Recalled for Syringe Defects
Medline is recalling vascular IVC filter placement kits containing defective plastic syringes due to leaks and breakage that may pose health risks. The affected kits are distributed worldwide.
Product
Medline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Number DYKMBNDL37AH
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3001-2024·2024-09-18
Medline Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage
Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and other quality defects that may pose a risk to patient health. Kits are distributed worldwide.
Product
Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack Number CDS983181D ; 3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ; 4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ; 5) MEDIASTIN
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3102-2024·2024-09-18
Siemens Atellica IM CA 19-9 Test Kit Recall: Measurement Bias in Samples
Siemens is recalling Atellica IM CA 19-9 test kits (Lot 56434535) due to positive bias in measurement of tumor marker levels in some samples, particularly from Asia Pacific regions.
Product
Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 11206239
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3022-2024·2024-09-18
Medline Convenience Kits with Defective Syringes Recalled Due to Leaks and Breakage
Medline Convenience kits containing plastic syringes are recalled worldwide due to leaks, breakage, and quality issues posing risks to patients. Multiple lot numbers from 2020–2023 are affected.
Product
Medline Convenience kits labeled as: SCS-LF, DYNJ902314D
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2975-2024·2024-09-18
HeNe Laser System Allows Key Removal While Operating
Pacific LaserTech's 25-LHP-828 HeNe laser systems allow the key to be removed while operating, violating federal safety requirements. Four units distributed nationwide lack proper controls to prevent unintended laser operation.
Product
25-LHP-828, HeNe Laser System, 35 mW
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3013-2024·2024-09-18
Medline CYSTO PACK Convenience Kits Recalled for Defective Syringes
Medline is recalling CYSTO PACK convenience kits containing defective plastic syringes with leaks and breakage that may risk patient health. Affected worldwide; specific lot numbers provided.
Product
Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3105-2024·2024-09-18
Medline semi-rigid suction liners recalled due to potential suction loss
Medline Industries is recalling specific lots of semi-rigid suction liners due to potential loss of suction or low suction during use. About 1.25 million units distributed in the US, Canada, and Panama are affected.
Product
Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K; c) SEMI RIGID SUCTION LINER WITH TUBING, REF OR527K; d) SEMI RIGID SUCTION LINER WITH TUBING, REF OR529K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3047-2024·2024-09-18
Medline convenience kits recalled for syringe leaks and breakage defects
Medline is recalling surgical convenience kits with plastic syringes that may leak or break. The defects pose a risk to patient safety during procedures.
Product
Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUMCISION TRAY 1.1 , Pack Number CIT6260A ; 4) CIRCUMCISION TRAY 1.3 CM BELL , Pack Number CIT7740; 5) CIRCUMCISION TRAY , Pack Nu
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2998-2024·2024-09-18
Medline surgical convenience kits recalled due to defective plastic syringes
Medline is recalling multiple surgical and medical convenience kits containing plastic syringes affected by a safety alert. Leaks, breakage, and quality issues may affect patient safety during medical procedures.
Product
Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ; 3) BIOPSY DRAPE PACK , Pack Number 00-400762H ; 4) BIOPSY PROCEDURE PACK , Pack Number 00-400832N ; 5) BIOPSY PROCEDURE PACK , Pack Num
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3070-2024·2024-09-18
Medline Sterile Medical Kit with Mislabeled Non-sterile Component Recalled
Medline's KIT PEDI CRANI LAMI sterile kits contain a non-sterile Mastisol component not labeled as such, raising infection risk. 485 units were distributed in Texas, Illinois, and California.
Product
KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-3062-2024·2024-09-18
Guidewire for Hemodialysis Catheters Recalled Due to Incorrect Assembly
Bard is recalling Guidewire 70cm x 1mm (REF 5583705) for hemodialysis catheters due to incorrect assembly. The stiff end may be positioned at the wrong location, risking injury during insertion into a patient.
Product
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3126-2024·2024-09-18
Proton Beam Therapy System Displays Insufficient CBCT Images on Button Press
Hitachi's PROBEAT-CR proton therapy system may display insufficient CBCT images during image positioning when the Float Image Selection button is pressed. This could affect treatment planning accuracy.
Product
Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam wit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3019-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Defective Syringes
Medline Industries recalls numerous sterile procedure kits containing plastic syringes affected by an FDA Safety Alert from March 2024. The syringes may leak or break, posing potential risk to patient health.
Product
Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; 3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N; 4) THORACENTESIS TRAY, Pack Number 00-400616J ; 5) SPECIAL PROCEDURE PACKX-RAY , Pack Numbe
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1807-2024·2024-09-18
American Outdoor Products Astronaut Strawberries Recalled for Elevated Lead Levels
American Outdoor Products' Astronaut Strawberries are being recalled due to elevated lead levels. The recall affects approximately 14,235 units distributed nationwide.
Product
American Outdoor Products - Astronaut Strawberries, packaged in 0.5oz (14g) metallic plastic pouches. Sold individually or in 6, 12, 40, or 160 count cases. One unit is also included in the Outerspace Survival Dessert Kit. Shelf stable.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3008-2024·2024-09-18
Medline Esophagectomy Convenience Kits Recalled for Syringe Leaks and Breakage
Medline Industries recalls esophagectomy convenience kits containing plastic syringes with leaks and breakage issues. The defects may pose a risk to patient health during surgical procedures.
Product
Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3069-2024·2024-09-18
Sterile Surgical Kit Contains Non-Sterile Component Without Label
A non-sterile Mastisol component was included in certain sterile craniotomy packs without proper labeling. If users assume the component is sterile, it could increase infection risk during surgery.
Product
CRANIOTOMY PACK, Pack Number DYNJ46552O
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-3040-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Plastic Syringe Defects
Medline is recalling multiple medical convenience kits containing plastic syringes with quality issues including leaks and breakage. These kits are used for chest procedures and may pose risks to patient health.
Product
Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2941A ; 4) PERICARDIAL DRAIN KIT , Pack Number DYNDA2998; 5) KIT, BEDSIDE THORACENTESIS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3029-2024·2024-09-18
Medical Convenience Kits with Defective Plastic Syringes Recalled Worldwide
Medline medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues that may harm patients. The kits were distributed worldwide and are used for invasive procedures like biopsies and lumbar punctures.
Product
Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 4) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324A; 5) BONE MARROW BIOPS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2986-2024·2024-09-18
Medline medical convenience kits recalled due to syringe quality defects
Medline is recalling multiple medical convenience kits worldwide that contain plastic syringes with defects that may leak or break, posing a risk to patient safety.
Product
Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ; 3) CARDIAC MINOR-LF, Pack Number DYNJ51939; 4) CARDIAC MINOR SURGICOUNT PACK , Pack Number DYNJ56573; 5) PEDIATRIC EP PACKMH
Category
Medical Device
Distribution
0 states

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10751–10775 of 27647