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

6001–6025 of 40007

HighFDA (Devices)·Z-3011-2024·2024-09-18
Medline Recalls Dialysis Convenience Kits Due to Syringe Quality Issues
Medline is recalling dialysis convenience kits containing plastic syringes affected by an FDA Safety Alert. Leaks and breakage may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516BH; 3) DIALYSIS PACK , Pack Number DYNJ36932A ; 4) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 5) DIALYSIS ACCESS P
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3020-2024·2024-09-18
Medline Recalls Medical Convenience Kits with Defective Plastic Syringes
Medline Industries is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and quality issues.
Product
Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, Pack Number 946279 ; 3) 20GX6" FEMORAL ART LINE KIT, Pack Number ART1165; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) 3" RADIAL ARTERIAL LINE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3133-2024·2024-09-18
Biolox Taper Sleeve Mislabeling: Wrong Component Size in Hip Replacement
Zimmer GmbH is recalling Biolox Option Taper Sleeves due to mislabeling where packaging labels one neck size but contains the opposite size. These components are used in hip replacement surgery.
Product
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3118-2024·2024-09-18
Medline semi-rigid suction liners recalled for potential loss of suction
Medline Industries recalls MTHZ GYN LAPAROSCOPY convenience kits with semi-rigid suction liners due to potential loss of suction during intermittent use. Affected products were manufactured between September and November 2023.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYNJ909739
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3015-2024·2024-09-18
Medline medical convenience kits with syringes recalled due to leakage and breakage
Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The recall affects kits distributed worldwide.
Product
Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number CVI5080; 3) INCISION & DRAINAGE TRAY, Pack Number DYNDA1063; 4) DRAINAGE ACCESS PACK 319701 , Pack Number DYNJ44599I ; 5) PROCEDURE DRAINAGE KIT, Pack Numb
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3000-2024·2024-09-18
Medline Tonsil and Adenoid Surgical Kits Recalled for Syringe Defects
Medline is recalling Tonsil & Adenoid surgical convenience kits containing defective plastic syringes. The kits may leak or break, posing risks to patient safety.
Product
Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3107-2024·2024-09-18
Medline Surgical Suction Liners Recalled for Potential Loss of Suction
Medline Industries is recalling 1,646 units of semi-rigid suction liners used in surgical kits due to reported adverse events involving potential loss of suction or low suction during intermittent use.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b) ENDO KIT, Pack Number DYKE1558B; c) ENDO KIT, Pack Number DYKE1804A; d) VASCULAR-LF, Pack Number DYNJ900714C; e) MAJOR CARDI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3100-2024·2024-09-18
Medical device diagnostic test shows measurement bias in certain samples
Siemens Atellica IM CA 19-9 diagnostic tests show elevated measurement bias in certain sample ranges, particularly near the clinical threshold. Lot numbers 55974535 and 55975535 were distributed nationwide.
Product
Atellica IM CA 19-9 (50 Test)-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: 10995490
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3052-2024·2024-09-18
Medline surgical convenience kits recalled due to defective plastic syringes
Medline Industries is recalling multiple surgical convenience kits containing defective plastic syringes. The syringes may leak or break, posing a risk to patient health during medical procedures.
Product
Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2987-2024·2024-09-18
Medline Convenience Kits Recalled for Syringe Leaks and Breakage
Medline is recalling medical convenience kits containing defective plastic syringes that may leak or break. The kits are used for epidural and spinal anesthesia procedures and have been distributed worldwide.
Product
Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K ; 2) EPIDURAL CSTM PACK-LF , Pack Number DYNJ0844004; 3) CUSTOM EPIDURAL PACK-LF , Pack Number DYNJ0934752F ; 4) EPIDURAL PACK-LF, Pack Number DYNJ0957053D ; 5) EPIDURAL PACK-LF,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3059-2024·2024-09-18
Medline Medical Convenience Kits Recalled Due to Plastic Syringe Defects
Medline is recalling multiple convenience kits containing plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak or break, potentially posing a risk to patient health.
Product
Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044; 3) NEURO ANGIO PACK, Pack Number DYNDA1431A; 4) BLOOD WITHDRAWAL KIT #2, Pack Number DYNDA1683A; 5) LCPH LAB DRAW KIT ,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3033-2024·2024-09-18
Medline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage
Medline is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose a risk to patient health. The recall affects multiple syringe products distributed worldwide.
Product
Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ; 2) SYRINGE CNTRL 10ML YEL L/L LP , Pack Number DYNJSYCPP10Y ; 3) SYRINGE KIT , Pack Number NAM0004; 4) SYR 10ML L/S, Pack Number OEM11623 ; 5) JAPAN 3ML SYRINGE , Pack Nu
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-3077-2024·2024-09-18
SOL-M Syringes with eccentric tips recalled for regulatory non-compliance
Sol-Millennium Medical Inc. recalls SOL-M eccentric tip syringes (10ml, 20ml, 60ml) worldwide due to substantial differences from FDA-cleared specifications and major modifications to intended use.
Product
Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605; 3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2993-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage
Medline is recalling multiple medical convenience kits containing plastic syringes due to leaks, breakage, and quality defects identified in an FDA Safety Alert. The affected kits are used in various medical procedures.
Product
Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) PERF. ASSOC. CUT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2997-2024·2024-09-18
Medline recalls medical convenience kits with defective plastic syringes
Medline Industries recalls medical convenience kits containing plastic syringes with quality defects including leaks and breakage that may pose risks to patient health. No injuries have been reported.
Product
Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTERIOGRAM TRAY, Pack Number 00-402001T ; 4) ARTERIOGRAM TRAY, Pack Number 00-402001U ; 5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ;
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-3125-2024·2024-09-18
Proton therapy system may display insufficient CBCT images during positioning
Hitachi PROBEAT-FR proton therapy systems may display an insufficient number of CBCT images during 3D positioning when the Float Image Selection button is pressed, potentially affecting treatment planning accuracy.
Product
Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR 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-3074-2024·2024-09-18
Syringes with Needles Recalled for Substantial Design Differences from FDA Approval
Sol-Millennium Medical Inc. is recalling multiple syringe models found to differ substantially from their FDA-cleared designs. The recalled products include SOL-M, SOL-CARE, MEDLINE, MONOJECT, and HENRY SCHEIN branded syringes distributed in the United States and internationally.
Product
Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe
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-3048-2024·2024-09-18
Medline C-Section Convenience Kits Recalled for Syringe Quality Issues
Medline is recalling C-section convenience kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert. The syringes may leak or break, posing a risk to patient health.
Product
Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B ; 2) C-SECTION TRAY, Pack Number AM160C ; 3) C-SECTION CDS , Pack Number CDS820031I ; 4) C-SECTION CDS , Pack Number CDS820031J ; 5) C-SECTION PACK, Pack Number CDS820081K ; 6) C-SECTION PACK, Pack
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3122-2024·2024-09-18
FilmArray 2.0 Diagnostic Instruments Recalled for Calibration Error Affecting Test Results
BioFire Diagnostics is recalling FilmArray 2.0 diagnostic instruments that may have been incorrectly calibrated, leading to false positive and false negative results for infectious disease tests including Salmonella, Giardia, Norovirus, and MRSA.
Product
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3109-2024·2024-09-18
Medline Semi-Rigid Suction Liners Recalled for Potential Loss of Suction
Medline Industries is recalling 407 units of semi-rigid suction liners manufactured between September and November 2023 due to potential loss of suction during intermittent use.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; b) ENT MINOR, Pack Number DYNJ908099B; c) HEAD & NECK, Pack Number DYNJ908101B; d) NASAL FESS, Pack Number DYNJ908105B; e) NASAL-LF, Pa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3119-2024·2024-09-18
Medline Surgical Suction Kits Recalled for Potential Loss of Suction
Medline Industries recalls specific lots of semi-rigid suction liners in C-section convenience kits due to reported adverse events. The liners may lose suction during intermittent use.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number DYNJ909732
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3067-2024·2024-09-18
Dental Composite Resin Recall Due to Red Particulate Contamination
Ultradent Products recalls Transcend Econo Kit dental composite due to red particulates in the material from a manufacturing issue. Affected lot C1464 was distributed to dental professionals in 34 U.S. states and internationally.
Product
Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indir
Category
Medical Device
Distribution
35 states

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6001–6025 of 40007