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

10951–10975 of 89674

HighFDA (Devices)·Z-2996-2024·2024-09-18
Medline Convenience Kits Recalled Due to Defective Plastic Syringes
Medline Industries is recalling multiple convenience kits containing plastic syringes with identified quality issues including leaks and breakage. These defects may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack Number CVI5045; 3) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 4) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 5) BIOPSY TRAY, Pack Number D
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2985-2024·2024-09-18
Medline Convenience Kits Recalled Due to Plastic Syringe Quality Issues
Medline is recalling specific convenience kits because they contain plastic syringes with leaks, breakage, or other quality issues that may pose a risk to patient health.
Product
Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPIRATORY BRONCH PACK ; 3) DYNJ80281A , Pack Number OSC BRONCH PACK
Category
Medical Device
Distribution
0 states
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 (Devices)·Z-3006-2024·2024-09-18
Medline Convenience Kits with Plastic Syringes Recalled for Defects
Medline medical convenience kits containing plastic syringes are being recalled due to identified quality issues including leaks and breakage that may pose a risk to patient health. Products were distributed worldwide.
Product
Medline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ; 2) LAVH CDS, Pack Number CDS760049AC; 3) LAPAROSCOPY CDS , Pack Number CDS760051AB; 4) LAPAROSCOPY CDS , Pack Number CDS760051AC; 5) LAPAROSCOPY CDS , Pack Number CDS760051AD; 6) ABDOM
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3024-2024·2024-09-18
Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues
Medline is recalling multiple convenience kits used in medical procedures due to plastic syringe defects including leaks and breakage. No injuries have been reported, but the defects may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2499; 3) ED PREP TRAY, Pack Number DYNDA2519; 4) ED PREP TRAY, Pack Number DYNDA2519H ; 5) PRE-OP PREP KIT , Pack Number DYNDA3076; 6) PILGRIM PREP TRAY
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3106-2024·2024-09-18
Medline Semi-Rigid Suction Liners Recalled for Potential Suction Loss
Medline Industries is recalling anesthesia circuit kits due to reported adverse events indicating potential loss of suction during intermittent use. Approximately 29,585 units distributed in the US, Canada, and Panama are affected.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0311C; b) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0323C; c) ANESTHESIA CIRCUIT ADULT, Pack Number DYNJAA0378A; d) ADULT ANESTHESIA CIRC LAGUNA, Pa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3131-2024·2024-09-18
Surgical Dissector Recalled for Brown Discoloration on Hinge Area
Technomed Europe is recalling NEUROSIGN Disposable Stimulating Dissectors due to brown discoloration or substance on the hinge area. The recall affects 71 units distributed across seven US states.
Product
NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-3023-2024·2024-09-18
Medline Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage
Medline Convenience kits with plastic syringes affected by an FDA safety alert are being recalled due to leaks, breakage, and quality issues that may harm patients.
Product
Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILITY TRAY, Pack Number DYNDA2865; 4) BLOOD CULTURE SET , Pack Number DYNDH1495A ; 5) LACERATION TRAY , Pack Number DYNDL1050; 6) L
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-3044-2024·2024-09-18
Medline medical convenience kits recalled for syringe leaks and breakage
Medline Industries is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. These defects may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR & DELIVERY CDS, Pack Number CDS830039AI; 4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ; 5) LABOR & DELIVERY CDS, Pack Number CD
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3002-2024·2024-09-18
Medline Convenience Kits with Defective Plastic Syringes Recalled Globally
Medline recalls convenience kits with defective plastic syringes due to leaks, breakage, and quality issues identified in an FDA Safety Alert. The defects may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS780161K ; 3) HEAD & NECK CDS , Pack Number CDS780161L ; 4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ; 5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ;
Category
Medical Device
Distribution
0 states
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
HighNHTSA·24V694000·2024-09-18
Fiat 124 Spider Recall: Air Bag Software Error May Cause Excessive Deployment Force
Chrysler is recalling 2017-2020 Fiat 124 Spider vehicles because a software error may cause front air bags to deploy with excessive force, increasing injury risk.
Product
FIAT — FIAT 124 SPIDER
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V697000·2024-09-18
BMW and MINI vehicles brake system failure integrated module welds break
BMW and MINI are recalling certain 2023–2025 vehicles because welds in the brake control module may break, causing loss of power brake assist, rear brakes, and stability control. This increases crash risk.
Product
BMW — BMW, MINI, ROLLS-ROYCE 740I, COOPER, X7, SPECTRE
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V695000·2024-09-18
2016–2023 Mazda MX-5 Air Bag Control Module Software Defect
Mazda is recalling 2016–2023 MX-5 Miata vehicles because a software error in the air bag control module may cause front air bags to deploy with excessive force during a crash, increasing injury risk.
Product
MAZDA — MAZDA MX-5
Category
Vehicle
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-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-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-2992-2024·2024-09-18
Medline Medical Convenience Kits with Defective Syringes Recalled
Medline Industries is recalling convenience kits containing plastic syringes with leaks, breakage, and quality defects identified by an FDA Safety Alert. These defects may pose risks to patient safety during medical procedures.
Product
Medline convenience kits labeled as: 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 ; 5) CATH LAB PACK , Pack Number
Category
Medical Device
Distribution
0 states
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-3007-2024·2024-09-18
Medline Medical Convenience Kits with Defective Plastic Syringes Recalled
Medline is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. The kits are distributed worldwide for procedures including dialysis and spinal procedures. The defects may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD CATHETER, Pack Number CVI4835; 3) DIALYSIS TAKE OFF KIT , Pack Number DT18185; 4) DIALYSIS TRAY , Pack Number DT22005; 5) PRE POST DIALYSIS, Pack Number D
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-3127-2024·2024-09-18
Proton Therapy System May Display Insufficient Images During Treatment Planning
FDA recalls the PROBEAT-V proton beam therapy system due to a software issue where the 3D image positioning mode may display insufficient images, potentially affecting treatment planning accuracy.
Product
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3089-2024·2024-09-18
Proton Therapy System Software Allows Safety Verification Mechanisms to Be Disabled
The IBA Proton Therapy System (PROTEUS 235 and related models) has a software defect allowing safety parameter verification mechanisms to be deactivated during clinical use. This affects 35 units distributed worldwide.
Product
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
Category
Medical Device
Distribution
Distributed nationwide
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

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10951–10975 of 89674