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

5176–5200 of 13543

HighFDA (Devices)·Z-3009-2024·2024-09-18
Medline Convenience Kits Recalled Due to Leaks and Breakage in Syringes
Medline Industries is recalling convenience kits containing plastic syringes with leaks, breakage, and other quality issues. The defects were identified in an FDA Safety Alert and may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Number CDS984155F ; 3) ENDOSCOPY KIT , Pack Number DYKE1112 ; 4) ENDOSCOPY KIT , Pack Number DYKE1133A; 5) ENDOSCOPY PACK, Pack Number DYKE1264 ; 6) ENDOSCO
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-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-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-3065-2024·2024-09-18
Siemens Dimension Vista Bilirubin Reagent Cartridges Recalled Due to Underfilled Wells
Siemens Healthcare Diagnostics is recalling one lot of Dimension Vista Total Bilirubin Flex Reagent Cartridges due to underfilled wells during manufacturing. The defect may result in inaccurate test results for calibrators, quality control, and patient samples.
Product
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-2988-2024·2024-09-18
Medline Nerve Block Kits Recalled for Defective Plastic Syringes
Medline is recalling nerve block convenience kits for defective plastic syringes that may leak or break, creating a patient safety risk during medical procedures.
Product
Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137
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-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-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-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-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-3063-2024·2024-09-18
Siemens Atellica CH diagnostic reagent batch may produce biased results
A specific lot of Siemens Atellica CH urinary/cerebrospinal fluid protein reagent (lot 130414) may produce biased quality control results and inaccurate patient test outcomes. Approximately 229 units were distributed in the United States and 935 internationally.
Product
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3115-2024·2024-09-18
Medline Semi-Rigid Suction Liners Recalled Due to Loss of Suction
Medline is recalling 444 NICU admit kits containing semi-rigid suction liners due to potential loss or low suction during intermittent use. Affected units were distributed in the US, Canada, and Panama.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3121-2024·2024-09-18
Medline Surgical Convenience Kits Recalled Due to Suction Loss Risk
Medline Industries is recalling 1,076 surgical convenience kits due to reported adverse events from potential suction loss during use. Products were manufactured from September to November 2023.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS981510L; b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D; c) ORTHO TRAUMA-LF, Pack Number DYNJ900720F; d) KNEE ARTHROSCOPY, Pack Number DYNJ908090C; e) LAMINE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3050-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Syringe Quality Defects
Medline medical convenience kits containing plastic syringes are being recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The FDA Safety Alert issued March 19, 2024, identifies affected syringes used in multiple types of medical procedures.
Product
Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ; 3) OB PROCEDURE-LF , Pack Number CDS981335C ; 4) ROBOTIC PACK-LF , Pack Number CDS981757P ; 5) GYN ROBOTIC , Pack Number CDS981826J ; 6)
Category
Medical Device
Distribution
0 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-3078-2024·2024-09-18
Multiple Syringe Models Recalled for Deviation from FDA Clearance Specifications
Sol-Millennium Medical is recalling multiple syringe models because the distributed products are substantially different from FDA-cleared specifications, with major changes to the intended use.
Product
Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Ex
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3098-2024·2024-09-18
Vital Signs Monitor Recalled Due to Inadequate Battery Warning Labels
Zoe Medical is recalling 6,429 Spacelabs Ultraview DM3 Vital Signs Monitors because labeling does not adequately warn users about risks from damaged or expired batteries.
Product
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-3103-2024·2024-09-18
Diagnostic test shows measurement bias at critical threshold
Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 19-9 test kits due to positive bias in measurements around the critical threshold of 35 U/mL, affecting diagnostic accuracy.
Product
ADVIA Centaur 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: 10491379 SMN: 11206239
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3112-2024·2024-09-18
Medline Suction Liners Recalled Due to Potential Loss of Suction
Medline is recalling 1,616 units of semi-rigid suction liners (ENDO KIT, pack numbers DYKE1350D and DYKE1514B) manufactured September to November 2023 that may lose or provide reduced suction during use.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3094-2024·2024-09-18
Reprocessed Surgical Sealer/Divider Recalled for Potential Packaging Seal Defect
Medline Industries is recalling the ReNewal Reprocessed Covidien LigaSure Impact Sealer/Divider due to a potential incomplete seal on the packaging tray. The recall affects 230 units nationwide.
Product
Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
Category
Medical Device
Distribution
Distributed nationwide

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5176–5200 of 13543