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

5076–5100 of 13449

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-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-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-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-3116-2024·2024-09-18
Medline Semi-Rigid Suction Liners Recalled for Potential Suction Loss
Medline is recalling 1,800 units of semi-rigid suction liners used in anesthesia turnover kits due to reported adverse events related to potential loss of suction during intermittent use. Affected lots were manufactured between September and November 2023.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J
Category
Medical Device
Distribution
Distributed nationwide
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-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-2982-2024·2024-09-18
Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues
Medline is recalling medical convenience kits due to quality issues in plastic syringes, including leaks and breakage that may affect patient safety. Affected products include tracheostomy kits and airway packs distributed worldwide.
Product
Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA Pack with Syringe and Lube, Size 1, Pack Number DYND300010P; 4) Flexible LMA Pack with Syringe and Lube, Size 1.5, Pack Number DY
Category
Medical Device
Distribution
0 states
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-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-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-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-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-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-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-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-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-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-3092-2024·2024-09-18
Medline ReNewal Reprocessed LigaSure Blunt Tip Recalled for Packaging Seal Defect
Medline Industries is recalling 3,618 units of ReNewal Reprocessed Covidien LigaSure Blunt Tip surgical devices due to potential incomplete seals on packaging trays. The seal defect could compromise product sterility.
Product
Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.
Category
Medical Device
Distribution
Distributed nationwide
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-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-3056-2024·2024-09-18
Medical Convenience Kits Recalled for Syringe Leaks and Breakage
Medline Industries is recalling multiple medical convenience kits containing plastic syringes that may leak or break, posing a risk to patient health. The affected kits have been distributed worldwide.
Product
Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number DYNDL1984; 3) CLOSING PACK, Pack Number DYNJ68267A ; 4) SUTURING KIT, Pack Number MNS15015 ; 5) SUTURING KIT, Pack Number MNS15015H; 6) SUTURING SE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3037-2024·2024-09-18
Medline Medical 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 quality issues that may pose patient safety risks. The recall affects multiple pack types distributed worldwide.
Product
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY P
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3128-2024·2024-09-18
Medtronic Venous Cannulae: Wrong Product in Incorrect Packaging
Medtronic Perfusion Systems is recalling 290 units of DLP Single Stage Venous Cannulae due to a manufacturing error where straight-tip cannulae were placed into packaging labeled for right-angle metal-tip cannulae.
Product
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Category
Medical Device
Distribution
Distributed nationwide

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5076–5100 of 13449