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

5301–5325 of 13666

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-3045-2024·2024-09-18
Medline medical convenience kits recalled for defective plastic syringes
Medline is recalling medical convenience kits with plastic syringes affected by quality defects including leaks and breakage. The defective syringes may pose risks to patient safety during medical procedures.
Product
Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Number CDS984187U ; 3) DERMATOLOGY KIT, Pack Number DYNDA1567D; 4) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 5) HSG TRAY, Pack Number DYNDH1453; 6) TRA
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-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-3030-2024·2024-09-18
Medline Convenience Kits with Defective Plastic Syringes Recalled
Medline Industries is recalling multiple 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) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY, Pack Number MNS5070; 3) BREAST BIOPSY TRAY-LF, Pack Number SPEC0058A; 4) BREAST BIOPSY TRAY, Pack Number DYNDH1142A; 5) BREAST BIOPSY TRAY, Pack Number S
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3124-2024·2024-09-18
Blood Pressure Module Fails to Record or Alarm in Hemodialysis Machines
Fresenius hemodialysis machines with BPM3 blood pressure modules may fail to record measurements and will not alarm if cuff tubing is kinked. About 3,718 affected units in the US and Canada could result in undetected blood pressure changes during treatment.
Product
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-3097-2024·2024-09-18
Smith & Nephew Tendon Staples Recalled for Compromised Packaging Sterility
Smith & Nephew is recalling 2,961 units of ROTATION MEDICAL TENDON STAPLES due to improper outer foil pouch sealing that may compromise product sterility. No injuries have been reported.
Product
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
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-2976-2024·2024-09-18
HeNe Laser System Key Control Can Be Removed While Operating
PACIFIC LASERTECH's 25-LHP-928 HeNe laser systems have a safety defect: the key control can be removed while the laser is operating. The company is replacing affected units with corrected key switches.
Product
25-LHP-928, HeNe Laser System, 25 mW
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3025-2024·2024-09-18
Medline convenience kits with defective syringes recalled for quality and safety issues
Medline is recalling medical convenience kits with plastic syringes that may leak or break, posing a risk to patient health. Worldwide distribution is affected.
Product
Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M; 2) MINOR ACUTE PACK-LF, Pack Number DYNJ0484979B
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3072-2024·2024-09-18
Sterile Anesthesia Kits Recalled for Non-Sterile Component Mixing
Medline Industries recalled anesthesia kits containing an unlabeled non-sterile Mastisol component that could be mistakenly assumed sterile during use, creating infection risk. The recall affects 315 units distributed in Texas, Illinois, and California.
Product
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A
Category
Medical Device
Distribution
3 states
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-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-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-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-2983-2024·2024-09-18
Medline Medical Convenience Kits with Plastic Syringes Recalled for Quality Defects
Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality defects that may pose patient health risks following an FDA Safety Alert.
Product
Medline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ; 2) ANES CIRC 90 EXP PEDS 2BV-LF, Pack Number 81842 ; 3) AIRWAY EXAM KIT, Pack Number DYKE1796 ; 4) INTUBATION KIT , Pack Number DYKSCRIPPSIN4; 5) INTUBATION KIT , Pack Number D
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2995-2024·2024-09-18
Medline cardiac and surgical procedure convenience kits recalled worldwide
Medline Industries recalled cardiac and surgical procedure convenience kits distributed worldwide including pacemaker, angiography, and open heart surgery kits.
Product
Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) PACEMAKER TRAY, Pack Number 00-401521F ; 4) FEMORAL PACK, Pack Number 00-401525G ; 5) CARDIAC CATH PACK , Pack Number 00-401561K ;
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-3031-2024·2024-09-18
Medical convenience kits with plastic syringes recalled for leaks and breakage
Medline is recalling medical convenience kits with plastic syringes that may leak or break. The FDA issued a safety alert due to quality defects that could harm patients.
Product
Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Number DYNJAA10295A
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3036-2024·2024-09-18
Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes
Medline is recalling medical convenience kits containing plastic syringes that may leak or break. These quality defects, linked to an FDA safety alert, pose a potential risk to patient health.
Product
Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V; 2) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408VH; 3) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492A ; 4) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492AH; 5)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3017-2024·2024-09-18
Medline Convenience Kits Recalled for Syringe Leaks and Breakage
Medline Convenience kits (MUNCY PACK, DYNJ03097D) are recalled due to plastic syringe defects. Affected units may leak, break, or have quality issues that could pose a risk to patient health.
Product
Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D
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

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5301–5325 of 13666