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

10726–10750 of 27647

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-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-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-3075-2024·2024-09-18
SOL-CARE and SOL-M syringes recalled for unapproved design modifications
Sol-Millennium Medical Inc. is recalling SOL-CARE and SOL-M syringes with safety needles because the devices are substantially different from FDA-cleared versions, with major modifications to intended use.
Product
Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2999-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Defective Plastic Syringes
Medline is recalling medical convenience kits containing plastic syringes affected by quality issues including leaks and breakage. The defects may pose risks during dental and surgical procedures.
Product
Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) ORAL PACK-LF, Pack Number DYNJ0426048L ; 4) ORAL SURGERY PACK-LF, Pack Number DYNJ17477F ; 5) ORAL SURGERY PACK-LF, Pack Number
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3029-2024·2024-09-18
Medical Convenience Kits with Defective Plastic Syringes Recalled Worldwide
Medline medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues that may harm patients. The kits were distributed worldwide and are used for invasive procedures like biopsies and lumbar punctures.
Product
Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 4) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324A; 5) BONE MARROW BIOPS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3040-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Plastic Syringe Defects
Medline is recalling multiple medical convenience kits containing plastic syringes with quality issues including leaks and breakage. These kits are used for chest procedures and may pose risks to patient health.
Product
Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2941A ; 4) PERICARDIAL DRAIN KIT , Pack Number DYNDA2998; 5) KIT, BEDSIDE THORACENTESIS
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-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-3068-2024·2024-09-18
FDA Recalls Transcend Dental Composite Material Due to Manufacturing Defect
Ultradent Products is recalling Transcend Singles Universal Body dental composite resin due to red particulates found during manufacturing. The recall affects approximately 2,450 units distributed in the US and several foreign countries.
Product
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- 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 d
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-3010-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage
Medline is recalling medical convenience kits due to plastic syringe leaks, breakage, and quality issues that may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST INSERTION PACK-LF , Pack Number DYNJ17634D ; 5) URETEROSCOPY, Pack Number D
Category
Medical Device
Distribution
0 states
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-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-3042-2024·2024-09-18
Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes
Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues. These defects may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number CDS78005
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3105-2024·2024-09-18
Medline semi-rigid suction liners recalled due to potential suction loss
Medline Industries is recalling specific lots of semi-rigid suction liners due to potential loss of suction or low suction during use. About 1.25 million units distributed in the US, Canada, and Panama are affected.
Product
Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K; c) SEMI RIGID SUCTION LINER WITH TUBING, REF OR527K; d) SEMI RIGID SUCTION LINER WITH TUBING, REF OR529K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2990-2024·2024-09-18
Medline Convenience Kits Recalled for Syringe Leaks and Breakage
Medline is recalling convenience kits containing plastic syringes following an FDA safety alert. Identified leaks, breakage, and quality issues in these kits may pose a risk to patient health. The affected kits are distributed worldwide.
Product
Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, Pack Number 132701; 3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ; 4) KIT LEFT HEART- LEXINGTON , Pack Number 142643 ; 5) KIT ANGIO CSTM-SETON, P
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-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-3099-2024·2024-09-18
Spacelabs Ultraview DM4 Monitor Recalled for Inadequate Battery Safety Warnings
Zoe Medical is recalling 1506 units of the Spacelabs Ultraview DM4 Vital Signs Monitor due to inadequate labeling about damaged or expired battery risks. The lack of proper warnings could affect device safety.
Product
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
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-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 (Food)·F-1803-2024·2024-09-18
Reser's Rotisserie Chicken Salad Base Recalled for Foreign Material
Reser's Fine Foods is recalling 38 cases of Rotisserie Chicken Salad Base (UPC 71117 14743) due to foreign material contamination. The affected product was distributed in nine states with a 'Use By' date of September 13, 2024.
Product
UPC 71117 14743, Reser s Rotisserie Chicken Salad Base 2lb. (32oz), refrigerated, packaged in an opaque plastic tub with a white printed plastic lid. There are 6 tubs per case.
Category
Food
Distribution
9 states
HighFDA (Food)·F-1797-2024·2024-09-18
Yummy Monkey Organics Popcorn Recalled for Missing Milk Allergen Label
Yummy Monkey Organics Butter & Yeast Popcorn is recalled due to missing milk allergen declaration on the label, creating a risk for milk-sensitive consumers. The recall affects specific batches distributed in California and Oregon.
Product
Yummy Monkey Organics Butter & Yeast Popcorn, Made With Purified Ghee & Nutritional Yeast. UPC 9 96692 66641 2, packaged in a Clear Polyethylene Gusseted Re-closable Bag measured 9 x 12 x 2". Net Wt: 5.25 oz (149g). Manufactured By: Yummy Monkey Organics, LLC 243 Grimes St. Ste.
Category
Food
Distribution
2 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-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

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10726–10750 of 27647