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

4701–4725 of 27375

HighFDA (Devices)·Z-2579-2024·2024-08-21
Merit Medical Convenience Kits Recalled for Syringe Leaks and Breakage
Merit Medical is recalling medical convenience kits with defective syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health during procedures.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K05-02166B K05T-00380C K05T-01674B K05T-01863 K05T-01941C K05T-01955 K05T-02138 K05T-02159 K05T-02272G K05T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2620-2024·2024-08-21
Surgical light heads may detach due to weld defects
DKK Dai-Ichi Shomei is recalling 293 Aurora surgical light heads because the frame welds can crack, potentially causing the light head to detach during use. No injuries have been reported.
Product
Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2413-2024·2024-08-21
Dental X-Ray Device Testing Defect May Affect Image Repeatability
Palodex Group Oy recalls the Orthopantomograph OP300 dental x-ray system due to a testing software defect that may allow devices with poor image repeatability to be distributed.
Product
Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2564-2024·2024-08-21
FDA recalls Merit Medical convenience kits due to defective syringes
Merit Medical convenience kits containing plastic syringes are recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected kits are used for vascular and cardiac procedures.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F K0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2617-2024·2024-08-21
Spinal Cord Stimulation Devices May Reset During Charging, Causing Transient Therapy Loss
Boston Scientific spinal cord stimulation implants may reset during routine charging, causing brief loss of therapy. Patients may experience undesired sensations when stimulation restarts, potentially leading to surgical intervention requests.
Product
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2562-2024·2024-08-21
Merit Medical Convenience Kits with Defective Syringes Recalled
Merit Medical convenience kits containing plastic syringes are recalled due to leaks, breakage, and quality issues that may pose risks to patients undergoing cardiac and vascular procedures.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF: K05-00203M K05-00511J K05-00547J K05-00612Q K05-00819A K05-01030H K05-01274D K05-01646 K05-01688A K05-01717B K05-01880K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2558-2024·2024-08-21
Merit Medical Convenience Kits with Recalled Syringes Pose Quality Risks
Merit Medical is recalling convenience kits containing syringes with quality defects including leaks and breakage that may pose patient safety risks in cardiac and vascular procedures.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/angioplasty kit), REF: K12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 To support various vascular or cardiac dia
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2618-2024·2024-08-21
Aurora 7 Surgical Light Heads Recalled for Cracked Weld Frames
DKK Dai-Ichi Shomei is recalling 555 Aurora 7 surgical light heads because frame welds can crack, causing the frame to sag, the housing to crack, or the light head to detach.
Product
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2559-2024·2024-08-21
Merit Medical catheter extractor kits recalled for syringe quality defects
Merit Medical is recalling 3,631 catheter extractor convenience kits due to defective syringes with leaks and breakage. The identified quality issues may compromise patient safety during catheter removal.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Outake, REF CET200 and CET300, The Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2566-2024·2024-08-21
Merit Medical Pressure Monitoring Kits with Defective Syringes Recalled
Merit Medical is recalling 69 convenience kits containing defective syringes that may leak or break, potentially risking patient safety during medical procedures. The kits were distributed nationwide.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring Kit), REF: K11-00382C To support fluid administration into the body and physiological pressure monitoring. To support various v
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2584-2024·2024-08-21
Cepheid Sample Collection Device May Leak Causing Cross-Contamination Risk
Cepheid specimen collection devices may leak after patient samples are inserted, creating risk of biohazard exposure and false positive test results. Affected devices are distributed in medical testing facilities worldwide.
Product
Cepheid, Sample Collection Device, Part: 900-0370
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2619-2024·2024-08-21
Surgical Lights Recalled for Possible Weld Defect and Frame Detachment
DKK Dai-Ichi Shomei Co., Ltd. is recalling 822 Aurora surgical light heads due to a weld defect that could cause the light head to sag, crack, or detach during use.
Product
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2569-2024·2024-08-21
Merit Medical pericardiocentesis kits recalled for syringe defects
Merit Medical convenience kits containing plastic syringes have been recalled nationwide. The syringes have quality issues including leaks and breakage that may pose a risk to patient health.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A The Pericardiocentesis Kit is intended to withdraw fluid from
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2575-2024·2024-08-21
Merit Medical Cardiac Catheter Kits Recalled for Syringe Leaks and Breakage
Merit Medical's Prelude SNAP-H cardiac catheter kits are being recalled because their syringes may leak or break during use, potentially affecting cardiac procedures. No illnesses have been reported.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2560-2024·2024-08-21
Merit Medical Syringes in Convenience Kits Recalled for Leaks and Breakage
Merit Medical convenience kits containing plastic syringes are recalled due to leaks, breakage, and quality defects that may pose a risk to patient health. Approximately 3,647 kits were distributed nationwide.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02 (Custom Syringe Kit), REF: K02-00873A, Inject fluids into, or withdraw fluids from, the body.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2567-2024·2024-08-21
Convenience kits by Merit Medical recalled for syringe defects
Merit Medical convenience kits containing defective syringes have been recalled nationwide. Identified quality issues including leaks and breakage may pose risks during cardiac and vascular procedures.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2578-2024·2024-08-21
Merit Medical convenience kits with recalled plastic syringes may leak or break
Convenience kits from Merit Medical Systems containing recalled plastic syringes have identified quality issues including leaks and breakage that may pose a risk to patient health.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K09T-01138 K09T-04484A K09T-04757F K09T-04835H K09T-07256D K09T-07588B K09T-07611K K09T-07649K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2570-2024·2024-08-21
Merit Medical Convenience Kits Recalled for Defective Plastic Syringes
Merit Medical is recalling 7,442 convenience kits containing defective syringes that may leak or break, posing a risk to patient health.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suction kit), REF: RTT14038MB/A The ReSolve Thoracostomy Tray is indicated for the percutaneous removal of air and fluid from the pleu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2586-2024·2024-08-21
Heated Eye Mask Recalled Due to Detachable Wires and Burn Risk
EYE COMFORT CARE LLC is recalling the UNclog Eye Mask due to safety clips that may allow wires to detach, potentially causing electrical shorts and burn injuries.
Product
Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2571-2024·2024-08-21
Merit Medical Convenience Kits with Recalled Syringes Pose Leak Risk
Merit Medical is recalling 900 convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introducer Catheter), REF: FCL-069-00/A FCL-069-02/A FCL-069-03/A For the introduction of various types of pacing or defibrillator leads and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2574-2024·2024-08-21
Merit Medical cardiac kits contain plastic syringes with quality defects
Merit Medical convenience kits used in cardiac procedures contain plastic syringes with potential leaks and breakage. The defects were identified following an FDA Safety Alert issued March 19, 2024.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2616-2024·2024-08-21
BioButton Remote Monitoring Device Software Accuracy Issue
A software anomaly causes the BioButton remote monitoring wearable device to report skin temperature readings slightly out of specification, affecting accurate health data collection in home and healthcare settings.
Product
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2583-2024·2024-08-21
HeartMate 3 System Controller membrane may lift, risking fluid damage and device failure
Thoratec LLC is recalling 694 HeartMate 3 System Controllers because the UI membrane may lift along the housing, allowing fluid entry that could damage internal circuits and cause loss of power or pump failure.
Product
HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524US; HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT; HeartMate 3 System
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-2568-2024·2024-08-21
Merit Medical convenience kits recalled for syringe leaks and breakage risks
Merit Medical is recalling convenience kits containing syringes with quality defects including leaks and breakage. The recalled kits may pose a risk to patients undergoing vascular and cardiac procedures.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit), REF: K09T-11796F K12T-01558G K12T-01558H K12T-01822 K12T-01852L K12T-02006J K12T-02054 K12T-02091G K12T-02102B K12T-023
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2572-2024·2024-08-21
Merit Medical Convenience Kits with Defective Syringes Recalled
Merit Medical convenience kits containing defective syringes are being recalled for leaks and breakage that may pose a risk to patient health.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude Prestige (Introducer Catheter), REF: PLP-2505/A PLP-2514/A PLP-2516/A The introduction of various types of pacing/defibrillator leads and catheters i
Category
Medical Device
Distribution
Distributed nationwide

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