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

11176–11200 of 27647

HighFDA (Devices)·Z-2576-2024·2024-08-21
Medical paracentesis procedure kits recalled for syringe leaks and breakage
Merit Medical is recalling paracentesis procedure kits nationwide containing syringes with identified leaks and breakage. The defects may pose a risk to patient health during medical procedures.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF: SPPT-100/D SPPT-5F-10/D SPPT-5F-10L/B SPPT-5F-10S SPPT-5F-12PL SPPT-5F-17PL SPPT-5F-7/D SP
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-2585-2024·2024-08-21
Medical Device Recall: BD Kiestra Urine Culture Software May Cause Inaccurate Results
Becton Dickinson & Co. is recalling the BD Kiestra Urine Culture Application due to a software issue that may cause inaccurate bacterial colony counts. This could impact patient diagnosis and treatment decisions.
Product
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-2565-2024·2024-08-21
Merit Medical Convenience Kits With Recalled Syringes Pose Quality Defect Risks
Merit Medical convenience kits containing recalled syringes are subject to a nationwide recall due to quality defects including leaks and breakage that may pose risks to patient health.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-0
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
HighFDA (Devices)·Z-2621-2024·2024-08-21
Surgical Lighting Equipment Recalled for Cracked Welds and Frame Detachment Risk
Aurora Series surgical light heads are recalled due to cracked welds on the frame. The defects can cause the frame to sag, housing to crack, or the light head to detach.
Product
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (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-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-2561-2024·2024-08-21
Merit Medical convenience kits recalled for syringe leaks and breakage
Merit Medical is recalling 1,390 convenience kits containing plastic syringes with identified quality issues including leaks and breakage. The kits, distributed nationwide, may pose a risk to patient health.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K04-00791A An intravascular administration set is a device used to administer fluids from a container to a patient's vascular syst
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-2563-2024·2024-08-21
Merit Medical convenience kits with syringe quality issues recalled nationwide
Merit Medical is recalling convenience kits containing syringes with quality issues including leaks and breakage that may pose a risk to patients receiving intravenous fluid administration.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids
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-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-2557-2024·2024-08-21
Merit Medical convenience kits recalled for syringe leaks and breakage
Merit Medical convenience kits containing recalled syringes have quality issues including leaks and breakage that may pose a risk to patient health. The recall affects 2,388 kits distributed nationwide.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1729-2024·2024-08-21
Pariva Marinated Labneh Bites Recalled Due to Mold Contamination
Pariva LLC is recalling Pariva Marinated Labneh Bites Za'atar (8 oz) due to potential mold contamination. The product was distributed in seven Northeast states with best-by dates in October or December 2024.
Product
Pariva Marinated Labneh Bites Za'atar; NET WT 8 OZ (225g); INGREDIENTS: YOGURT (CULTURED PASTEURIZED GRADE A MILK & CREAM, SKIM MILK, WHEY PROTEIN CONCENTRATE, SALT AND PECTIN), *SUNFLOWER OIL, *EXTRA VIRGIN OLIVE OIL, SESAME SEEDS, SPICES; CONTAINS: MILK, SESAME; Distributed by,
Category
Food
Distribution
7 states
HighFDA (Food)·F-1706-2024·2024-08-21
Alfa Supply Biscuit Mix Recalled for Undeclared Wheat Allergen
Alfa Supply is recalling Abby's Best Biscuit Mix due to undeclared wheat allergen on the product label. The product was distributed to California, Florida, Virginia, Washington, and Bahrain.
Product
Abby's Best BISCUIT MIX NET WEIGHT 4 LBS. 8 OZ. (2.04 KG) INGREDIENTS: ENRICHED BLEACHED FLOUR***PARTIALLY HYDROGENATED VEGETABLE SHORTENING (CONTAINS SOYBEAN OIL) WITH EMULSIFIER***LEAVENING***BUTTERMILK, SALT, SUGAR, CALSIUM CARBONATE PACKED FOR ABBY'S BEST BY ALFA MANUFACTURIN
Category
Food
Distribution
4 states
HighFDA (Food)·F-1730-2024·2024-08-21
Pariva Marinated Labneh Bites Recalled Due to Potential Mold Contamination
Pariva LLC is recalling Pariva Marinated Labneh Bites Mild Tandoori due to potential mold contamination. Affected products were distributed in Massachusetts, Maine, New Hampshire, Rhode Island, New York, New Jersey, and Connecticut.
Product
Pariva Marinated Labneh Bites Mild Tandoori; NET WT 8 OZ (225g); INGREDIENTS: YOGURT (CULTURED PASTEURIZED GRADE A MILK & CREAM, SKIM MILK, WHEY PROTEIN CONCENTRATE, SALT AND PECTIN), *SUNFLOWER OIL, *EXTRA VIRGIN OLIVE OIL, SPICES; CONTAINS: MILK, Distributed by, Mayur, LLC, 196
Category
Food
Distribution
7 states
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-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-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-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-2573-2024·2024-08-21
Merit Medical Convenience Kits Recalled Due to Defective Syringes
Merit Medical convenience kits containing recalled plastic syringes have quality issues including leaks and breakage that may pose risks during vascular and cardiac procedures. Approximately 5,700 affected kits were distributed nationwide.
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/Angioplasty kit), REF: OPT0242-00 S1279-01 S2953 S2960 S6002 To support various vascular or cardiac diagnostic and interv
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-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 (Food)·F-1737-2024·2024-08-21
Bovine Collagen Peptide Powder Recalled for Potential Salmonella Contamination
Bovine collagen peptide powder manufactured by Nanjing NutraBuilding Bio Tech is being recalled due to potential Salmonella contamination. Affected batches were distributed in Wisconsin.
Product
Bovine Collagen Peptide. Powder, Grade A, Cowhide Source. Net Weight: 20.0 kg. Made in China.
Category
Food
Distribution
1 state
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

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11176–11200 of 27647