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

10776–10800 of 89674

HighFDA (Devices)·Z-3174-2024·2024-09-25
Hemodialysis tubing may fail to flow if connector is incompletely inserted
B Braun's STREAMLINE FRESENIUS bloodline tubing used in hemodialysis may have a design issue where incomplete insertion of the patient connector prevents proper blood flow during certain procedures. Patients receiving dialysis may experience treatment delays.
Product
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3159-2024·2024-09-25
Convenience kits recalled for containing defective medical syringes
ROi CPS LLC is recalling medical convenience kits distributed with Merit syringes that were subsequently recalled by their manufacturer. Approximately 3,387 kits with multiple lot numbers were affected.
Product
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3172-2024·2024-09-25
Smith & Nephew K-Wire Surgical Device Recall for Packaging Error
Smith & Nephew is recalling K-Wire surgical devices due to a packaging error that resulted in wrong-sized wires being distributed. Healthcare providers may have received incorrectly sized bone fixation fasteners affecting approximately 73 units.
Product
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3143-2024·2024-09-25
Seer Home EEG System Recalled for EMC Non-Compliance
Seer Home System ambulatory EEG devices were recalled due to electromagnetic compatibility non-compliance and manufacturing control deficiencies. The issue may affect signal recording reliability in home EEG monitoring.
Product
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory comp
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3169-2024·2024-09-25
Siemens Atellica Microalbumin Diagnostic Test Kits Recalled for Measurement Error
Siemens Healthcare Diagnostics is recalling Atellica CH and ADVIA Chemistry Microalbumin test kits worldwide because they may not properly measure microalbumin in urine samples, potentially causing falsely low results that could delay diagnosis of kidney disease.
Product
Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3163-2024·2024-09-25
Innovasis spinal fusion devices recalled for implant-inserter interface defect
Innovasis is recalling TxHA PEEK and TxTiHA IBF intervertebral fusion devices due to interfacing issues between the implant and inserter that may prevent proper placement. The recall affects 568 devices distributed nationwide.
Product
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products ar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3164-2024·2024-09-25
Endo Retrieval Pouches Recalled; Tube May Detach During Endoscopic Use
Endo retrieval pouches are recalled because the tube may detach and fall into the surgical site during use. Approximately 81,241 units distributed in Georgia, Missouri, and Pennsylvania are affected.
Product
1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1814-2024·2024-09-25
Kodiak Protein-Packed Power Waffles Recalled for Plastic Film Contamination
Kodiak Cakes LLC is recalling 7,300 boxes of Kodiak Protein-Packed Power Waffles due to soft plastic film contamination. Consumers should not consume the affected product.
Product
KODIAK PROTEIN-PACKED POWER WAFFLES BUTTERMILK & VANILLA NET WT 3.35 lb (53.6oz) 1.52kgCreated & distributed by: KODIAK CAKES PARK CITY, UT 84098 UPC 7 05599 01920 3
Category
Food
Distribution
13 states
HighFDA (Devices)·Z-3165-2024·2024-09-25
Philips Azurion X-ray Systems: Cable Hose Carrier Detachment Risk
Philips recalls Azurion X-ray imaging systems due to potential cable hose carrier detachment from broken plastic or bolts, which may cause parts to fall and create injury risk.
Product
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion 7 B20 722225 Azurion 7 B12 722224 Azurion 7 M20 722223 Azurion 7 M12 722222 Azu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3140-2024·2024-09-25
Alaris EtCO2 Module Model 8300 Recalled Due to Bent Connector
CareFusion 303, Inc. recalls 180 Alaris EtCO2 Module Model 8300 units with potentially bent female connectors that may prevent device operation, risking delays in infusion and monitoring.
Product
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1819-2024·2024-09-25
Wegmans Pecan Blend Recalled Due to Undeclared Almonds
Flagstone Foods LLC is recalling Wegmans Pecan Blend because it contains undeclared almonds, a common allergen. The product was distributed to nine states: DC, DE, MA, MD, NC, NJ, NY, PA, and VA.
Product
Wegmans PECAN BLEND NET WT 16OZ (1LB) 453g Ingredients: Pecans, Cashews, Pistachios, Canola and/or Peanut and/or Cottonseed Oil, Salt. Distributed By: Wegmans Food Markets, Inc. Rochester, NY 14603 UPC 0 77890 31040 3
Category
Food
Distribution
9 states
HighFDA (Devices)·Z-3167-2024·2024-09-25
PHILIPS INTEGRIS X-ray systems cable hose carrier detachment recall
PHILIPS medical X-ray imaging systems may have a cable hose carrier that can detach due to broken plastic or bolts, potentially causing parts to fall and injure clinical staff.
Product
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3141-2024·2024-09-25
Alaris Syringe Module Model 8110 Infusion Pumps Recalled for Bent Connectors
CareFusion's Alaris Syringe Module Model 8110 infusion pumps are being recalled because affected units may have bent female connectors that can prevent device operation and delay infusions. Approximately 20,145 units have been distributed worldwide.
Product
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3145-2024·2024-09-25
GE Healthcare ViewPoint Imaging System Recall for Data Vulnerability
GE Healthcare is recalling three ViewPoint imaging systems due to a software vulnerability in Mirth Connect that could allow unauthorized access and manipulation of patient data.
Product
ViewPoint; system, imaging processing, radiological
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3147-2024·2024-09-25
Boston Scientific Recalls Flexima APDL Drainage Catheter Systems Due to Sterility Risk
Boston Scientific is recalling 89 units of Flexima APDL Drainage Catheter Systems because holes in the sterile barrier may compromise device sterility.
Product
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3179-2024·2024-09-25
B Braun Streamline Bloodline Set Recalled for Potential Occlusion
B Braun Medical Inc. is recalling Streamline Bloodline Sets because incomplete connector insertion may cause flow restrictions during hemodialysis.
Product
STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3176-2024·2024-09-25
Hemodialysis bloodline connector insertion defect may cause flow restriction
B Braun Medical is recalling hemodialysis bloodline tubing because the patient connector may not fully insert into the device, potentially blocking blood flow and delaying treatment. Affected units were distributed nationwide.
Product
STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3146-2024·2024-09-25
Medical imaging systems vulnerable to unauthorized access due to software vulnerability
GE Healthcare ViewPoint 6 medical imaging systems contain a software vulnerability (CVE-2023-43208) in Mirth Connect that could allow unauthorized access and patient data manipulation. 574 units are affected and distributed nationwide.
Product
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3150-2024·2024-09-25
Sump Catheter System Recalled for Potential Sterile Barrier Defect
Boston Scientific is recalling the vanSonnenberg Sump Catheter System Kit because the sterile barrier pouch may have holes that could compromise device sterility. The recall affects 4 units distributed in the US, Colombia, Philippines, and Russia.
Product
vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid collections.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3139-2024·2024-09-25
Alaris PCA Pump Module May Have Defective IUI Connector
CareFusion recalls approximately 10,460 Alaris PCA Module Model 8120 infusion pumps worldwide due to potentially bent female IUI connectors that may prevent proper device operation and delay treatment initiation.
Product
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1813-2024·2024-09-25
Bliss Tree Millet Butter Recalled for Undeclared Milk Allergen
Bliss Tree Millet Butter is being recalled because it contains undeclared milk, a common allergen. The product was distributed to wholesalers and retailers in five states and to online customers nationwide.
Product
Bliss Tree Millet Butter Karasev 200g UPC:8906087451686. Packaged in a box, 13 boxes per case.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3178-2024·2024-09-25
Streamline Bloodline Hemodialysis Sets Recalled for Patient Connector Defect
B. Braun is recalling 9,864,165 Streamline Bloodline Sets nationwide due to incomplete patient connector insertion. The defect may restrict fluid flow during hemodialysis and cause therapy delays.
Product
STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3155-2024·2024-09-25
Shoulder implant recalled due to excessive bacterial endotoxin
Tornier, Inc. is recalling one lot of the Stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS shoulder implant due to bacterial endotoxin exceeding safety specifications. The 5 affected units were distributed in Illinois, Wisconsin, Arizona, Nevada, and South Dakota.
Product
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3181-2024·2024-09-25
HAWK Warming Grid recalled for incorrect expiration date
Safeguard US Operating LLC is recalling the HAWK Warming Grid (Item 59-300) due to an incorrect expiration date. The affected units may not function safely if used beyond the actual expiration date.
Product
HAWK Warming Grid, Item Number: 59-300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3170-2024·2024-09-25
Diagnostic test reagent may produce inaccurately low patient results
Siemens Healthcare's ADVIA Chemistry Microalbumin diagnostic test may produce falsely low results. Eight lots do not meet High-Dose Hook Effect and Prozone Effect specifications, potentially affecting microalbumin detection accuracy.
Product
ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers.
Category
Medical Device
Distribution
Distributed nationwide

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10776–10800 of 89674