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

7076–7100 of 13512

HighFDA (Devices)·Z-1068-2024·2024-02-21
OriGen Biomedical Accessory Syringe Sets Recalled for Sterilization Incompatibility
OriGen Biomedical is recalling 3,613 cases of accessory syringe sets due to design and material changes that caused loss of gamma sterilization compatibility, resulting in yellowed discoloration and unqualified product status.
Product
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-1067-2024·2024-02-21
Bone void filler recalled due to manufacturing process control issue
Musculoskeletal Transplant Foundation recalled 50 units of AFT Allograft Filler Tubes in Minnesota due to an unqualified manufacturing filling process. The product may have extrudability issues causing extended surgery time.
Product
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1078-2024·2024-02-21
Skin Graft Carrier Recalled for Manufacturing Ratio Defect
Zimmer Surgical Inc. is recalling 3:1 Dermacarrier skin graft carriers due to a manufacturing defect where the ridge pattern is 1.5:1 instead of 3:1, potentially causing tissue damage or additional grafting.
Product
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1088-2024·2024-02-21
Philips CombiDiagnost R90 Fluoroscopy Display May Show Previous Patient Images
Philips CombiDiagnost R90 fluoroscopy systems may display a previous patient's images during radiography examination, potentially showing different image content, format, and size that could affect imaging accuracy.
Product
CombiDiagnost R90 1.1 (709031)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1139-2024·2024-02-21
BIOFIRE BCID2 Blood Culture Panel Recalled for False Positive Candida tropicalis Results
BioFire Diagnostics recalls BIOFIRE BCID2 panels due to false positive Candida tropicalis detection when used with certain BD BACTEC culture vials. The vials contain non-viable organism DNA that triggers incorrect positive results.
Product
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1074-2024·2024-02-21
Impella Catheters: Warnings Added for Potential Fiber Ingestion Risk
Abiomed is adding safety warnings to Instructions for Use for all Impella catheter models to prevent fibers from entering the device, which could result in reduced flow. The warning applies to all Impella models distributed worldwide.
Product
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1077-2024·2024-02-21
Medical Device Recall: Heart-Lung Machine Component Sterile Barrier Defect
The BEQ-HLS 7050 USA HLS Set Advanced 7.0 is recalled due to a compromised sterile barrier on its Emergency Priming Line component. This defect may cause inflammation, sepsis, or infection.
Product
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1056-2024·2024-02-21
Samsung GM85 Mobile X-ray System Welding Frame Defect Arm Fall Risk
NeuroLogica is recalling 261 Samsung GM85 mobile x-ray systems due to a welding defect in the moving arm frame that could cause the arm to fall, risking bodily injury.
Product
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1089-2024·2024-02-21
global Medium embryo culture media recalled for potential development impairment
CooperSurgical is recalling three specific lots of global Medium embryo culture media distributed to fertility clinics worldwide due to performance issues that may impair embryo development during culture.
Product
global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1086-2024·2024-02-21
Quidel Sofia 2 Flu + SARS Test Kits Recalled for Incorrect Expiration Dates
Quidel Corporation is recalling one lot of Sofia 2 Flu + SARS Antigen FIA diagnostic test kits due to incorrect expiration dates on packaging. Kits labeled to expire April 30 and May 31, 2025 actually expire September 12, 2024.
Product
The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differ
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1084-2024·2024-02-21
Stryker Neurovascular Trevo Pro Microcatheter Recalled for Unevaluated Use Statement
Stryker is recalling the Trevo Pro 18 Microcatheter because its instruction manual contains an intended use that the FDA has not evaluated. The recall affects 11 units distributed across the United States.
Product
Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0855-2024·2024-02-14
Cardinal Health Monoject Syringe and Enteral Syringe Removal Due to Manufacturing Changes
Cardinal Health is removing Monoject sterile syringes (Luer-Lock and Enteral with ENFit) from the market due to manufacturing and rebranding changes. Distribution affected US and Canada.
Product
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0857-2024·2024-02-14
Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes
Cardinal Health is recalling all sizes of Monoject sterile syringes—including Luer-Lock and Enteral syringes with ENFit connections—due to manufacturing and rebranding changes. Products distributed across the U.S. and Canada.
Product
Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0847-2024·2024-02-14
Cardinal Health Monoject Enteral Syringes Recalled for Pump Incompatibility
Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) in Lot 230503 and 230701 have compatibility issues with certain feeding pumps and should not be used.
Product
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0849-2024·2024-02-14
Cardinal Health Enteral Feeding Syringes Recalled for Pump Compatibility Issues
Cardinal Health Monoject enteral syringes in sizes 6mL to 60mL have compatibility issues with certain feeding pumps and may not properly connect. Cardinal Health recommends not using these syringes with enteral feeding pumps.
Product
Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0853-2024·2024-02-14
Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes
Cardinal Health is removing all sizes of Monoject sterile syringes and enteral syringes from the market due to manufacturing and rebranding changes. Products were distributed in the US and Canada.
Product
Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0856-2024·2024-02-14
Cardinal Health Monoject sterile syringes recalled due to manufacturing changes
Cardinal Health is recalling all sizes of its Monoject sterile syringes (Luer-Lock and ENFit models) nationwide due to manufacturing and rebranding changes. The FDA classified this as a Class I recall.
Product
Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0842-2024·2024-02-14
HeartMate Touch Communication System recalled for software pump operation defects
Thoratec Corp. is recalling HeartMate Touch Communication Systems (1,560 units) due to software and controller defects causing unexpected LVAD pump starts or stops, potentially affecting patient safety.
Product
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0929-2024·2024-02-14
BrightView Gamma Camera Detector May Fall and Injure Patients
Philips BrightView gamma camera detectors may fall due to component failure, potentially causing patient injury including lacerations and fractures. The FDA is recalling all affected units.
Product
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0854-2024·2024-02-14
Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes
Cardinal Health is removing Monoject sterile syringes in multiple sizes due to manufacturing and rebranding changes. The recall affects products distributed nationwide in the US and Canada.
Product
Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0851-2024·2024-02-14
Cardinal Health Monoject Syringes and Enteral Syringes Removed
Cardinal Health is removing all Monoject sterile syringes and enteral syringes due to manufacturing changes and rebranding efforts. These products are distributed across the U.S. and Canada.
Product
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0858-2024·2024-02-14
Cardinal Health Monoject Sterile Syringes Removed Due to Manufacturing Change
Cardinal Health 200, LLC is recalling all sizes of Monoject brand sterile syringes (both Luer-Lock and ENFit enteral types) due to manufacturing and rebranding changes. The recall expands previous correction actions to a complete product removal.
Product
Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0931-2024·2024-02-14
Gamma Camera Detector May Fall Due to Component Failure
The detector in Philips BrightView XCT gamma cameras may fall unexpectedly due to component failure. If it falls below the center of the gantry, it could cause abrasion, contusion, laceration, or fracture to patients' lower limbs.
Product
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0930-2024·2024-02-14
BrightView X Gamma Camera Detector May Fall, Causing Patient Injury
Detectors in Philips BrightView X gamma cameras may fall unexpectedly due to component failure, risking patient injury including fractures and lacerations.
Product
BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0850-2024·2024-02-14
Cardinal Health Enteral Syringes Recalled for Pump Incompatibility
Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) have compatibility issues with certain feeding pumps. The affected lots should not be used with enteral syringe feeding pumps.
Product
Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
Category
Medical Device
Distribution
Distributed nationwide

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7076–7100 of 13512