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

9976–10000 of 13717

HighFDA (Devices)·Z-1003-2023·2023-02-01
Siemens myNeedle Guide Software: Swapped Orientation Labels in CT Systems
Siemens myNeedle Guide software for CT imaging systems has swapped orientation labels in axial images, which could lead to misorientation during guided procedures. The software requires correction.
Product
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1009-2023·2023-02-01
Abbott Alinity m System Nucleic Acid Testing Device Calibration Recall
Abbott Molecular is recalling 918 Alinity m nucleic acid testing systems due to three identified potential calibration and configuration errors.
Product
Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1015-2023·2023-02-01
Medical Device Manufacturer Recalls VAD Drive Kits With Expired Component
Medline Industries is recalling 1,050 kits of Centurion Medical Products Silver Antimicrobial VAD Drive due to expired components. Affected kits were distributed across New York, Indiana, Florida, New Jersey, and Illinois.
Product
CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1012-2023·2023-02-01
Teleflex Endotracheal Tubes Recalled for Potential Cuff and Balloon Dysfunction
Teleflex is recalling approximately 497 endotracheal tubes worldwide due to potential failure of pilot balloon inflation or cuff deflation, which could interfere with airway management.
Product
Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Inse
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1011-2023·2023-02-01
Endotracheal tubes recalled for potential pilot balloon and cuff malfunction
TELEFLEX LLC recalls 39,690 endotracheal tubes for potential pilot balloon non-inflation or cuff non-deflation. These critical airway devices may not function properly during patient intubation.
Product
Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended fo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1014-2023·2023-02-01
MyDay Toric and Reveal 1 Day Toric Contact Lenses Recalled for Incorrect Power
CooperVision is recalling MyDay Toric and Reveal 1 Day Toric contact lenses because some may have incorrect power, resulting in poor visual acuity. Consumers using affected lots should stop wearing the lenses and consult their eye care provider.
Product
MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1004-2023·2023-02-01
Agfa HealthCare XERO Viewer Medical Imaging Software Class II Defect
Agfa Healthcare has recalled XERO Viewer imaging software due to a software defect that can cause issues with images. The defect affects approximately 110 units distributed across the US and 19 other countries.
Product
Agfa HealthCare Enterprise Imaging XERO Viewer
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1007-2023·2023-02-01
Surgical vision packs with defective welds may affect cataract surgery outcomes
Johnson & Johnson is recalling 384 single-use phacoemulsification packs due to weld defects that may cause surgical delays and corneal swelling during cataract surgery.
Product
Single-Use Packs, REF: OPO80
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1018-2023·2023-02-01
Oxford Partial Knee System Recalled for Compromised Sterile Barrier
Biomet is recalling 7 units of the Oxford Partial Knee System due to improper packaging that compromises the sterile barrier. Incorrect carton sizing forced the device pouch to be folded, creating creases that breach the sterile protection.
Product
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1016-2023·2023-02-01
Intraoperative PTH Test Kits Recalled Due to High Result Variability
Future Diagnostics recalled STAT-IntraOperative-Intact-PTH immunoassay kits due to high coefficient of variability in test results. 342 kits were distributed worldwide.
Product
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1020-2023·2023-02-01
AirQ3 Intubating Laryngeal Airway Recall: Orogastric Tube Size Labeling Discrepancy
SunMed is recalling 43,290 AirQ3 Self Pressurizing Intubating Laryngeal Airways due to a sizing discrepancy between device labeling and actual channel dimensions. Clinicians may need to use a smaller-diameter gastric catheter than indicated.
Product
AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1013-2023·2023-02-01
Baxter ELI 380 Electrocardiograph Recalled After Misdirected Shipment
Baxter recalls one ELI 380 electrocardiograph that was shipped to a customer in Texas by mistake on 26 October 2022. The device was intended for a pilot program only.
Product
Baxter Electrocardiograph, ELI 380 -DCS21
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1019-2023·2023-02-01
Air-Q3 intubating laryngeal airway size labeling discrepancy between IFU and device
SunMed's Air-Q3 intubating laryngeal airway devices have a discrepancy between the Instructions For Use and the printed text on the device regarding orogastric tube sizes, which could cause confusion when placing gastric catheters.
Product
Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0886-2023·2023-01-25
Cardiosave IABP may shut down unexpectedly due to blood contamination
The Cardiosave Rescue Intra-Aortic Balloon Pump may shut down unexpectedly if blood enters the device through a compromised balloon catheter. Approximately 46 units have been distributed worldwide.
Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0926-2023·2023-01-25
Medical device controller software update addresses critical failure
Cardiac Assist is issuing a software update for LifeSPARC Controller units that may experience critical failure causing the system to freeze, crash, or lose display functionality. Affected units are identified by specific serial numbers.
Product
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0885-2023·2023-01-25
Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly
The Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly when blood enters the device through a compromised balloon catheter during use.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0996-2023·2023-01-25
Vasoshield Syringe Packs Recalled Due to Chipping Ink Risk
Maquet Cardiovascular is recalling Vasoshield Syringe Packs (Model VH-5001) because ink on the syringe logo may chip, creating a risk of foreign body complications and embolic events. The recall affects 530 units in the United States and 215 units outside the United States.
Product
Vasoshield Syringe Packs, Model VH-5001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0993-2023·2023-01-25
Cardinal Health Jackson-Pratt Wound Drain Recall Due to Performance Defects
Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. The worldwide recall affects units used in post-operative wound drainage.
Product
Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0968-2023·2023-01-25
Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects
Cardinal Health is recalling 4,111 Jackson-Pratt Channel Drains (10 Fr) due to multiple performance issues including dull trocars, broken tips, reduced flexibility, and lack of radiopacity that may affect device function.
Product
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0967-2023·2023-01-25
Cardinal Health Jackson-Pratt Channel Drains Recalled for Performance Defects
Cardinal Health is recalling 1,150 Jackson-Pratt Channel Drains due to multiple performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken tips affecting post-surgical wound drainage.
Product
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0979-2023·2023-01-25
Cardinal Health Jackson-Pratt Drain Recalled for Multiple Performance Issues
Cardinal Health is recalling Jackson-Pratt Channel Drains due to multiple performance issues including dull trocars, lack of radiopacity, reduced flexibility, and broken tips. The affected devices were distributed worldwide.
Product
Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0970-2023·2023-01-25
Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects
Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance defects including dull trocars, broken tips, and radiopacity issues. 921 units affected worldwide.
Product
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0976-2023·2023-01-25
Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects
Cardinal Health Jackson-Pratt Channel Drains are recalled for performance defects including dull trocars, broken tips, lack of flexibility, and lack of radiopacity. 220 units are affected.
Product
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0990-2023·2023-01-25
Jackson-Pratt Surgical Drain Recalled Due to Performance Defects
Cardinal Health is recalling 4,372 Jackson-Pratt Channel Drains due to multiple performance issues: lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.
Product
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0986-2023·2023-01-25
Cardinal Health Jackson-Pratt Drain Recalled for Performance Defects
Cardinal Health is recalling Jackson-Pratt Channel Drains (15 Fr, REF JP-2228) due to multiple performance issues including dull trocars, broken wound tips, lack of radiopacity, and inflexibility. The recall affects approximately 15,493 units distributed worldwide.
Product
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228
Category
Medical Device
Distribution
Distributed nationwide

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9976–10000 of 13717