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

9726–9750 of 13717

HighFDA (Devices)·Z-1243-2023·2023-03-22
BD Ultra-Fine Insulin Syringes Recalled Due to Nonsterile Condition
Becton Dickinson is recalling BD Ultra-Fine Insulin Syringes (Catalog Number 326719) due to a nonsterile condition that could expose patients to pathogenic microorganisms and local infection. Approximately 80,500 units distributed worldwide are affected.
Product
BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326719
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1262-2023·2023-03-22
da Vinci Surgical System Patient Cart Ballscrew Failure Risk
Intuitive Surgical recalls Patient Side Carts for da Vinci X and Xi surgical systems due to ballscrew failure risk. The failure could cause uncontrolled carriage movement leading to potential tissue injury during surgery. 9 units affected.
Product
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1254-2023·2023-03-22
Amicus MNC Apheresis Kit at Risk of Stress Leak in Centrifuge Packs
Fenwal Inc is recalling certain batches of the Amicus MNC Apheresis Kit due to a potential for centrifuge packs to develop stress leaks. Affected units were distributed nationwide and internationally.
Product
Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1244-2023·2023-03-22
BD Ultra-Fine II insulin syringes recalled for sterility defect
Becton Dickinson recalled 1,472,400 BD Ultra-Fine II insulin syringes due to a sterility defect. The nonsterile syringes pose a risk of local infection at injection sites.
Product
BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1258-2023·2023-03-22
Dimension Tacrolimus Diagnostic Cartridge Recalled for Measurement Imprecision
Siemens is recalling Dimension Tacrolimus diagnostic test cartridges (lots GA2286, GA3047, GA3171) due to confirmed measurement imprecision that could lead to incorrect drug dosing and potential organ failure or toxicity.
Product
Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension¿ clinical chemistry system SMN: 10700795 (DF207)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1246-2023·2023-03-22
Synthes TFN-Advanced Femoral Nail Recalled for Dimensional Labeling Mismatch
Synthes (USA) Products LLC is recalling TFN-Advanced Femoral Nails because labeled measurements do not match actual dimensions. Nails labeled 200mm may be 170mm and vice versa.
Product
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1242-2023·2023-03-22
BD Insulin Syringes Recalled for Nonsterile Condition and Infection Risk
Becton Dickinson is recalling 686,500 units of BD insulin syringes due to a nonsterile condition that may expose patients to pathogenic microorganisms and risk of infection.
Product
BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329461
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1245-2023·2023-03-22
Fusion Bioline Vascular Graft recalled due to manufacturing straightness defect
Maquet Cardiovascular is recalling one Fusion Bioline Vascular Graft from lot 25162546 that failed straightness testing. The graft could reduce blood flow or cause tension, potentially leading to bleeding and pseudo-aneurysm.
Product
Fusion Bioline Vascular Graft, Part number M00201503046B0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1261-2023·2023-03-22
TEMA Axle Small elbow prosthesis recalled due to unapproved component
Limacorporate recalled 5 TEMA Axle Small elbow prostheses due to inclusion of a component not cleared for U.S. marketing. Affected systems were distributed to Texas.
Product
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1239-2023·2023-03-22
BD Insulin Syringes Recalled for Sterility Defect
Becton Dickinson recalls 1.9 million BD Insulin Syringes due to a nonsterility defect that could expose patients to pathogenic microorganisms and local infection risk.
Product
BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329424
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1241-2023·2023-03-22
BD Insulin Syringes Recalled for Potential Nonsterile Condition
Becton Dickinson & Company is recalling 1.17 million BD Ultra-Fine Insulin Syringes due to a nonsterile manufacturing defect that could expose patients to pathogenic microorganisms and increase infection risk.
Product
BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326678
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1255-2023·2023-03-22
Medical Device Apheresis Kit Recalled Due to Stress Leak Risk
Fenwal Inc is recalling 6,564 units in certain lots of Amicus apheresis kits because centrifuge packs may develop a stress leak. No illnesses or injuries have been reported.
Product
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1238-2023·2023-03-22
BD Insulin Syringes Recalled Due to Nonsterile Condition
BD Insulin Syringes (Catalog 329420) are being recalled due to nonsterile conditions that could expose patients to pathogenic microorganisms and increase infection risk. The recall affects 961,000 units distributed worldwide.
Product
BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale. Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329420
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1250-2023·2023-03-22
Arial mobile application recalled for Android loading failures
Securitas Healthcare is recalling the Arial mobile application for Android devices because the app does not load or function properly. Users should stop using the app immediately.
Product
Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of the Arial Emergency and Nurse Call system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1249-2023·2023-03-22
Plato 17 Microcatheter Recalled Due to Loose Particle Risk
Scientia Vascular is recalling Plato 17 Microcatheters due to manufacturing defects that may introduce loose particles into the catheter lumen, potentially causing blood vessel blockage or inflammatory reactions.
Product
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1256-2023·2023-03-22
Ambulance cot may separate due to insufficient epoxy in assemblies
Stryker's Power-PRO 2 ambulance cots may separate at head or foot due to insufficient epoxy. Four affected units in NY and VA should be removed from service immediately.
Product
Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1260-2023·2023-03-22
Bard Mission Disposable Core Biopsy Instrument Kit Recall: Sizing Incompatibility
Bard Peripheral Vascular is recalling certain Bard Mission Disposable Core Biopsy Instrument Kits due to sizing incompatibility between the biopsy instrument and coaxial needle, which could cause procedural delays or needle breakage.
Product
Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1259-2023·2023-03-22
Radiation Therapy Software May Not Properly Execute Heart-Protection Breath Hold
Brainlab ExacTrac Dynamic software used in charged-particle radiation therapy systems may not properly execute Deep Inspiration Breath Hold (DIBH) functionality, a heart-protection technique. The issue affects 56 systems across the United States.
Product
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1253-2023·2023-03-22
In Vitro Diagnostic GI Panel Recalled Due to Temperature Exposure During Shipping
BioFire Diagnostics is recalling FilmArray GI Panel diagnostic kits due to temperature excursions during shipping that may reduce test performance.
Product
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1251-2023·2023-03-22
BioFire BCID2 Diagnostic Panels Recalled for Temperature-Related Performance Issues
BioFire Diagnostics is recalling BioFire BCID2 diagnostic panels that experienced temperature excursions during shipment, which may reduce their performance. Affected kits were distributed in Florida and Georgia.
Product
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1252-2023·2023-03-22
BioFire Respiratory Panel 2.1 Recalled Due to Temperature Shipping Excursions
BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 (RP2.1) diagnostic kits due to temperature excursions during shipping that may reduce device performance.
Product
In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1148-2023·2023-03-15
Cardiosave Rescue intra-aortic balloon pump may shut down unexpectedly
The Cardiosave Rescue intra-aortic balloon pump may suddenly stop working due to communication failure between internal circuit boards, interrupting patient therapy and threatening hemodynamic stability.
Product
Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1146-2023·2023-03-15
Cardiosave Rescue Intra-Aortic Balloon Pumps recalled for connection failure
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to a coiled cord cable connection failure that may cause unexpected device shutdown and loss of communication.
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1145-2023·2023-03-15
Cardiosave Hybrid IABP Devices Recalled for Unexpected Shutdown Risk
Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to a connection failure that may cause unexpected shutdown during use. The failure prevents communication between the device's display head and base unit.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1147-2023·2023-03-15
Cardiosave Hybrid IABP Recalled for Risk of Unexpected Shutdown
The Cardiosave Hybrid intra-aortic balloon pump (IABP) is being recalled because it may unexpectedly shut down due to communication loss between internal components. The shutdown could interrupt therapy in cardiac patients and compromise their hemodynamic stability.
Product
Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 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-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998
Category
Medical Device
Distribution
Distributed nationwide

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9726–9750 of 13717