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 the agency’s own highest classification or reported deaths or serious injuries, 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

21651–21675 of 40175

LowFDA (Devices)·Z-0511-2019·2018-12-05
Numed Multi-Track Angiographic Catheter Recall for Missing Instructions
Numed Inc is recalling 100 units of Multi-Track Angiographic Catheters because Instructions for Use booklets were not included on the outer pouch.
Product
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or…
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-0508-2019·2018-12-05
WOM World of Medicine Recalls PNEUMOCLEAR Heated High-Flow Tube Sets
WOM World of Medicine AG is recalling PNEUMOCLEAR Heated High-Flow Tube Sets because packaging may be damaged by the tube set prongs.
Product
PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0471-2019·2018-11-28
Beckman Coulter Flow Cytometers Recalled for Amplifier Board Defect
Beckman Coulter is recalling Cytomics FC 500 and EPICS XL flow cytometers due to a manufacturing defect on the amplifier board that may cause signal loss or drifting.
Product
1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0472-2019·2018-11-28
Beckman Coulter Flow Cytometers Recalled for Signal Loss Defect
Beckman Coulter is recalling 2,549 flow cytometers worldwide due to a manufacturing defect that may cause signal loss or drifting, potentially affecting patient results.
Product
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0490-2019·2018-11-28
Smiths Medical Recalls Irrisept OR Bottle Assemblies Due to Sterility Risk
Smiths Medical is recalling 10,440 Irrisept OR bottle assemblies because leaking containers may compromise sterility, posing an infection risk.
Product
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Category
Medical Device
Distribution
37 states
SevereFDA (Devices)·Z-0488-2019·2018-11-28
Sedecal NOVA FA DR System Recalled for Potential Cable Failure
Sedecal S.A. is recalling 145 NOVA FA DR diagnostic radiography systems because installation or maintenance issues could cause support cables to break, leading to equipment falling.
Product
Sedecal NOVA FA DR System. for diagnostic radiography.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0478-2019·2018-11-28
Voluntis Recalls Insulia Diabetes Management Companion Due to Calculator Bug
Voluntis is recalling the Insulia Diabetes Management Companion because a bug in the Android basal calculator could cause hypoglycemia. An update is available to resolve the issue.
Product
Insulia Diabetes Management Companion
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-0474-2019·2018-11-28
Boston Scientific Recalls SQ-RX Pulse Generators for Battery Malfunctions
Boston Scientific is recalling 12,900 SQ-RX Pulse Generators used in S-ICD systems due to latent internal battery malfunctions that cause accelerated depletion.
Product
The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0475-2019·2018-11-28
Tosoh AIA-2000 Analyzer Recall Due to Potential Wash Solution Defect
Tosoh Bioscience is recalling seven AIA-2000 analyzers because a liquid suction pump defect may cause incomplete washing, leading to inaccurate test results.
Product
AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0482-2019·2018-11-28
GE Healthcare Recalls Panda iRes Infant Radiant Warmers Due to Electric Leakage
GE Healthcare is recalling 1,724 Panda iRes Infant Radiant Warmers worldwide due to a potential electric leakage hazard that could affect users.
Product
Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0473-2019·2018-11-28
LeMaitre Vascular Recalls Unsealed Polyurethane Carotid Shunts
LeMaitre Vascular is recalling 46 units of Pruitt F3-S Polyurethane Outlying Carotid Shunts because the pouches are not sealed, compromising sterility.
Product
LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0483-2019·2018-11-28
GE Healthcare Recalls Panda Freestanding Infant Warmers Due to Electric Leakage
GE Healthcare is recalling 1,724 Panda Freestanding Infant Warmers worldwide due to a potential electric leakage hazard that could affect users.
Product
Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0481-2019·2018-11-28
GE Healthcare Recalls Giraffe Infant Warmers Due to Electric Leakage Risk
GE Healthcare is recalling 1,724 Giraffe infant radiant warmers worldwide due to a potential electric leakage hazard that could affect users.
Product
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0480-2019·2018-11-28
GE Healthcare Recalls Giraffe Incubator Carestations Due to Electric Leakage
GE Healthcare is recalling 1,724 Giraffe Incubator Carestations worldwide due to a potential electric leakage hazard that could affect users.
Product
Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0486-2019·2018-11-28
Ascom Telligence Nurse Call System Recalled for Communication Failure
Ascom (US) Inc. is recalling 57 units of the Telligence Nurse Call System because a gateway defect may prevent device failures from being displayed at staff consoles.
Product
Ascom Telligence Nurse Call System
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-0479-2019·2018-11-28
GE Healthcare Recalls Giraffe OmniBed Neonatal Incubators Due to Electric Leakage
GE Healthcare is recalling 1,724 Giraffe OmniBed Carestation neonatal incubators worldwide due to a potential electric leakage hazard that could affect users.
Product
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0484-2019·2018-11-28
GE Healthcare Panda Wall Mount Infant Radiant Warmer Recalled for Electric Leakage
GE Healthcare is recalling 1,724 Panda Wall Mount infant radiant warmers worldwide due to a potential electric leakage hazard that could affect users.
Product
Panda Wall Mount warmer. Infant radiant warmer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0489-2019·2018-11-28
Merck Minicon Clinical Sample Concentrators Recalled for Performance Issues
Merck Millipore is recalling Minicon Clinical Sample Concentrators because they may take up to 24 hours to concentrate samples, delaying diagnostic tests.
Product
Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon¿ clinical sample concentrators are for in vitro diagnostic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0476-2019·2018-11-28
Ortho-Clinical VITROS dLDL Reagent Recalled for Negatively Biased Results
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products dLDL Reagent GENs 26 and 27 because the in vitro diagnostic may produce negatively biased results.
Product
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0496-2019·2018-11-28
Zimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch
Zimmer Biomet is recalling eight units of the Vanguard Knee System because the outer carton labels do not match the inner sterile packaging labels.
Product
Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0487-2019·2018-11-28
FDA Mandates Recall of PremierPro Aluminum Adjustable Walkers
SVS LLC is recalling 256 PremierPro Aluminum Adjustable Walkers due to an FDA order for stock recovery and return of imported items.
Product
PremierPro Aluminum Adjustable Walker
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0388-2019·2018-11-28
GE Healthcare Recalls DeltaVision OMX SR Imaging Systems Due to Interlock Defect
GE Healthcare Biosciences is recalling 39 DeltaVision OMX SR Imaging Systems because the safety interlocks are not wired to be single-fault tolerant.
Product
DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0493-2019·2018-11-28
BD Urine Collection Cups May Elevate Red Blood Cell Counts
Becton Dickinson is recalling urine collection cups that may cause slight red blood cell count elevations when used with specific analyzers.
Product
KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0491-2019·2018-11-28
BD Vacutainer Urine Collection Cups Recalled for Potential RBC Count Elevation
Becton Dickinson is recalling BD Vacutainer Urine Collection Cups because they may cause slight elevations in red blood cell counts when used with specific analyzers.
Product
BD Vacutainer Urine Collection Cups, Cat. No. 364941
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0477-2019·2018-11-28
Binding Site Human IgM Kit Recalled for Reduced Accuracy
The Binding Site Group is recalling 108 units of Human IgM Kits due to reduced accuracy in control results and potential out-of-range readings.
Product
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative…
Category
Medical Device
Distribution
14 states

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