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

21451–21475 of 40175

ModerateFDA (Devices)·Z-0707-2019·2019-01-16
Siemens Biograph Horizon PET/CT System Recalled for Design Defects
Siemens Medical Solutions USA is recalling 171 Biograph Horizon PET/CT systems worldwide due to improper design or specifications.
Product
Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0705-2019·2019-01-16
Mevion Medical Systems Recalls MEVION S250i Medical Device
Mevion Medical Systems is recalling one MEVION S250i unit due to a dDose1 interlock trip. Treatment may continue via partials.
Product
MEVION S250i
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-0700-2019·2019-01-16
Boston Scientific Recalls IntellaTip MiFi Ablation Catheters in Japan
Boston Scientific is recalling 1,282 IntellaTip MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.
Product
IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0699-2019·2019-01-16
Boston Scientific Recalls Blazer Ablation Catheters Due to Resin Changes
Boston Scientific is recalling 1,282 Blazer Open-Irrigated Ablation Catheters in Japan because resin sub-supplier changes caused material variations not reflected in internal documentation.
Product
Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0701-2019·2019-01-16
Boston Scientific Recalls IntellaNav Ablation Catheters in Japan
Boston Scientific is recalling IntellaNav MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.
Product
IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli…
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0552-2019·2019-01-09
Medtronic StealthStation Cranial Software Recall for Biopsy Depth Gauge Error
Medtronic is recalling StealthStation Cranial and Synergy Cranial software due to an incorrect display of the Biopsy Depth Gauge that resulted in the biopsy of healthy tissue.
Product
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc.…
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-0688-2019·2019-01-09
Ortho-Clinical Diagnostics Recalls VITROS HBeAg Reagent Due to Biased Results
Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS HBeAg Reagent because biotin interference may cause inaccurate test results.
Product
VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0689-2019·2019-01-09
Ortho-Clinical Diagnostics Recalls VITROS NT-proBNP Reagent for Biased Results
Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS NT-proBNP Reagent because it may produce biased results at low biotin concentrations.
Product
VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0687-2019·2019-01-09
Ortho-Clinical Diagnostics Recalls VITROS Anti-HBe Reagent Packs
Ortho-Clinical Diagnostics is recalling VITROS Anti-HBe Reagent Packs because biased results may occur at lower biotin concentrations than indicated in the instructions.
Product
VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0690-2019·2019-01-09
Ultradent Recalls Enamelast Fluoride Varnish Due to Off-Flavor Complaints
Ultradent Products, Inc. is recalling specific lots of Enamelast 5% Sodium Fluoride Varnish because the product may have an unpleasant or off flavor.
Product
Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Cool Mint REF/UP 4352 Rx CONTENTS: 200 x 0.4 ml Unit Dose Label Enamelast Unit Dose 50pk Cool Mint: Enamelast 5% Sodium…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0691-2019·2019-01-09
R&D Systems Recalls Human sTfR ELISA Kits Due to Incorrect Control Card
R&D Systems is recalling 198 Human sTfR ELISA kits because they were packed with the wrong control data card number.
Product
Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0681-2019·2019-01-02
Medical Action Industries Recalls Laparotomy Sponges Due to Sterility Compromise
Medical Action Industries is recalling 2,600 laparotomy sponges because a breach of the sterile barrier may have compromised product sterility.
Product
Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0683-2019·2019-01-02
Medtronic MiniMed Insulin Pumps Recalled for Missing Audio Alerts
Medtronic is recalling specific MiniMed insulin pump models because software version 4.10 may fail to play expected audio sounds during alerts, alarms, or sirens.
Product
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-0674-2019·2019-01-02
Tosoh Bioscience Recalls ST AIA-PACK Testosterone Diagnostic Test Kits
Tosoh Bioscience is voluntarily recalling ST AIA-PACK Testosterone kits due to a Class II defect. The recall covers 26,745 units distributed nationwide.
Product
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0663-2019·2019-01-02
ICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems
ICU Medical is recalling Iced Thermoset Closed-Loop Injectate Delivery Systems due to a defect in the thermoset check valve that may cause leakage.
Product
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-0661-2019·2019-01-02
ICU Medical Recalls Thermoset Room Temperature Injectate Delivery Systems
ICU Medical is recalling 27,250 Thermoset Room Temperature Closed Loop Injectate Delivery Systems due to a defect in the thermoset check valve component that may cause leakage.
Product
Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-0682-2019·2019-01-02
Radiometer ABL800 Analyzer Recalled for Potential Patient Data Mismatch
Radiometer America Inc is recalling 2,131 ABL800 analyzers because software may cause a mismatch between patient demographics and test results.
Product
ABL800 analyzer, model numbers 393-800 and 393-801.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0686-2019·2019-01-02
Elekta Recalls MOSAIQ Oncology Software Due to Isocenter Copying Error
Elekta is recalling MOSAIQ Oncology Information System Version 2.64 because copied treatment fields may retain incorrect isocenter settings for imaging.
Product
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0672-2019·2019-01-02
Tosoh Bioscience Recalls AIA-PACK Folate In Vitro Diagnostic Reagents
Tosoh Bioscience Inc is voluntarily recalling AIA-PACK Folate reagents used for in vitro diagnostic testing due to a Class II safety concern.
Product
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0673-2019·2019-01-02
Tosoh Bioscience Recalls ST AIA-PACK FT3 In Vitro Diagnostic Reagents
Tosoh Bioscience Inc is voluntarily recalling ST AIA-PACK FT3 reagents used for in vitro diagnostic testing of Free Triiodothyronine. The recall covers 24,083 units distributed nationwide.
Product
ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0662-2019·2019-01-02
ICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems
ICU Medical is recalling 1,760 units of Iced Thermoset Closed-Loop Injectate Delivery Systems due to a defect in the thermoset check valve that may cause leakage.
Product
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-0679-2019·2019-01-02
RayStation Software Versions Recalled for Dose Tracking Coordinate Errors
RaySearch Laboratories is recalling specific RayStation software versions because isocenter shifts in dose tracking are incorrectly interpreted.
Product
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-0680-2019·2019-01-02
Baxter Recalls GEM Coupler Forceps Due to Potential Rust
Baxter Healthcare is recalling 123 GEM Coupler Forceps units because of potential rust on the devices. The recall covers nationwide and international distribution.
Product
GEM Coupler Forceps, GEM4183C, packaged individually.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0667-2019·2019-01-02
Abbott Alinity i Estradiol Reagent Kit Recalled for Manufacturing Defect
Abbott is recalling 79 units of Alinity i Estradiol Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument failure.
Product
Alinity i Estradiol Reagent Kit, List Number 07P5020
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0660-2019·2019-01-02
Randox SP CAL (LIQ) Calibrator Recall for Value Sheet Corrections
Randox Laboratories is recalling SP CAL (LIQ) calibrators because value sheets were modified to improve alignment for specific assays.
Product
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
Category
Medical Device
Distribution
5 states

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21451–21475 of 40175