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

18701–18725 of 40248

ModerateFDA (Devices)·Z-0728-2020·2020-01-01
Cardinal Health Recalls S.M.A.R.T. Stents for Incorrect MRI Labeling
Cardinal Health is correcting labeling on S.M.A.R.T. Nitinol Stent Systems that incorrectly stated they were 'MRI Safe' instead of 'MRI Conditional'.
Product
S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) or 7 French (2.3 mm) sheathed delivery system. The stent is laser…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0743-2020·2020-01-01
Axis-Shield Homocysteine Reagent Recalled for Potential Performance Issues
Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential performance issues detected during routine testing.
Product
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0737-2020·2020-01-01
Diagnostica Stago Recalls STA Unicalibrator Due to Positive Bias
Diagnostica Stago is recalling 5,498 units of STA Unicalibrator because a positive bias was confirmed when compared to International Standards.
Product
STA UNICALIBRATOR (ref. 00675)
Category
Medical Device
Distribution
42 states
ModerateFDA (Devices)·Z-0741-2020·2020-01-01
PTS Test Strips Recalled for Under-Recovery Against Reference Method
Polymer Technology Systems is recalling specific CHOL+HDL+GLU test strips because they show under-recovery when tested against a reference method.
Product
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-0740-2020·2020-01-01
Ortho Clinical Diagnostics Recalls Urine Electrolyte Diluent Due to Instability
Ortho Clinical Diagnostics is recalling Urine Electrolyte Diluent because the product may become unstable when stored in a 2mL cup for 7 days.
Product
Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0729-2020·2020-01-01
Cordis Precise Nitinol Stent System Labeling Correction for MRI Information
Cardinal Health is correcting labeling on Cordis Precise Nitinol Stent Systems because the instructions incorrectly stated the device was MRI Safe instead of MRI Conditional.
Product
Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. The stent is cut from a solid…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0730-2020·2020-01-01
Cardinal Health Recalls S.M.A.R.T. Stents for Incorrect MRI Labeling
Cardinal Health is correcting labeling on S.M.A.R.T. stents that incorrectly stated they were MRI Safe. The correct classification is MRI Conditional.
Product
Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems consist of a self-expanding stent made of Nitinol (nickel-titanium alloy) material that is pre-mounted on an over-the-wire delivery system. The stents…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0723-2020·2020-01-01
Lifelines Neuro Recalls ElectroTek Temporal Sensor Cables for Labeling Errors
Lifelines Neuro is recalling 12 ElectroTek Temporal Sensor Cables due to potential incorrect placement labels that could lead to improper electrode placement during EEG studies.
Product
ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0722-2020·2020-01-01
Lifelines Neuro Recalls ElectroTek EEG Sensor Cables Due to Labeling Error
Lifelines Neuro is recalling eight ElectroTek EEG temporal sensor cables because incorrect placement labels could lead to improper electrode positioning during brain activity studies.
Product
ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0720-2020·2020-01-01
Abbott Recalls Mislabeled Radiofrequency Cannulas Due to Manufacturing Error
Abbott Medical is recalling 470 radiofrequency cannulas that were incorrectly labeled with a 5mm active tip length instead of 10mm.
Product
CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0739-2020·2020-01-01
Ortho Clinical Diagnostics Recalls VITROS 7% BSA Diluent Due to Instability
Ortho Clinical Diagnostics is recalling VITROS 7% BSA diluent because it may become unstable when stored in a 2mL cup for seven days.
Product
7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0738-2020·2020-01-01
Diagnostica Stago Recalls STA System Control N + P Due to Positive Bias
Diagnostica Stago is recalling 5,437 units of STA System Control N + P because a positive bias was confirmed on specific calibrator levels.
Product
STA SYSTEM CONROL N + P (ref. 00678)
Category
Medical Device
Distribution
42 states
ModerateFDA (Devices)·Z-0742-2020·2020-01-01
Axis-Shield Homocysteine Reagent Recalled for Potential Performance Issues
Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential under-recovery of sample results.
Product
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0745-2020·2020-01-01
Tosoh AIA-PACK B12 Pretreatment Set Recalled for Barcode Reading Errors
Tosoh Smd Inc is recalling AIA-PACK B12 Pretreatment Sets due to barcode scanning issues that may delay diagnostic results.
Product
AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0732-2020·2020-01-01
AAP Implantate Drill CS 4.0 Recalled for Incorrect Instructions
AAP Implantate Ag is recalling 7 units of INTEGRA Drill CS 4.0 in Texas due to incorrect instructions for use.
Product
INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-0731-2020·2020-01-01
INTEGRA Drill CS 4.5 Recalled for Incorrect Instructions for Use
AAP Implantate Ag is recalling two units of INTEGRA Drill CS 4.5 in Texas due to incorrect instructions for use.
Product
INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0715-2020·2019-12-25
Arrow Berman Angiographic Catheter Recalled for Potential Leak
Arrow International Inc. is recalling 71 units of Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.
Product
Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0716-2020·2019-12-25
Arrow Berman Angiographic Catheter Recalled for Potential Balloon Leak
Arrow International Inc is recalling specific Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.
Product
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0687-2020·2019-12-25
Southwest Technologies Recalls Mold-Contaminated Elasto-Gel Wound Dressings
Southwest Technologies Inc is recalling Elasto-Gel Absorbent Wound Dressings due to potential mold contamination. The affected sterile dressings were distributed to nine states.
Product
Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0679-2020·2019-12-25
Roche Homocysteine Test Recalled for Calibration Failures and Quality Control Issues
Roche Diagnostics is recalling 82 units of Homocysteine tests due to calibration failures and quality control recovery issues on cobas c 701 and 702 modules.
Product
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0114-2020·2019-12-25
GE Healthcare Recalls Aestiva MRI Systems Due to Cybersecurity Vulnerability
GE Healthcare is recalling 502 Aestiva MRI systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.
Product
Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l)…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0695-2020·2019-12-25
Siemens Artis zee X-Ray System Recalled for Collision Sensor Defect
Siemens is recalling three Artis zee Interventional Fluoroscopic X-Ray Systems because a collision sensor defect may block tabletop movement, potentially delaying or interrupting procedures.
Product
Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0712-2020·2019-12-25
Angiodynamics Recalls 60 Micro-PSD HDR Radiation Therapy Sensors
Angiodynamics, Inc. is recalling 60 Micro-PSD HDR sensors because they may provide readings outside the expected accuracy range.
Product
MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0710-2020·2019-12-25
Angiodynamics Recalls OARtrac PLUS Clinical Detector Units Due to Accuracy Issues
Angiodynamics, Inc. is recalling four OARtrac PLUS Clinical Detector Units because they may produce readings outside the expected accuracy range.
Product
OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0707-2020·2019-12-25
Medtronic Percutaneous Pin Adapter Recall for Potential Rotation
Medtronic is recalling 1,297 percutaneous pin adapters because they may rotate after surgical placement and fail to return to their original position.
Product
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter…
Category
Medical Device
Distribution
Distributed nationwide

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18701–18725 of 40248