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

14051–14075 of 27500

HighFDA (Devices)·Z-1454-2020·2020-03-18
Cardinal Health Recalls Non-Sterile Monoject Hypodermic Safety Needles
Cardinal Health is recalling Monoject Hypodermic Safety Needles because they were shipped as non-sterile despite labeling indicating sterility, posing an infection risk.
Product
Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1456-2020·2020-03-18
Cardinal Health Recalls Non-Sterile Monoject Bluntfill Syringes
Cardinal Health 200, LLC is recalling Monoject Bluntfill syringes that were shipped as non-sterile but labeled as sterile. The firm is not aware of any patient harm.
Product
Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1449-2020·2020-03-18
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit Recalled for Tissue Contact
Medtronic CoreValve LLC is recalling six Simulus 750 Flexible Ring/Band Accessory Kits because demonstration units may have contacted non-human tissue.
Product
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1437-2020·2020-03-11
FDA Recalls LKT200 Perfusion Circuits Due to Leakage Risk
Organ Recovery Systems is recalling 2,274 LKT200 Perfusion Circuits because leakage at the sample port could cause loss of perfusion solution needed for kidney preservation.
Product
LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1430-2020·2020-03-11
Remisol Advance software recalled for remote code execution vulnerability
Normand-Info S.A.S.U. is recalling Remisol Advance software running on unsupported Windows operating systems due to a critical remote code execution vulnerability.
Product
Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
Category
Medical Device
Distribution
51 states
SevereFDA (Devices)·Z-1362-2020·2020-03-11
CareFusion Alaris PCA Module Recalled for Software Errors
CareFusion 303, Inc. is recalling CareFusion Alaris PCA Module, Model 8120 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.
Product
CareFusion Alaris PCA Module, Model 8120
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1415-2020·2020-03-11
DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination
DeRoyal Industries is recalling 2,100 sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1446-2020·2020-03-11
Recall of Covidien Force TriVerse Electrosurgical Devices Due to Packaging Risk
The FDA is recalling 70,361 units of Covidien Force TriVerse Electrosurgical Devices because sterile packaging may be compromised, increasing the risk of infection.
Product
Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1425-2020·2020-03-11
Beckman Coulter Recalls Direct Bilirubin Reagents Due to Interference Risk
Beckman Coulter is recalling Direct Bilirubin Reagents because acetaminophen metabolites may interfere with test results, potentially delaying diagnosis and treatment.
Product
Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge)
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-1361-2020·2020-03-11
CareFusion Alaris Syringe Module Software Error Recall
CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.
Product
CareFusion Alaris Syringe Module, Model 8110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1431-2020·2020-03-11
Bard Biopsy EnCor Probe Recall for Sterility and Function Defects
Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to leaks, suction issues, and failure to obtain samples.
Product
Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-1413-2020·2020-03-11
DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1359-2020·2020-03-11
CareFusion Alaris PC Unit Software Error Recall
CareFusion is recalling Alaris PC units due to software errors that may cause infusion interruptions, alarm failures, or incorrect medication concentrations.
Product
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1416-2020·2020-03-11
DeRoyal Sterile Custom Kits Recalled Due to Unknown Contamination Levels
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1422-2020·2020-03-11
Beckman Coulter Enzymatic Creatinine Reagent Recalled for Potential Diagnostic Interference
Beckman Coulter is recalling Enzymatic Creatinine Reagents because high levels of acetaminophen metabolites may interfere with test results, potentially delaying diagnosis.
Product
Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-1423-2020·2020-03-11
Beckman Coulter Recalls Triglycerides Reagent Due to Acetaminophen Interference
Beckman Coulter is recalling Triglycerides Reagent because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.
Product
Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-1445-2020·2020-03-11
Stryker Connected OR Cart Recalled Due to Monitor Attachment Defect
Stryker is recalling 12 Connected OR Carts because the monitor may not attach correctly, posing a risk of the monitor falling and injuring users.
Product
Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court, San Jose, CA 95138, UDI: 07613327462784 - Product Usage: The Connect OR Cart is a mobile, medical-grade cart intended to store and transport components of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2020·2020-03-11
Siemens Atellica CH Reaction Ring Segment Recalled for Cuvette Defects
Siemens Healthcare Diagnostics is recalling Atellica CH Reaction Ring Segments because defects may allow water contamination, leading to inaccurate test results.
Product
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1418-2020·2020-03-11
DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1432-2020·2020-03-11
Bard Biopsy EnCor Probe Recall for Performance Failures
Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to performance failures including leaks and suction issues.
Product
Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-1429-2020·2020-03-11
Seca Baby Scale Cart Recalled Due to Wheel Detachment Risk
Seca is recalling 254 baby scale carts because wheels can loosen and detach, causing the cart to tip over and potentially injure a baby.
Product
Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-1417-2020·2020-03-11
DeRoyal Sterile Custom Kits Recalled for Unknown Contamination Levels
DeRoyal is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1443-2020·2020-03-11
RespVent Closed Suction System Tracheostomy T-Piece Recall for Connection Defect
Respiratory Therapeutics Group is recalling RespVent Closed Suction System T-Pieces because catheters may not be tightly connected to the thumb port, potentially reducing suction performance.
Product
RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2020·2020-03-11
Beckman Coulter Total Bilirubin Reagent Recalled for Acetaminophen Interference
Beckman Coulter is recalling Total Bilirubin Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.
Product
Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233075 (300 tests/cartridge) and 15099590625597 (400 tests/cartridge)
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-1411-2020·2020-03-11
DeRoyal Sterile Custom Kits Recalled for Unknown Contamination
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden and particulate contamination.
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17
Category
Medical Device
Distribution
2 states

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