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

22751–22775 of 40175

LowFDA (Devices)·Z-2919-2018·2018-08-29
Euro Diagnostica Anti-Ro ELISA Kits Recalled for Incorrect Labeling
Euro Diagnostica is recalling Anti-Ro (SS-A) ELISA kits due to incorrect labeling. The label incorrectly states 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin'.
Product
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic…
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-2920-2018·2018-08-29
Euro Diagnostica Anti-Cardiolipin ELISA Kits Recalled for Labeling Error
Euro Diagnostica AB is recalling Anti-Cardiolipin ELISA kits due to incorrect labeling. The kits were incorrectly labeled as 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin.'
Product
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG…
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-2922-2018·2018-08-29
Euro Diagnostica Scl-70 ELISA Kits Recalled for Labeling Error
Euro Diagnostica AB is recalling four Scl-70 ELISA kits due to incorrect distribution labeling. The kits were manufactured by DiaSorin but incorrectly labeled as manufactured by them.
Product
is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2824-2018·2018-08-22
Sorin Platinium CRT-D Recall Due to Pacing and Sensing Loss
Sorin CRM SAS is recalling 16 Platinium CRT-D devices because a hardware defect may cause loss of pacing and sensing, preventing the device from delivering necessary defibrillation.
Product
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-2811-2018·2018-08-22
ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold connection.
Product
61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-2589-2018·2018-08-22
Spacelabs Arkon Anesthesia Delivery System Recalled for Ventilation Failure Risk
Spacelabs Healthcare is recalling 328 Arkon Anesthesia Delivery Systems because they may stop providing mechanical ventilation while in use or idle.
Product
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2791-2018·2018-08-22
Cook Inc. Recalls VentriClear Ventricular Drainage Catheter Sets Due to Endotoxin Failure
Cook Inc. is recalling 250 units of the VentriClear Ventricular Drainage Catheter Set because the product failed endotoxin testing. The recall involves one distributor in Indiana, and the product was not distributed to end users.
Product
VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2825-2018·2018-08-22
Sorin Platinium CRT-D Recall Due to Loss of Pacing and Sensing
Sorin CRM SAS is recalling 10 Platinium CRT-D devices because a hardware issue may cause loss of pacing and sensing, preventing the device from detecting arrhythmias.
Product
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-2799-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
Product
30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-2793-2018·2018-08-22
NxStage Express Fluid Warmer Recalled for Electrical Fire Risk
NxStage Medical is recalling Express Fluid Warmers due to a potential risk of electrical fire if fluid leaks into the power receptacle.
Product
NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2813-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
Product
10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2816-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the luer and manifold.
Product
6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2832-2018·2018-08-22
Beekley TomoSPOT Mammography Skin Markers Recalled for Imaging Artifacts
Beekley Corporation is recalling TomoSPOT skin markers used in mammography because they may create imaging artifacts that mimic calcifications on patient mammograms.
Product
TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2804-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.
Product
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2787-2018·2018-08-22
Wondfo Recalls TCube Oral Fluid Drug Test Cubes Due to Choking Hazard
Guangzhou Wondfo Biotech is recalling 16,000 TCube One Step Multi-Drug Oral Fluid Test Cubes because the saliva collection device may fail, causing the foam tip to dislodge and create a choking hazard.
Product
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2830-2018·2018-08-22
Beekley O-SPOT REF 791 Mammography Markers Recalled for Imaging Artifacts
Beekley Corporation is recalling O-SPOT REF 791 and 791S skin markers because they may create imaging artifacts that mimic calcifications on mammograms.
Product
O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2814-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets with NanoClave Manifold
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.
Product
11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2796-2018·2018-08-22
Hamilton-C3 Ventilator Recalled Due to Control Board Component Defect
Hamilton Medical AG is recalling two Hamilton-C3 ventilators because an out-of-specification control board component may cause the device to shut down and trigger alarms.
Product
Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care…
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-2806-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.
Product
Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2810-2018·2018-08-22
ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold.
Product
38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2788-2018·2018-08-22
Wondfo Recalls TCube Oral Fluid Test Cube Due to Choking Hazard
Guangzhou Wondfo Biotech is recalling 60,000 units of the TCube One Step Multi-Drug Oral Fluid Test Cube because the saliva collection device may dislodge, creating a choking hazard.
Product
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2815-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
Product
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valve, Clamp, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2746-2018·2018-08-22
Mevion Medical Systems Recalls MEVION S250 Proton Beam Therapy Systems
Mevion Medical Systems is recalling seven MEVION S250 and S250i proton beam therapy systems due to unauthorized accessory combinations that may cause patient injury.
Product
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2808-2018·2018-08-22
ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of 150 pouches of smallbore I.V. administration sets with NanoClave manifolds due to potential leaks or component separation.
Product
40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2809-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.
Product
PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer.
Category
Medical Device
Distribution
7 states

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22751–22775 of 40175