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

15601–15625 of 27500

HighFDA (Devices)·Z-1936-2019·2019-07-10
Ortho-Clinical VITROS 350 Chemistry System Recalled for CK Drift
Ortho-Clinical Diagnostics is recalling VITROS 350 Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.
Product
VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1910-2019·2019-07-10
GE Healthcare Recalls Centricity Universal Viewer 6.0 Software
GE Healthcare is recalling Centricity Universal Viewer 6.0 software due to a risk of displaying incorrect patient images from archives.
Product
Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1933-2019·2019-07-10
Ortho-Clinical Diagnostics Recalls VITROS 250 Chemistry System for CK Drift
Ortho-Clinical Diagnostics is recalling 5,020 VITROS 250 Chemistry Systems due to potential negative drift in Creatine Kinase results.
Product
VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR)…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1385-2019·2019-07-03
Vyaire Medical Recalls enFlow Cartridges Due to Aluminum Elution
Vyaire Medical is recalling enFlow Disposable Cartridges because testing showed aluminum elution during fluid warming. The recall covers 5,782,820 units distributed worldwide.
Product
enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1889-2019·2019-07-03
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk
Ethicon is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to a reported incidence of intraoperative bleeding.
Product
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1888-2019·2019-07-03
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk
Ethicon Endo-Surgery Inc is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to reported intraoperative bleeding.
Product
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1879-2019·2019-07-03
GE Healthcare Recalls Replacement ECG Leadwires Due to Defibrillation Risk
GE Healthcare is recalling 58,045 replacement ECG leadwires worldwide because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.
Product
Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1784-2019·2019-07-03
Collins Aerospace TASE 500 Imaging Systems Recalled for Laser Safety Error
Collins Aerospace is recalling TASE 500 Imaging systems because the Nominal Ocular Hazard Distance for the alignment laser was miscalculated.
Product
TASE 500 Imaging systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1867-2019·2019-07-03
Thermo Fisher Isotemp Water Bath Recalled for Assembly Error
Thermo Fisher Scientific is recalling Isotemp 20L General Purpose Water Baths due to assembly errors that may cause the fluid temperature to exceed the user's set point.
Product
Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD20
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1852-2019·2019-07-03
Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head coating may crack, posing a risk of particles falling into the surgical field.
Product
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1869-2019·2019-07-03
Thermo Scientific General Purpose Dynamic Bath Recalled for Assembly Error
Thermo Fisher Scientific is recalling four General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the user's set point.
Product
Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model Number: TSGP20
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1859-2019·2019-07-03
Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling 12 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.
Product
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1855-2019·2019-07-03
Maquet VOLISTA Surgical Lights Recalled Due to Coating Crack Risk
Maquet is recalling 46 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, risking particle contamination in the surgical field.
Product
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1886-2019·2019-07-03
GE Healthcare Recalls Centricity Universal Viewer for Missing Image Warning
GE Healthcare is recalling 292 units of the Centricity Universal Viewer because it may fail to warn users when medical images are missing from exams.
Product
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1863-2019·2019-07-03
Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling 9 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.
Product
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1856-2019·2019-07-03
Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling 7 units of VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field.
Product
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1876-2019·2019-07-03
GE Healthcare Recalls ECG Leadwire Sets Due to Defibrillation Risk
GE Healthcare is recalling ECG leadwire sets because they may reduce energy reaching patients during defibrillation, potentially limiting treatment success.
Product
ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106389-003 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 74 cm/ 29 in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2019·2019-07-03
Thermo Scientific General Purpose Dynamic Bath Recalled for Assembly Error
Thermo Fisher Scientific is recalling three General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the user's set point.
Product
Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Model Number: TSGP28
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1877-2019·2019-07-03
GE Healthcare Recalls ECG Leadwires Due to Defibrillation Energy Reduction
GE Healthcare is recalling 58,045 replacement ECG leadwires because they may reduce energy reaching patients during defibrillation, potentially limiting treatment success.
Product
Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1854-2019·2019-07-03
Maquet VOLISTA Surgical Lights Recalled Due to Coating Crack Risk
Maquet is recalling 65 VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field and causing patient infection.
Product
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1871-2019·2019-07-03
Thermo Scientific Dual GP Bath Recalled for Assembly Error
Thermo Fisher Scientific is recalling four Thermo Scientific General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the set point.
Product
Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath Model Number: TSGP15D
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1864-2019·2019-07-03
Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling 10 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, potentially dropping particles into the surgical field.
Product
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1865-2019·2019-07-03
Thermo Fisher Water Bath Recall Due to Assembly Error
Thermo Fisher Scientific is recalling 10 Fisher Scientific Isotemp water baths because an assembly error may cause the fluid temperature to rise above the user's set point.
Product
Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1210-2019·2019-07-03
Becton Dickinson Recalls SmartSite Syringe Administration Sets Due to Leaking
Becton Dickinson is recalling SmartSite Syringe Administration Sets because they may leak, potentially interrupting infusions or exposing healthcare workers to fluids.
Product
SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1892-2019·2019-07-03
Hitachi PROBEAT-V Proton Therapy System Software Recall
Hitachi is recalling three PROBEAT-V proton therapy systems due to a potential software error that could result in incorrect target positioning during treatment.
Product
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Category
Medical Device
Distribution
3 states

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