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

20276–20300 of 40248

ModerateFDA (Devices)·Z-1920-2019·2019-07-10
Siemens SOMATOM go.Now CT Systems Recalled for Performance Issues
Siemens is recalling 69 SOMATOM go.Now CT systems due to potential performance problems that may cause diagnostic delays or the need for patient rescans.
Product
SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1946-2019·2019-07-10
Zimmer Biomet Recalls DVR Crosslock ePAK Screw Drivers Due to Packaging Seal Risk
Zimmer Biomet is recalling 3,022 DVR Crosslock ePAK Screw Drivers because sterile packaging seals may be weak, potentially compromising sterility.
Product
DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1917-2019·2019-07-10
Siemens SOMATOM go.All CT Systems Recalled for Performance Issues
Siemens is recalling 24 SOMATOM go.All CT systems due to sporadic performance problems that may interrupt scanning workflows and delay diagnoses.
Product
SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1948-2019·2019-07-10
Zimmer Biomet Recalls K-Wire Trochar Tips Due to Packaging Seal Issues
Zimmer Biomet is recalling K-Wire Trochar Tips because the sterile packaging may have weak seals, potentially compromising the device's sterility.
Product
K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1938-2019·2019-07-10
Cardiac Science Recalls Five Powerheart G5 Automatic External Defibrillators
Cardiac Science is recalling five Powerheart G5 AEDs because sub-supplier documentation is insufficient to verify that the printed circuit boards conform to specifications.
Product
Powerheart¿ G5 Automatic AED
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1906-2019·2019-07-10
Bio-Rad Recalls EVOLIS Microplate System Due to Software Error
Bio-Rad is recalling 213 EVOLIS Microplate Systems because a software defect may cause erroneous test results to be transmitted to laboratory information systems.
Product
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1932-2019·2019-07-10
Medtronic Recalls 0-arm 1000 Imaging Systems Due to Charger Board Defect
Medtronic is recalling 832 0-arm 1000 Imaging Systems worldwide because a defective charger board prevents batteries from fully recharging, rendering the system inoperable.
Product
Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R BASE OARM 8170000027100 SYSTEM…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1947-2019·2019-07-10
Zimmer Biomet Recalls DVR Crosslock ePAK Depth Gauges for Packaging Defects
Zimmer Biomet is recalling DVR Crosslock ePAK Depth Gauges due to a potential for weak seals in the sterile packaging.
Product
DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1918-2019·2019-07-10
Siemens SOMATOM go.Top CT Systems Recalled for Performance Issues
Siemens Medical Solutions is recalling 30 SOMATOM go.Top CT systems due to potential performance problems that may interrupt scanning workflows and delay patient diagnoses.
Product
SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1937-2019·2019-07-10
Beckman Coulter iChem VELOCITY Urine Strips Recalled for False Positives
Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Strips because increased sensitivity causes falsely elevated urobilinogen results.
Product
iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1921-2019·2019-07-10
Siemens SOMATOM go.All CT Scanner Recalled for Performance Issues
Siemens is recalling 69 SOMATOM go.All CT scanners due to potential performance problems that may cause diagnostic delays or require patient rescans.
Product
SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1893-2019·2019-07-10
Recall of 25GA Vitrectomy Cutters Due to Packaging Error
Johnson & Johnson is recalling 392 units of 25GA Vitrectomy Cutters because 20GA cutters may be found in the packaging, posing a surgical risk.
Product
Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use)
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-1907-2019·2019-07-10
Phadia EliA RF IgM Well Recalled for Potential Low Assay Results
Phadia Ab is recalling EliA RF IgM Well kits due to a potential for reporting low assay results, which may affect rheumatoid arthritis diagnosis.
Product
EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1922-2019·2019-07-10
Siemens CT System Recalled for Potential Scanning Workflow Interruptions
Siemens Medical Solutions is recalling 69 SOMATOM go.Top CT systems due to potential sporadic performance problems that may cause diagnostic delays or the need for patient rescans.
Product
SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1914-2019·2019-07-10
Siemens Recalls Atellica CH Creatine Kinase Reagent Due to Absorbance Trend
Siemens Healthcare Diagnostics is recalling 899 units of Atellica CH Creatine Kinase (CK_L) Reagent because a steady upward trend in blank absorbance was observed.
Product
Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1927-2019·2019-07-10
Roche cobas p 501 Post-Analytical Units Recalled for Loose Flap
Roche Diagnostics is recalling four cobas p 501 post-analytical units because the tray input flap may become loose and detach from the instrument.
Product
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1928-2019·2019-07-10
Roche cobas p 701 Post-Analytical Units Recalled for Loose Flap
Roche Diagnostics is recalling nine cobas p 701 post-analytical units because the tray input flap may become loose and detach.
Product
cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
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-1386-2019·2019-07-03
Vyaire Medical Recalls enFlow Disposable Cartridges Due to Aluminum Elution
Vyaire Medical is recalling enFlow Disposable Cartridges with IV Extension Sets because testing showed aluminum elution during fluid warming.
Product
enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (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
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

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20276–20300 of 40248