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

14551–14575 of 27500

SevereFDA (Devices)·Z-0746-2020·2020-01-08
Thoratec HeartMate 3 Mobile Power Unit Recalled for Static Electricity Risk
Thoratec Corp. is recalling HeartMate 3 Mobile Power Units because excessive static electricity can cause unrecoverable power loss, potentially reducing blood flow from the left ventricular assist system.
Product
HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0765-2020·2020-01-08
Villa Sistemi Medicali Recalls Apollo DRF X-ray Tables Due to Chain Failure
Villa Sistemi Medicali is recalling seven Apollo DRF X-ray tables because the angulation chain may fail early due to metal fatigue.
Product
Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0766-2020·2020-01-08
Villa Sistemi Medicali Recalls Apollo EZ X-Ray Table Due to Chain Failure
Villa Sistemi Medicali is recalling one Apollo EZ X-ray table because the angulation chain may fail early due to metal fatigue.
Product
Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0747-2020·2020-01-08
Roche Recalls Accu-Chek Guide Blood Glucose Monitoring System Due to Power Issues
Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall affects 318,678 units distributed in the US and 35 other countries.
Product
Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0770-2020·2020-01-08
Carl Zeiss PLEX Elite 9000 Recalled for Electrical Shock Hazard
Carl Zeiss Meditec is recalling 151 PLEX Elite 9000 Swept-Source OCT devices because a design fault may expose operators to hazardous voltage when contacting the metal enclosure.
Product
The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0753-2020·2020-01-08
Medicrea Polyaxial Pedicle Screws Recalled Due to Incorrect Length
Medicrea International is recalling 210 polyaxial pedicle screws that are 50mm long instead of the labeled 45mm, posing a risk of nerve contact and postoperative pain.
Product
Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO PEDICULAR POLIAXIAL 7.5MM x 45MM VITE POLIASSIALE PEDUNCOLARE 7.5MM x 45MM…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0772-2020·2020-01-08
Nucletron Flexitron Brachytherapy Afterloader Recalled for Cable Guide Failure
Nucletron BV is recalling 383 Flexitron brachytherapy afterloader systems due to a component failure that may cause treatment interruption or incorrect source positioning.
Product
There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0748-2020·2020-01-08
Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues
Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues that may affect device performance.
Product
Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0752-2020·2020-01-08
Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues
Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall affects 452,392 units distributed in the US and internationally.
Product
Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0764-2020·2020-01-08
Villa Sistemi Medicali Recalls Apollo X-ray Tables Due to Chain Failure Risk
Villa Sistemi Medicali is recalling three Apollo X-ray tables because the angulation chain may fail early due to metal fatigue.
Product
Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0763-2020·2020-01-08
Villa Sistemi Medicali Recalls Juno DRF X-Ray Systems Due to Chain Failure
Villa Sistemi Medicali is recalling 46 Juno DRF x-ray systems because the angulation chain may fail early due to metal fatigue.
Product
Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0767-2020·2020-01-08
Medtronic Recalls O-arm O2 Imaging Systems Due to Belt Loosening
Medtronic is recalling 90 O-arm O2 Imaging Systems because a manufacturing issue may cause the gantry tractor motor drive belt to loosen, potentially rotating 3D images relative to the patient's physical position.
Product
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0749-2020·2020-01-08
Roche Recalls Accu-Chek Guide Blood Glucose Meters Due to Power Issues
Roche Diabetes Care is recalling 21,094 Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall covers units distributed in the US and 34 other countries.
Product
Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0750-2020·2020-01-08
Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems
Roche Diabetes Care is recalling specific Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues.
Product
Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0022-2020·2020-01-01
Galemed Babi.Plus Pressure Relief Manifold Recalled for Low Venting Pressure
Galemed is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because they may vent gas below standard pressure. The recall covers 14,964 units distributed in North Carolina and Nevada.
Product
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0734-2020·2020-01-01
Medtronic Lamicel Sponges Recalled for Sterilization Dose Deficiency
Medtronic Xomed is recalling Lamicel 20PK 5MM INTL sponges because the routine sterilization dose does not meet the required Sterility Assurance Level.
Product
Lamicel 20PK 5MM INTL
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0021-2020·2020-01-01
Galemed Babi.Plus Bubble PAP Valve Recalled for Pressure Relief Defect
Galemed Corporation is recalling Babi.Plus Bubble PAP Valves because the pressure relief manifold may vent gas below standard pressure.
Product
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0561-2020·2020-01-01
LivaNova SenTiva VNS Therapy Generators Recalled for Potential Device Reset
LivaNova is recalling SenTiva VNS Therapy generators that may reset and become disabled within 60 days of enabling, potentially requiring additional surgery or causing a return of symptoms.
Product
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-0744-2020·2020-01-01
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 FHRWR1000 - 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
HighFDA (Devices)·Z-0725-2020·2020-01-01
GE Healthcare ApexPro Telemetry System Recalled for Cybersecurity Vulnerabilities
GE Healthcare is recalling 11,347 ApexPro Telemetry Systems worldwide due to cybersecurity vulnerabilities in specific server versions connected to hospital networks.
Product
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area.…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0721-2020·2020-01-01
Mazor Robotics Recalls Snapshot Tracker Kits Due to Manufacturing Defects
Mazor Robotics is recalling 93 Snapshot Tracker Kits because they were not manufactured to specifications, potentially causing navigational inaccuracies and patient injury.
Product
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-0726-2020·2020-01-01
GE Healthcare Recalls CIC Pro Central Stations Due to Cybersecurity Vulnerabilities
GE Healthcare is recalling 41,848 CIC Pro Clinical Information Center Central Stations worldwide due to cybersecurity vulnerabilities in connected telemetry systems.
Product
CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0724-2020·2020-01-01
Bard Max-Core Biopsy Instrument Recalled for Firing Failures
Bard Peripheral Vascular Inc is recalling 727,034 units of the Bard Max-Core Disposable Core Biopsy Instrument due to complaints of failure to fire and failure to obtain samples.
Product
BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0727-2020·2020-01-01
GE Healthcare CARESCAPE Central Station Recalled for Cybersecurity Vulnerabilities
GE Healthcare is recalling CARESCAPE Central Station units due to cybersecurity vulnerabilities in specific network-connected versions.
Product
CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data.…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0736-2020·2020-01-01
RayStation Radiation Therapy Software Recalled for Beam Editing Bug
RaySearch Laboratories is recalling RayStation software versions 4.0 through 9.0 because a bug may reset beam settings, requiring dose recalculation.
Product
RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans…
Category
Medical Device
Distribution
Distributed nationwide

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