Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

24151–24175 of 50442

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-0681-2020·2020-01-08
DeWALT and Stanley Laser Distance Measurers Recalled for Excessive Radiation
Stanley Black & Decker is recalling specific DeWALT and Stanley laser distance measurers because they may emit laser radiation exceeding Class II safety limits.
Product
The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley Fatmax FMHT77506. These products were produced for DeWALT and Stanley by a contract manufacturer.
Category
Consumer Product
Distribution
Distributed nationwide
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
HighNHTSA·20V005000·2020-01-06
Micro Bird Recalls 2015-2019 T-Series Buses for Fire Risk
Micro Bird is recalling 2015-2019 T-Series school buses because an oversized circuit breaker may cause wire overheating and fire.
Product
MICRO BIRD — MICRO BIRD T-SERIES TRANSIT BUS
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·20V004000·2020-01-06
Micro Bird Recalls CT-Series Shuttle Buses Due to Fire Risk
Micro Bird is recalling 2015-2019 CT-Series shuttle buses because an oversized breaker may cause wire overheating and fire. Owners should contact the manufacturer for a free replacement.
Product
MICRO BIRD — MICRO BIRD CT-SERIES
Category
Vehicle
Distribution
Distributed nationwide
HighUSDA FSIS·PHA-01022020·2020-01-02
USDA Alerts on Sun Foods Egg Products Linked to Listeria Outbreak
USDA issued a public health alert for Sun Foods egg products containing ingredients from an FDA recall due to possible Listeria monocytogenes contamination.
Product
Sun Foods — FSIS Issues Public Health Alert for Products Associated with the FDA Almark Foods Recall Due to Possible Listeria Monocytogenes Contamination
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0438-2020·2020-01-01
White Castle Cheeseburgers Recalled for Possible Listeria Contamination
White Castle is recalling specific lots of cheeseburgers due to possible contamination with Listeria monocytogenes. The product was distributed to 52 centers in 24 states.
Product
White Castle Sliders - Cheese Sliders - Cheeseburgers UPC 8298801006 (6pk Cheeseburger), UPC 829880116 (16pk Cheeseburger)
Category
Food
Distribution
0 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 (Food)·F-0441-2020·2020-01-01
Ferris Coffee and Nut Company Recalls R.H. Macy's Roasted Salted Cherries
Ferris Coffee and Nut Company is recalling R.H. Macy's Roasted Salted Cherries due to undeclared cashew, pecan, milk, and soy allergens.
Product
R.H. Macys & Co. Roasted Salted Cherries Berries and Nuts with Dark Chocolate, in 10oz metal tin, UPC - 788709600362
Category
Food
Distribution
15 states
HighFDA (Food)·F-0435-2020·2020-01-01
Ardent Mills Recalls Wild Harvest Organic Flour for E. coli Risk
Ardent Mills LLC is recalling Wild Harvest Organic Unbleached All Purpose Flour due to potential E. coli (STEC) contamination. Consumers should stop using the product.
Product
Wild Harvest Organic Unbleached All Purpose Flour, Net Wt 5 lb. (2.26 kg) in paper bags, UPC 7 11535 50915 8, 8 bags per case.
Category
Food
Distribution
4 states
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 (Food)·F-0461-2020·2020-01-01
Northern Fisheries Recalls Frozen Yellowfin Tuna Steaks Due to Histamine Levels
Northern Fisheries Ltd. is recalling 1,052 cases of frozen yellowfin tuna steaks in Florida, Georgia, New York, Illinois, and Rhode Island due to potential scombrotoxin fish poisoning.
Product
Frozen Yellowfin Tuna Steak, 4 oz. and 6 oz., Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper City, Florida 33328
Category
Food
Distribution
5 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 (Food)·F-0439-2020·2020-01-01
White Castle Sliders Recalled for Possible Listeria Contamination
White Castle is recalling 894,078 cartons of Original Slider Hamburgers due to possible Listeria monocytogenes contamination. The product was distributed to 52 centers in 24 states.
Product
White Castle Sliders - The Original Slider Hamburgers
Category
Food
Distribution
0 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 (Food)·F-0440-2020·2020-01-01
White Castle Jalapeno Cheese Sliders Recalled for Listeria Risk
White Castle is recalling Jalapeno Cheese Sliders due to possible Listeria monocytogenes contamination. The product was distributed to 52 centers in 24 states.
Product
White Castle Sliders - Jalapeno Cheese Sliders - Jalapeno Cheeseburgers, UPC 8298801106 (6pk Jalapeno Cheeseburger)
Category
Food
Distribution
0 states
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