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.

14951–14975 of 53092

HighFDA (Devices)·Z-0753-2023·2022-12-28
GE Vivid S6 Ultrasound Systems Recalled for Battery Fire Risk
GE Vivid S6 ultrasound systems are recalled for a potential battery hazard. If not replaced at the recommended 2-year interval, batteries may fail, emit smoke, or catch fire.
Product
Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0732-2023·2022-12-28
GE B125M Patient Monitor CO2 Measurement Inaccuracy at High Elevations
GE B125M patient monitors may display inaccurate CO2 measurements at high elevations when using mmHg or kPa units. Measurement accuracy can be affected in locations significantly above sea level.
Product
B125M Patient Monitor, REF 6160000-004-XXXXXX
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0457-2023·2022-12-28
SurfaceSoap UV Disinfecting Wand Recalled for Excessive Ultraviolet Radiation
PhoneSoap has recalled its SurfaceSoap UV Disinfecting Wand due to excessive ultraviolet-C radiation emission. Approximately 6,700 units distributed nationwide may pose a radiation hazard to users.
Product
The product is a handheld ultraviolet-C germicidal wand and contains narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0743-2023·2022-12-28
HeartWare Model 1101 Implant: Hardened Driveline Cover May Delay Connector Access
The driveline cover on some HeartWare Model 1101 implanted pumps may harden over time, making it difficult to access the driveline connector. This could delay urgent maintenance, potentially causing patient harm.
Product
HeartWare Model 1101
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0739-2023·2022-12-28
Abbott Alinity m Resp-4-Plex Amp Kit Recalled for False Test Results
Abbott Molecular is recalling specific lots of the Alinity m Resp-4-Plex Amp Kit due to reports of false positive and false negative test results.
Product
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0089-2023·2022-12-28
Quinapril Tablets Recalled Due to Excess Impurity Above Limits
Lupin Pharmaceuticals is recalling Quinapril tablets (20 mg) due to N-nitroso-quinapril impurity detected above acceptable daily intake limits. The recall affects approximately 23,736 units distributed nationwide.
Product
QUINAPRIL — QUINAPRIL (QUINAPRIL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0741-2023·2022-12-28
InPen Diabetes App crashes, preventing dose reminders
The InPen Diabetes Management App may crash on certain Android versions, preventing dose reminders and potentially delaying insulin therapy. This could affect users of the diabetes management system.
Product
InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0200-2023·2022-12-28
Frozen Pizza Dough Recalled for Possible Foreign Object Contamination
It'll Be Pizza is recalling 22 oz Blonde, 20 oz Blonde EZ, and 24 oz Blonde EZ frozen pizza dough due to foreign object contamination from packaging. Products were distributed in Maine, Vermont, Massachusetts, Pennsylvania, and New Hampshire.
Product
22 oz Blonde; 20 oz Blonde EZ; 24 oz Blonde EZ frozen pizza dough manufactured by It'll Be Pizza
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-0730-2023·2022-12-28
GE B125P Patient Monitor CO2 Display May Show Inaccurate Readings at High Altitudes
GE is recalling B125P patient monitors because CO2 measurements may be inaccurate when used at non-sea-level altitudes in mmHg or kPa mode.
Product
B125P Patient Monitor (with E-module slot option), REF 6160000-002
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0085-2023·2022-12-28
Oxcarbazepine 600mg tablets recalled for foreign substance contamination
Sun Pharmaceutical is recalling three lots of Oxcarbazepine 600mg tablets due to the presence of foreign substances. The affected medication was distributed nationwide.
Product
OXCARBAZEPINE — OXCARBAZEPINE (OXCARBAZEPINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0724-2023·2022-12-28
DeVilbiss 525 Oxygen Concentrator Recalled Due to Excessive Heat
DeVilbiss is recalling the 525 oxygen concentrator because the device can become excessively hot, with external parts potentially exceeding 105.8 degrees Fahrenheit. The firm has updated the user manual to include additional safety warnings.
Product
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0731-2023·2022-12-28
GE B105M Patient Monitor displays inaccurate CO2 readings at altitude
GE Medical Systems is recalling B105M patient monitors that display inaccurate CO2 readings when used at elevations above sea level. The issue affects monitors showing CO2 in mmHg or kPa units.
Product
B105M Patient Monitor, REF 6160000-003
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0197-2023·2022-12-28
Frozen Pizza Dough Recalled for Foreign Object Contamination
It'll Be Pizza, LLC. is recalling EGA frozen pizza dough due to possible contamination with foreign objects from packaging debris. No illnesses have been reported.
Product
EGA 22 oz Pizza Dough Ball, 20 ct/ case; frozen pizza dough
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-0754-2023·2022-12-28
Vivid S5 N Ultrasound Systems Recalled for Potential Battery Fire Hazard
GE Medical Systems recalled 1,400 Vivid S5 N ultrasound systems for batteries that may fail, emit smoke, or catch fire if not replaced every 2 years as recommended.
Product
Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0207-2023·2022-12-28
Kerry flour-based breading recalled due to undeclared egg allergen
Kerry Inc is recalling flour-based breading products because the product contains egg allergen that is not declared on the label. The product was distributed to two customers in Mississippi.
Product
KERRY PRE IDQ 61-03 TND 50# 227262 300-121584, NET WEIGHT: 50 LB (22.68KG) INGREDIENTS: Bleached Enriched Wheat Flour***Bread Crumbs***Corn Syrup Solids, Dried Yeast, Soybean Oil, Salt, Mono and Diglycerides, Malted Barley Flour, Ammonium Sulfate, Leavening***Less Than 2%…
Category
Food
Distribution
1 state
HighFDA (Food)·F-0199-2023·2022-12-28
Frozen Pizza Dough Recalled for Potential Packaging Debris Contamination
It'll Be Pizza is recalling 24 oz frozen pizza dough distributed in five northeastern states due to possible contamination with foreign debris from packaging. Consumers should not consume affected products.
Product
24 oz Beer, frozen pizza dough manufactured by It'll Be Pizza
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-0727-2023·2022-12-28
Corin BIOLOX DELTA ceramic hip replacement heads mislabeled with incorrect sizes
Corin Ltd is recalling BIOLOX DELTA ceramic hip replacement heads because some units are labeled with incorrect sizes. The recall affects 12 units distributed in seven U.S. states.
Product
Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0204-2023·2022-12-28
King Oscar Anchovies Recalled for Elevated Histamine Levels
King Oscar Anchovies in Olive Oil are being recalled because they were found to contain elevated levels of histamine. The recall affects 263 cases distributed to wholesalers in Illinois and New Hampshire.
Product
King Oscar Anchovies Flat Fillet in Olive Oil 2 oz. can 18 cans per carton UPC number: 3480060061 Ingredients: Anchovies, Olive Oil, Salt. Packed in Peru Distributed by: Tri-Union Seafoods, LLC, El Segundo, CA 90245 USA
Category
Food
Distribution
3 states
HighNHTSA·22V953000·2022-12-23
2020-2023 Lincoln Aviator and Corsair Seat Belt Warning Chime Duration Defect
Ford is recalling certain 2020-2023 Lincoln Aviators and Corsairs because the seat belt warning chime may activate for less than 4 seconds, failing to properly alert unbelted drivers.
Product
LINCOLN — LINCOLN AVIATOR, CORSAIR
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22E101000·2022-12-23
Warn Industries Recalls Winch Remotes Due to Water Intrusion Risk
Warn Industries is recalling wireless winch remotes because water intrusion can cause corrosion, leading to unintentional winch operation and injury risk.
Product
EQUIPMENT:MECHANICAL:WINCH recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V951000·2022-12-22
Motorhomes recalled for faulty LPG service valves causing propane leak risk
Kibbi is recalling 2022–2023 Renegade Valencia motorhomes. Service valves on LPG tanks may be improperly connected, creating a propane leak risk that could lead to fire if an ignition source is present.
Product
RENEGADE RV — RENEGADE RV, RENEGADE VALENCIA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V950000·2022-12-22
2022 Acura TLX Tire Damage Recall Due to Bead Cuts and Tears
Honda is recalling approximately 19 model-year 2022 Acura TLX vehicles because their tires may have sustained cuts and tears. Damaged tires can lead to loss of vehicle control and increase crash risk.
Product
ACURA — ACURA TLX
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·23075·2022-12-22
GASGAS Off-Road Motorcycles Recalled for Engine Failure and Crash Hazards
KTM North America is recalling about 231 GASGAS MC 250 motorcycles due to an incorrectly programmed CDI box that can cause engine failure and pose crash and injury hazards. Consumers should stop riding the motorcycles immediately and contact an authorized dealer for a free repair.
Product
GASGAS Off-Road Motorcycles
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·23077·2022-12-22
Pacific 20-Inch Kids' Bicycles Recalled for Loose Handlebar Fall Hazard
Pacific Cycle is recalling about 147,000 Pacific Igniter and Pacific Bubble Pop 20-inch bicycles sold at Target because the handlebars can become loose during use, posing a fall hazard. Ten injuries involving bruising and abrasions have been reported.
Product
Pacific Igniter and Pacific Bubble Pop 20" kids' bicycles
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·23076·2022-12-22
BLU3 Nomad Battery-Powered Tankless Diving Systems Recalled for Drowning Hazard
BLU3 is recalling about 1,300 Nomad battery-powered tankless diving systems because the compressor head can fracture during use, restricting airflow and posing a drowning hazard to divers. No injuries have been reported.
Product
Nomad Battery-Powered Tankless Diving Systems
Category
Consumer Product
Distribution
Distributed nationwide