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.

12576–12600 of 53082

HighFDA (Drugs)·D-0903-2023·2023-07-19
Allergy Relief Fexofenadine Hydrochloride Tablets Recalled for Failed Quality Specifications
CVS Pharmacy is recalling 16,200 cartons of Allergy Relief fexofenadine hydrochloride tablets nationwide due to failed impurities and degradation specifications. Stop using affected lot 2DV1925 and consult a pharmacist.
Product
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1246-2023·2023-07-19
Protein supplement powder recalled for potential Staphylococcus aureus contamination
1st Phorm Level-1 protein supplement (Chocolate Marshmallow) is recalled because it may contain Staphylococcus aureus, a bacterium that can cause serious foodborne illness.
Product
1st phorm Level-1 Sustained Assimilation Protein. Chocolate Marshmallow. Protein Supplement. Item number 502396. Net Wt. 2.45 lbs (1.11kg) UPC 8 50036-64808 6. Manufactured & Designed Exclusively for 1st Phorm, 2091 Fenton Logistics Pk Blvd, Fenton, MO 63026
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0908-2023·2023-07-19
Fexofenadine Hydrochloride Tablets Recalled for Failed Quality Specifications
L. Perrigo is recalling 32,376 cartons of Good Sense Aller Ease antihistamine tablets nationwide due to failed quality specifications affecting impurities and degradation. Consult your healthcare provider if you have taken this product.
Product
GOOD SENSE ALLER EASE — GOOD SENSE ALLER EASE (FEXOFENADINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2133-2023·2023-07-19
Medline Non-Sterile PVP Solution Kits Mislabeled as Sterile
Medline is recalling Total Knee Theda surgical kits where the non-sterile PVP solution was mislabeled as sterile. Healthcare providers should immediately stop using the recalled kits and contact Medline.
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2134-2023·2023-07-19
Medline Non-Sterile PVP Solution Mislabeled as Sterile
Medline Industries is recalling 128 units of non-sterile PVP solution incorrectly labeled as sterile. Using a non-sterile product in sterile contexts could create infection risk.
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2107-2023·2023-07-19
Orthopedic Screw Recall Due to Undersized Head in Surgical Device
Osteomed is recalling orthopedic screws with undersized heads that may pass through bone plates. Affected lot numbers were distributed nationwide in the US and Singapore.
Product
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2125-2023·2023-07-19
GE Healthcare Vivid S70 ultrasound systems fail to boot timely
GE Healthcare Vivid S70 ultrasound devices may experience delayed startup. This can reduce equipment availability during time-critical emergency situations.
Product
GE Healthcare Vivid S70, ultrasound device
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0920-2023·2023-07-19
EzriCare Artificial Tears Eye Drops Recalled for Manufacturing Contamination
EzriCare Artificial Tears eye drops are being recalled nationwide due to manufacturing facility contamination and CGMP deviations. The recall includes multiple lot numbers distributed nationwide.
Product
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2128-2023·2023-07-19
Abiomed Introducer Set Recall Due to Sidearm Detachment Risk
Abiomed 14Fr Low Profile Introducer Sets are being recalled due to silicone oil contamination that may cause sidearm detachment during use. One detachment has been documented; no injuries have been reported.
Product
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0902-2023·2023-07-19
Careone Allergy Relief tablets recalled for failed impurity and degradation specifications
Careone Allergy Relief fexofenadine hydrochloride 180mg tablets are recalled nationwide for failing impurity and degradation specifications. Lot 2JE2185 with expiration date 01/24 is affected.
Product
CAREONE ALLERGY RELIEF — CAREONE ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1245-2023·2023-07-19
Tampico Brand Mango Punch Recalled for Undeclared Yellow 5 Dye
Tampico brand Mango Punch (1 gallon) is recalled because it contains undeclared Yellow 5, a food dye that can cause reactions in people with tartrazine sensitivity.
Product
Tampico brand Mango Punch; LESS THAN 1% JUICE; 1 GAL (3.78 L); INGREDIENTS: WATER, HIGH FRUCTOSE CORN SYRUP, LESS THAN 2% OF MANGO JUICE FROM CONCENTRATE, ORANGE JUICE FROM CONCENTRATE, TANGERINE JUICE FROM CONCENTRATE, ASCORBIC ACID (VITAMIN C), NATURAL AND ARTIFICIAL FLAVORS…
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-2123-2023·2023-07-19
Medtronic Catalyft LS Spinal Implant Recalled for Out-of-Specification Geometry
Medtronic recalls Catalyft LS spinal implants due to potential out-of-specification dimensions. The affected devices may not properly fit or function as intended during spine fusion surgery.
Product
Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0909-2023·2023-07-19
Allergy Relief Fexofenadine Tablets Recalled for Failed Impurity Specifications
L. Perrigo's Allergy Relief 180 mg tablets are being recalled due to failed impurity and degradation specifications. The recall affects 32,904 cartons distributed nationwide.
Product
ALLERGY RELIEF — ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2126-2023·2023-07-19
GE Healthcare Vivid S60N ultrasound devices experience boot-up delays
GE Healthcare Vivid S60N ultrasound systems may fail to boot in a timely manner. This can delay device availability during time-critical emergency situations.
Product
GE Healthcare Vivid S60N, ultrasound device
Category
Medical Device
Distribution
0 states
HighNHTSA·23V495000·2023-07-18
Titan Bus Recalls 2017-2021 Models for Missing Mirror Warning Label
Titan Bus is recalling 2017-2021 SRW and DRW school buses because a warning label may be missing from the Cross View Mirror, potentially increasing crash risk.
Product
TITAN BUS — TITAN BUS SRW, DRW
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V496000·2023-07-18
2021 Nissan Kicks vehicles recalled for power steering defect
Nissan is recalling 2021 Kicks vehicles due to an intermittent electrical connection in the power steering system that can disable power steering assist. Loss of power steering increases steering effort and crash risk.
Product
NISSAN — NISSAN KICKS, VERSA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23E054000·2023-07-18
Cummins Recalls B6.7 Diesel Engines Due to Lifting Bracket Bolt Issue
Cummins is recalling certain B6.7 diesel engines because an insufficiently tightened bolt may cause the rear lifting bracket to detach, increasing injury risk during lifting.
Product
ENGINE AND ENGINE COOLING:ENGINE:DIESEL recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V494000·2023-07-17
2018-2023 Nissan Leaf vehicles recalled for unintentional acceleration risk
Nissan is recalling certain 2018-2023 Leaf vehicles that may accelerate unintentionally when the driving mode is changed after disengaging cruise control. The defect increases the risk of crashes.
Product
NISSAN — NISSAN LEAF
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V493000·2023-07-17
Pleasure Way motorhomes recalled for fuel hose fire risk
Pleasure Way is recalling certain 2021-2023 OnTour and Lexor motorhomes due to fuel hose defects that may cause gasoline leaks and fire risk. Dealers will inspect and replace fuel hoses free of charge.
Product
PLEASURE WAY — PLEASURE WAY ONTOUR, LEXOR
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V490000·2023-07-17
Grand Design RV Recall: Improperly Tightened Suspension U-Bolts
Grand Design is recalling certain 2021–2024 Solitude and Momentum fifth wheels with improperly tightened suspension U-bolts. Loose U-bolts can cause the axle to move, leading to loss of vehicle control.
Product
GRAND DESIGN — GRAND DESIGN MOMENTUM, SOLITUDE
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V489000·2023-07-14
Tesla Recalls 2023 Model S, X, and Y for Camera Misalignment
Tesla is recalling 2023 Model S, X, and Y vehicles because a misaligned forward-facing camera may disable active safety features without warning, increasing crash risk.
Product
TESLA — TESLA MODEL Y, MODEL S, MODEL X
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V487000·2023-07-14
Mazda recalls 2014-2018 Mazda3 and CX-3 for faulty rearview cameras
Mazda is recalling 2014-2018 Mazda3 and 2016-2021 CX-3 vehicles because rearview cameras may display flickering or distorted images, reducing visibility and increasing crash risk. Dealers will inspect and replace cameras free of charge.
Product
MAZDA — MAZDA MAZDA3, CX-3
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V488000·2023-07-14
Tesla Model S and Model X seat belts may detach in crash
Tesla is recalling certain 2021-2023 Model S and Model X vehicles because front-row seat belts may not be connected properly to pretensioner anchors and could detach. A detached seat belt may fail to properly restrain an occupant during a crash.
Product
TESLA — TESLA MODEL S, MODEL X
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V486000·2023-07-14
Motorhomes: Overheating HVAC Wiring Could Cause Fires in Entegra, Jayco Models
Certain 2020-2021 Entegra and Jayco motorhomes are recalled because inadequate HVAC blower motor circuit wiring can overheat, increasing fire risk. The remedy involves relocating and replacing the fuse and wiring harness.
Product
ENTEGRA — ENTEGRA, JAYCO LAUNCH, MELBOURNE PRESTIGE, MELBOURNE, QWEST
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·23243·2023-07-13
Gas-Fired Residential Boilers Recalled for Carbon Monoxide Exposure Risk
ECR International is recalling about 1,745 gas-fired hot water residential boilers that may be missing a flue inspection cover plate, which can expose residents to combustion flue gases and carbon monoxide poisoning.
Product
Gas-fired hot water residential boilers
Category
Consumer Product
Distribution
Distributed nationwide