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.

8001–8025 of 22104

HighFDA (Food)·F-0601-2025·2025-03-12
King Harvest Hummus Recalled for Plastic Fragment Contamination
Pacific Coast Fresh CO recalled King Harvest Toasted Onion Hummus for possible plastic fragments. Affected product was distributed in Idaho, Oregon, and Washington.
Product
Item #96524, King Harvest Toasted Onion Hummus, net wt. 10oz., UPC 025726 31129 2, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1293-2025·2025-03-12
Alcon Custom Pak surgical packs mislabeled as latex-free despite containing latex
Alcon surgical procedure packs contain latex but are labeled as latex-free, creating risk of allergic reaction for patients with latex sensitivity. The company is recalling 2,511 affected units.
Product
Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0602-2025·2025-03-12
Food Recall: Plastic Fragments in King Harvest Toasted Sesame Hummus
Pacific Coast Fresh CO is recalling King Harvest Toasted Sesame Hummus (10oz) due to plastic fragments. Affected products were distributed in Idaho, Oregon, and Washington with expiration dates from February 3 to 23, 2025.
Product
Item #96526 and item #32900, King Harvest Toasted Sesame Hummus, net wt. 10oz., UPC 025726 31122 3, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1249-2025·2025-03-12
Access Erythropoietin Reagent Lot Produces Falsely Decreased Test Results
Beckman Coulter's Access Erythropoietin (EPO) reagent lot 439363 produces falsely decreased test results with patient samples. Affected results may lead to improper diagnosis or unnecessary repeat testing.
Product
Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis) in mammals. Renal production of EPO is regulated by changes in oxygen availabil
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-1259-2025·2025-03-12
MiniMed Insulin Pumps Recalled for Abnormal Insulin Delivery During Flight
MiniMed insulin pumps may deliver abnormal insulin doses during aircraft takeoff and landing due to air pressure changes, risking severe blood sugar fluctuations, seizures, and potentially fatal complications.
Product
MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0256-2025·2025-03-12
Nelarabine prescription injection recalled due to failed quality specifications
Zydus Pharmaceuticals is recalling 1,893 vials of Nelarabine Injection (250 mg/50 mL) due to failed quality specifications for impurities and degradation. Patients should contact their healthcare provider about the recall.
Product
NELARABINE — NELARABINE (NELARABINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0595-2025·2025-03-12
Hummus Recall: Plastic Fragments in King Harvest Jalapeno Hummus
Pacific Coast Fresh Co is recalling 10,374 cups of King Harvest Jalapeno Hummus due to plastic fragments. The affected product was distributed in Idaho, Oregon, and Washington with expiration dates in February and March 2025.
Product
Item #96521, item #32896, and item #32898, King Harvest Jalapeno Hummus, net 10oz., UPC 025726 31004 2, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
Category
Food
Distribution
0 states
HighFDA (Food)·F-0599-2025·2025-03-12
Spinach hummus recalled for plastic fragment contamination
Pacific Coast Fresh Co is recalling King Harvest Spinach Hummus due to plastic fragment contamination. Affected products were distributed in Idaho, Oregon, and Washington with expiration dates in February 2025.
Product
Item #96527 and item #32902, King Harvest Spinach Hummus, net wt. 10oz., UPC 025726 31108 7, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
Category
Food
Distribution
0 states
HighFDA (Food)·F-0593-2025·2025-03-12
Hummus Recall: Plastic Fragments Found in King Harvest Chipotle Hummus
Pacific Coast Fresh CO is recalling 1953 cups of King Harvest Chipotle Hummus due to potential plastic fragments in the product. The affected hummus was distributed in Idaho, Oregon, and Washington.
Product
Item #96517, King Harvest Chipotle Hummus, net wt. 10oz., UPC 025726 31007 3, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1266-2025·2025-03-12
Medtronic MiniMed insulin pumps may deliver abnormal insulin doses during flight
Medtronic MiniMed insulin pumps may deliver abnormal doses of insulin during airplane takeoff or landing due to air pressure changes. This can result in severe hypoglycemia or hyperglycemia, with potential for seizure, coma, or death.
Product
MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1268-2025·2025-03-12
Heat Moisture Exchanger Connector Occlusion May Impair Ventilation
Kung Shin Plastics' CircuitGuard ThermoFlo Filter may have plastic obstructing the machine-side connector, preventing proper ventilation bag operation and risking oxygen deprivation during manual ventilation.
Product
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1294-2025·2025-03-12
Tissue Approximation System zip-ties at risk of breaking during implantation
TAS Medical is recalling Tissue Approximation System models because tissue approximation straps (zip-ties) may break before or during surgery. Undetected breaks could lead to hernia recurrence requiring additional corrective surgery.
Product
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1255-2025·2025-03-12
Medtronic Paradigm insulin pumps may deliver incorrect doses during flight
Medtronic MiniMed insulin pumps may deliver abnormally high or low insulin doses in response to air pressure changes during airplane takeoff and landing, potentially causing severe hypoglycemia or hyperglycemia.
Product
Paradigm REF: MMT-712 and MMT-715
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0254-2025·2025-03-12
Morphine Sulfate Oral Syringes Recalled for Defective Delivery System Leakage
Safecor Health is recalling Morphine Sulfate 5 mg oral syringes nationwide due to leakage in the delivery system following repackaging. No illnesses have been reported.
Product
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0598-2025·2025-03-12
King Harvest Roasted Garlic Hummus recalled for plastic fragment contamination
King Harvest Roasted Garlic Hummus is being recalled for possible plastic fragment contamination. The voluntary recall affects 9,588 cups distributed in Idaho, Oregon, and Washington.
Product
Item #96520 and item #32898, King Harvest Roasted Garlic Hummus, net wt. 10oz., UPC 025726 21114 1, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1267-2025·2025-03-12
MIM Radiological Imaging Software Versions May Generate Incorrect Diagnostic Values
MIM radiological software versions 7.2.0-7.2.6 may produce incorrect readings when fusing images with different fields of view, which could affect diagnostic accuracy.
Product
MIM software; System, Image Processing, Radiological
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·25V836000·2025-03-12
Volkswagen ID.4 recalled for high-voltage battery fire risk
Volkswagen is recalling approximately 629 2023-2024 ID.4 vehicles with defective high-voltage battery cell modules. Misaligned electrodes in the battery may cause fires, posing a risk of injury to vehicle occupants.
Product
VOLKSWAGEN — 2024 VOLKSWAGEN ID.4
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0253-2025·2025-03-12
Lorazepam Oral Syringes Recalled Due to Defective Delivery System Causing Leakage
Safecor Health, LLC is recalling Lorazepam 0.5 mg oral syringes nationwide due to a defective delivery system that causes leakage after repackaging.
Product
Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0592-2025·2025-03-12
King Harvest Black Olive Hummus Recalled Due to Plastic Fragments
King Harvest Black Olive Hummus (10 oz) has been recalled due to the presence of plastic fragments. The voluntary recall affects 4,019 cups distributed in Idaho, Oregon, and Washington.
Product
Item #96514 and item #32903, King Harvest Black Olive Hummus, net wt. 10oz., UPC 025726 31121 6, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1260-2025·2025-03-12
Medtronic MiniMed Insulin Pumps Recalled for Abnormal Delivery During Air Pressure Changes
Medtronic is recalling MiniMed insulin pumps that malfunction during airplane takeoff and landing due to air pressure changes. The defect can cause abnormal insulin delivery, leading to severe hypoglycemia, hyperglycemia, seizure, coma, or death.
Product
MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1270-2025·2025-03-12
Philips BGM 4 Blood Glucose Meter Battery Expansion Risk Recall
Telcare recalls 34,764 Philips BGM 4 blood glucose meters (Model TM0009) nationwide due to battery expansion and swelling. The battery may cause the back cover to separate or, in worst-case scenarios, explode. No injuries reported to date.
Product
Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0597-2025·2025-03-12
Roasted Pepper Hummus Recalled for Potential Plastic Fragment Contamination
Pacific Coast Fresh Co is recalling King Harvest Roasted Pepper Hummus due to potential plastic fragment contamination. The voluntary recall affects 9,535 units distributed in Idaho, Oregon, and Washington.
Product
Item #96525 and item #32897, King Harvest Roasted Pepper Hummus, net wt. 10oz., UPC 025726 31127 8, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
Category
Food
Distribution
0 states
HighFDA (Food)·F-0596-2025·2025-03-12
King Harvest Lemon Hummus Recalled for Plastic Fragment Contamination
King Harvest Lemon Hummus (10 oz) is being recalled due to possible plastic fragments in the product. The voluntary recall affects approximately 2,084 cups distributed in Idaho, Oregon, and Washington.
Product
Item #96522, King Harvest Lemon Hummus, net wt. 10oz., UPC 025726 31001 1, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
Category
Food
Distribution
0 states
HighFDA (Food)·F-0600-2025·2025-03-12
Food Recall: King Harvest Sundried Tomato Hummus, Plastic Fragments
Pacific Coast Fresh Co is recalling King Harvest Sundried Tomato Hummus due to potential plastic fragment contamination. The product was distributed in Idaho, Oregon, and Washington.
Product
Item #96528 and 32899, King Harvest Sundried Tomato Hummus, net wt. 10oz., UPC 025726 31118 6, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1258-2025·2025-03-12
MiniMed Insulin Pumps Recalled for Abnormal Delivery During Air Travel
Medtronic recalled MiniMed insulin pumps due to abnormal delivery caused by air pressure changes during airplane flights. The defect can cause severe hypoglycemia or hyperglycemia, potentially leading to seizure, coma, or death.
Product
MiniMed insulin pump, REF: 620G (MMT-1750)
Category
Medical Device
Distribution
Distributed nationwide