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.

14251–14275 of 22168

HighFDA (Devices)·Z-2471-2023·2023-09-06
Laboratory diagnostic test may produce inaccurate results from reagent carryover
Siemens is recalling the Atellica CH Total Bilirubin diagnostic test because reagent carryover on the analyzer could produce falsely elevated results affecting multiple related lab tests.
Product
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1107-2023·2023-09-06
FDA Recalls Cardioplegia Solution Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 304 bags of cardioplegia solution nationwide due to lack of validation data for sterilization cycles.
Product
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2473-2023·2023-09-06
Diagnostic reagent kit recall: potential test result inaccuracy
Siemens is recalling Atellica CH diagnostic reagent kits due to potential reagent carryover that could produce inaccurate test results. This may affect quality control and patient test reliability.
Product
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2464-2023·2023-09-06
Oncology Software Allergy Warnings May Not Display for Medication Ingredients
RayCare oncology software versions 5A, 5B, and 6A may fail to display medication allergy warnings under certain circumstances. Healthcare facilities could inadvertently prescribe medications patients are allergic to.
Product
RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2468-2023·2023-09-06
Chevalier Valvulotome Surgical Instrument Recalled Due to Burr Defect
LeMaitre Vascular is recalling certain Chevalier Valvulotome surgical instruments used in vein-graft procedures due to burrs on the cutting tip that may tear the harvested vein. The recall affects 225 units distributed internationally.
Product
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an invert
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-1110-2023·2023-09-06
Cardioplegia Solution Recalled for Unvalidated Sterilization Process
Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of validated sterilization processes used during its manufacture.
Product
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1482-2023·2023-09-06
Asmus Seasonings Asian Spice Blend recalled due to undeclared sesame allergen
Asmus Seasoning, Inc. is recalling Asmus Seasonings Asian Spice Blend because the product contains undeclared sesame. Consumers with sesame allergies should not consume this product.
Product
Asmus Seasonings Asian Spice Blend 18oz clear plastic bottle, UPC 7 18122 95603 6, item number 233944, 12 bottle per wholesale case
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-1122-2023·2023-09-06
Neonatal TPN Nutrition Bags Recalled for Sterility Validation Deficiency
Central Admixture Pharmacy Services recalled 108 bags of neonatal TPN solution (Lot 36-260017, expires 8/19/2023) due to insufficient validation data for sterilization cycles. The product was distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1123-2023·2023-09-06
Cardioplegia Solution Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls Cardioplegia Solution due to lack of validation data for sanitization cycles, which cannot assure product sterility.
Product
CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1140-2023·2023-09-06
DIANEAL Low Calcium peritoneal dialysis solution recalled for potential sterility compromise
Baxter Healthcare is recalling DIANEAL Low Calcium With Dextrose peritoneal dialysis solution due to potential leaks from the Luer component that could compromise sterility. The FDA classified this as a Class II recall.
Product
DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1488-2023·2023-09-06
Mehlenbacher's Taffy strawberry lemonade recalled for undeclared milk allergen
Mehlenbacher's Taffy strawberry lemonade is being recalled due to an undeclared milk allergen. Consumers with milk allergies are at risk.
Product
Mehlenbacher's Taffy, 1.25 oz per piece, 36 pieces/box, cello wrapped. Strawberry lemonade UPC 022099174035. Storage in a cool dry place.
Category
Food
Distribution
0 states
HighFDA (Drugs)·D-1118-2023·2023-09-06
Neonatal TPN Starter Bags Recalled for Sterility Assurance Gaps
Central Admixture Pharmacy Services is recalling 140 bags of Neonatal TPN Starter Bag due to lack of validation data for sanitization cycles. The injectable nutrition product was distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1108-2023·2023-09-06
FDA Recalls Cardioplegia Solution Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 184 units of Cardioplegia Solution nationwide due to lack of validation data for sterilization cycles, which compromises sterility assurance in this injectable cardiac medication.
Product
CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1470-2023·2023-09-06
Peanut Butter Mellow Mallow Recalled for Undeclared Soy and Coconut Allergens
BURNING ACRE recalled Peanut Butter Mellow Mallow 7-ounce packages due to undeclared soy lecithin and coconut allergens. The affected product was distributed in Georgia and Tennessee.
Product
Peanut Butter Mellow Mallow packaged in 7oz cellophane wrappers.
Category
Food
Distribution
2 states
HighFDA (Food)·F-1485-2023·2023-09-06
GFS Harvest Valley Cranberry/Grape Juice Recalled Due to Bloating
Lyons Magnus LLC is recalling GFS Harvest Valley Cranberry/Grape Juice in 4 fl oz cups due to signs of bloating observed in the product. Consumers should not consume affected juice from batch codes 9213 and 1613.
Product
GFS Harvest Valley Cranberry/Grape Juice packaged in 4 fl oz opaque white plastic cup 96 cups per case
Category
Food
Distribution
13 states
HighFDA (Devices)·Z-2490-2023·2023-09-06
Olympus Bronchovideoscope models recalled for lodging risk in airway connectors
Olympus is recalling 1,715 Bronchovideoscope units across eight models due to a diameter defect that causes the device to lodge in the endotracheal tube connector.
Product
Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2474-2023·2023-09-06
Siemens Atellica CH diagnostic reagent carryover may cause false laboratory test results
Siemens has recalled 18,524 units of its Atellica CH HDL Cholesterol diagnostic device due to potential reagent carryover that could produce false test results in patient samples and quality control testing.
Product
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2501-2023·2023-09-06
Olympus Tracheal Intubation Fiberscope Recalled Due to Lodging Risk
Olympus Corporation recalls Tracheal Intubation Fiberscope Models LF-P and LF-V nationwide. The device can become lodged in the endotracheal tube connector due to oversized diameter.
Product
Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1115-2023·2023-09-06
Neonatal Intravenous Nutrition Bags Recalled for Insufficient Sterility Validation
Central Admixture Pharmacy Services recalled 40 bags of Neonatal TPN starter bags due to lack of validation data for sanitization cycles. This creates a potential sterility assurance gap for an intravenous medication used for newborns.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1137-2023·2023-09-06
Diltiazem IV Bag Recalled Due to Lack of Sterilization Assurance
Central Admixture Pharmacy Services is recalling 235 bags of diltiazem IV product due to lack of validation data for sanitization cycles. No illnesses have been reported.
Product
dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2487-2023·2023-09-06
Intra-Aortic Balloon Pumps Fiber Optic Sensor Input Failure Recalled
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps because users reported failure of the fiber optic sensor input when inserting the balloon connector. This could affect proper device operation.
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1136-2023·2023-09-06
Vancomycin Injectable Recalled for Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling vancomycin injections nationwide (477 bags, lots 36-262215 and 36-262216) due to lack of validation data for sanitization cycles, which prevents assurance of product sterility.
Product
vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1469-2023·2023-09-06
Mellow Mallow marshmallows recalled for undeclared soy and coconut allergens
Mellow Mallow marshmallows are being recalled due to undeclared soy lecithin and coconut allergens. Consumers with allergies to these ingredients should not consume the affected product.
Product
Mellow Mallow packaged in 7oz cellophane wrappers.
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-2482-2023·2023-09-06
Medical Device Recall: Oculus Pentacam AXL Wave Measurement Inaccuracy
Oculus Pentacam AXL Wave optical devices may have insufficient anti-reflective coating, potentially causing inaccurate axial length measurements used in eye surgery planning.
Product
Oculus Pentacam AXL Wave, Ref 70020, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2493-2023·2023-09-06
Olympus Bronchovideoscope Models Recalled for Endotracheal Tube Connector Lodging Risk
Olympus is recalling 3,652 bronchovideoscope units nationwide due to complaints that the endoscope diameter is too large, creating a risk the scope may become lodged in the endotracheal tube connector.
Product
Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.
Category
Medical Device
Distribution
Distributed nationwide