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.

14226–14250 of 22168

HighFDA (Drugs)·D-1138-2023·2023-09-06
dilTIAZem IV Bags Recalled Due to Lack of Sterilization Validation
Central Admixture Pharmacy Services is recalling 703 bags of dilTIAZem 125mg IV medication due to lack of validated sterilization processes. Healthcare providers and patients should verify lot numbers.
Product
dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1113-2023·2023-09-06
Rocuronium Injectable Drug Recalled Due to Sterility Assurance Failure
The FDA is recalling rocuronium injectable syringes due to unvalidated sterilization processes. The product was distributed nationwide.
Product
rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1462-2023·2023-09-06
Multiple Dressings and Dips Recalled for Improper Temperature Storage
C & S Wholesale Grocers recalled multiple brands of dressings and dips sold at Stop & Shop stores in New York, New Jersey, and Connecticut. Products were not held at appropriate temperatures and may pose a contamination risk.
Product
The following items sold at Stop & Shop stores located in the New York Metro Region: Bolthouse Avocado Goddess Dressing Bolthouse Blue Cheese Dressing Bolthouse Caesar Dressing Bolthouse Cucumber Ranch Dressing Marzetti Light Ranch Veg Dip Marzetti French Onion Veg Dip Marzetti
Category
Food
Distribution
3 states
HighFDA (Drugs)·D-1130-2023·2023-09-06
Epinephrine IV Bags Recalled Due to Lack of Sanitization Validation
Central Admixture Pharmacy Services is recalling epinephrine IV bags (Lot 36-260047) because sanitization processes lacked adequate validation data. The manufacturer cannot confirm the product meets sterility standards required for injectable medications.
Product
EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2499-2023·2023-09-06
Olympus Airway Mobilescope Recall Due to Connector Lodging Defect
Olympus is recalling 122 Airway Mobilescope units nationwide because the endoscope can become lodged in endotracheal tube connectors due to oversized diameter. Healthcare providers should immediately stop using affected devices.
Product
Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1461-2023·2023-09-06
Multiple Juice and Beverage Products Recalled for Improper Temperature Storage
C & S Wholesale Grocers Inc. is recalling 29,469 cases of various beverages sold at Stop & Shop stores in the New York Metro Region due to improper temperature storage that may have compromised product safety.
Product
The following items sold at Stop & Shop stores located in the New York Metro Region: Natures Promise Lemonade Natures Promise Orange Natures Promise Tangerine Harmless Harvest Coconut Water Organic Natalies Guava Lemonade Natalies Lemonade Natalies Guava Lemonade Natalies Strawb
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-2495-2023·2023-09-06
Olympus Airway Mobilescope models may become lodged in connectors
Olympus Airway Mobilescope endoscopes may become lodged in endotracheal tube connectors due to oversized diameter affecting airway management procedures nationwide.
Product
Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.
Category
Medical Device
Distribution
Distributed nationwide
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 (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 (Devices)·Z-2465-2023·2023-09-06
LifeSPARC Cardiac Pump Recalled Due to Uncured Epoxy Manufacturing Defect
Cardiac Assist, Inc. is recalling the LifeSPARC Pump due to uncured epoxy used during manufacturing that may cause early device failure. Two units were distributed in Illinois and Florida.
Product
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TAND
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1489-2023·2023-09-06
Mehlenbacher's Taffy Peanut Butter Cup Recalled for Undeclared Milk Allergen
Mehlenbacher's Taffy peanut butter cup pieces are recalled due to undeclared milk allergen. The product may pose a risk to consumers with milk allergies.
Product
Mehlenbacher's Taffy, 1.25 oz per piece, 36 pieces/box, cello wrapped. Peanut butter cup, UPC 022099174080. Storage in a cool dry place.
Category
Food
Distribution
0 states
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-1473-2023·2023-09-06
Moore Family Farms Cheddar Cheese Curds Recalled for Possible E. Coli Contamination
Moore Family Farms and Creamery is recalling Cheddar Cheese Curds Cucumber Dill because they may contain elevated coliform count and generic E. coli. Consumers should discard the product.
Product
Moore Family Farms and Creamery Cheddar Cheese Curds Cucumber Dill, 1 lb plastic bag.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2463-2023·2023-09-06
SurgiCount+ Surgical Sponge Counting Software Miscounting Recalled
Stryker Corporation is recalling the SurgiCount+ Software Application due to potential miscounting of surgical sponges when scanning multiple items from the same package. The software may fail to accurately track RFID-tagged absorbent articles.
Product
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;
Category
Medical Device
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 (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 (Devices)·Z-2494-2023·2023-09-06
Olympus Bronchovideoscope Recall Due to Device Lodging Risk
Olympus is recalling Bronchovideoscope Models BF-UC180F and BF-UC190F because the device diameter is too large and can become lodged in the endotracheal tube connector. Healthcare facilities should discontinue use and contact Olympus.
Product
Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1467-2023·2023-09-06
Dairy and Plant-Based Cheese Products Recalled for Improper Temperature Storage
C & S Wholesale Grocers Inc. is recalling cheese and dairy alternative products sold at Stop & Shop stores in the New York Metro Region because they were not held at appropriate temperatures. Consumers should discard or return affected items.
Product
The following items sold at Stop & Shop stores located in the New York Metro Region: Galaxy Parmeson Topping Vitro Vegan Cheddar Shreds Vitro Cheddar Block Vitros Cheddar Slices Vitros Mozz Shreds Vitros vegan Feta Galaxy Cheddar Veggie Sliced Mozzarella Field Roast Chao Sliced
Category
Food
Distribution
3 states
HighFDA (Drugs)·D-1128-2023·2023-09-06
Phenylephrine IV Injection Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls phenylephrine IV bags nationwide because the manufacturer lacks validated sanitization data to ensure sterility. Healthcare providers should identify and quarantine affected inventory.
Product
PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1112-2023·2023-09-06
Cardioplegia Solution Recalled for Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling 786 bags of Cardioplegia Solution del Nido Formula nationwide due to lack of validation data for sanitization cycles, which affects sterility assurance.
Product
Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Rx Only, Central Admixture Pharmac
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1131-2023·2023-09-06
EPINEPHrine IV bags recalled for sterility assurance failure
Central Admixture Pharmacy Services recalled 554 bags of EPINEPHrine added to dextrose 5% IV bags nationwide due to insufficient validation of sanitization procedures, creating a lack of sterility assurance.
Product
EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2477-2023·2023-09-06
FDA Recalls Siemens epoc BGEM Crea Test Cards for Inaccurate Glucose Results
Siemens Healthcare is recalling epoc BGEM Crea Test Cards that may produce inaccurate glucose readings in lower-range samples. 473 units were distributed to US facilities and international locations. No injuries reported.
Product
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Category
Medical Device
Distribution
26 states
HighFDA (Food)·F-1487-2023·2023-09-06
Mehlenbacher's Watermelon Taffy recalled for undeclared milk allergen
Mehlenbacher's Taffy in Watermelon flavor is being recalled due to undeclared milk allergen in the product. Consumers with milk allergies should not consume this product.
Product
Mehlenbacher's Taffy, 1.25 oz per piece, 36 pieces/box, cello wrapped. Watermelon UPC 022099174004. Storage in a cool dry place.
Category
Food
Distribution
0 states
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 (Food)·F-1463-2023·2023-09-06
Del Monte Canned Fruit Recall Due to Improper Temperature Storage
C & S Wholesale Grocers is recalling approximately 29,469 cases of Del Monte canned fruit products sold at Stop & Shop stores in NY, NJ, and CT because they were not held at appropriate temperatures during distribution.
Product
The following items sold at Stop & Shop stores located in the New York Metro Region: Del Monte Red Grapefruit Del Monte Citrus Salad Del Monte Grapefruit No sugar added Del Monte Pears Del Monte Blueberry Parfait Del Monte Mandarine Orange Del Monte Peaches No Sugar Added Del M
Category
Food
Distribution
3 states