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.

13826–13850 of 53090

HighFDA (Food)·F-0699-2023·2023-03-29
Sprouts Farmers Market Saltine Crackers recalled for potential peanut contamination
Sprouts Farmers Market is recalling Saltine Crackers Sea Salt Tops due to potential peanut contamination. Approximately 1,050 cases were distributed in Arizona, California, and Georgia.
Product
Sprouts Farmers Market Saltine Crackers Sea Salt Tops NET WT 16 OZ (1 LB) 454g UPC 646670310164 packaged in slug wrapper in a cardboard carton, 12 packages per case
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1279-2023·2023-03-29
Cardiosave IABP Pneumatic Interface Module Recalled for Performance Issue
Datascope Corp. recalls the Cardiosave IABP Pneumatic Interface Module due to a Safety Disk performance issue that may reduce balloon inflation. Ten specific units with identified serial numbers are affected.
Product
Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0648-2023·2023-03-29
Kirkland Signature Colombian cold brew coffee recalled for metal contamination
Berner Foods Inc. is recalling Kirkland Signature Colombian Cold Brew Coffee due to metal contamination in 231,071 cases distributed across 13 states. Consumers should stop using affected products.
Product
Kirkland Signature Colombian Cold Brew Coffee ready-to-drink, 12 fl oz in aluminum can, 12 cans per case
Category
Food
Distribution
13 states
HighFDA (Devices)·Z-1281-2023·2023-03-29
Raystation Treatment Planning System Collimator Angle Export Defect
Raystation radiation therapy planning software may not correctly export collimator angle settings when using the DICOM export function. In exported files, the collimator angle may be replaced with zero regardless of the user's selection.
Product
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0650-2023·2023-03-29
DG Health Sugar Free Daily Fiber Recalled for Missing Phenylalanine Warning
DG Health Sugar Free Daily Fiber is recalled for missing a required phenylalanine warning label. People with phenylketonuria (PKU) require this warning to safely use the product.
Product
DG Health brand Sugar Free Daily Fiber in 10 oz. plastic containers (UPC: 860005934294).
Category
Food
Distribution
47 states
HighNHTSA·23V211000·2023-03-29
BMW seats may not restrain occupants properly in crash
BMW is recalling certain 2019–2021 3-series and X3/X4 models because the seat frame may not have been welded properly to the seat rails, risking occupant injury in a crash.
Product
BMW — BMW X4, X3, 330I, M340I
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0639-2023·2023-03-29
Japanese Potato Yokan Candy Recalled for Undeclared Coconut
Kinjo Seika Potato Yokan confection is being recalled because coconut, a major allergen, was not declared on the label. Consumers with coconut allergies should not consume this product.
Product
Kinjo Seika Potato Yokan 130g UPC: 4901324017056 Made in Japan
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-1272-2023·2023-03-29
Disposable Patient Circuit with Precision Flow System recalled for excessive condensation
Vapotherm has recalled 5,869 Low Flow Disposable Patient Circuits for the Precision Flow System due to reports of excessive condensation that may lead to rainout.
Product
Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1277-2023·2023-03-29
Cardiosave Hybrid Intra-Aortic Balloon Pump Performance Issue Recall
Datascope Corp. is recalling specific Cardiosave Hybrid intra-aortic balloon pumps due to a Safety Disk performance issue that may reduce balloon inflation and therapeutic benefit.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0473-2023·2023-03-29
Daytrana Methylphenidate Transdermal Patches Recalled for Defective Delivery System
Noven Pharmaceuticals recalls Daytrana (methylphenidate) 30 mg transdermal patches nationwide due to defective delivery system components that fail shear specifications. Patients should contact their healthcare provider regarding medication alternatives.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0645-2023·2023-03-29
Russell Stover Sugar Free Peanut Butter Cups Recalled for Undeclared Tree Nuts
Russell Stover Sugar Free Peanut Butter Cups are being recalled for undeclared tree nuts (pecans) on the outer packaging. The mislabeling poses a risk to consumers with tree nut allergies.
Product
Russel Stover Sugar Free Peanut Butter Cups packaged in 2.4oz peg bag, containing individually wrapped pieces. UPC 077260096937
Category
Food
Distribution
17 states
HighFDA (Food)·F-0627-2023·2023-03-29
Alpha Rice Mushroom Rice Recalled for Undeclared Coconut Allergen
Onishi Foods Alpha Rice Mushroom Rice is recalled due to undeclared coconut allergen on the label. Consumers with coconut allergies should not consume this product.
Product
Onishi Foods Alpha Rice Mushroom Rice 100g UPC: 4970088140546 Made in Japan
Category
Food
Distribution
6 states
HighFDA (Drugs)·D-0471-2023·2023-03-29
Daytrana Methylphenidate Patches Recalled for Defective Transdermal Delivery System
Noven Pharmaceuticals is recalling specific lots of Daytrana (methylphenidate) transdermal patches due to a defective delivery system that is out of specification for shear. Affected lots are Lot 91956 (6/2023) and Lot 92475 (7/2023), distributed nationwide.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1266-2023·2023-03-29
Attune Revision Tibial Insert Recalled for Excessive Gamma Radiation Exposure
DePuy Orthopaedics is recalling 7 units of the Attune Revision Tibial Insert that received excess gamma radiation during manufacturing, which may degrade implant material properties.
Product
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0647-2023·2023-03-29
Butter Toffee Recalled for Undeclared Milk and Soy Allergens
Bruttles Gourmet Candies Butter Toffee products lack allergen warnings for milk and soy. Consumers with allergies should not consume these products.
Product
Butter Toffee, net wt. 16 oz, 6 units per case. Label declares: Butter Toffee, Butter, Sugar, Corn Syrup, Almonds, Vanilla, Salt. www.bruttles.com. Butter Toffee, net wt. 4oz., part of Medium Samplers package. Product is packaged in cello bag and labeled Butter Toffee. Label…
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0468-2023·2023-03-29
Prescription Drug Recall: Jardiance Empagliflozin 25 mg Label Mix-Up
Boehringer Ingelheim Pharmaceuticals is recalling Jardiance (Empagliflozin) 25 mg tablets due to a label mix-up affecting 69,375 bottles distributed nationwide.
Product
JARDIANCE — JARDIANCE (EMPAGLIFLOZIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1207-2023·2023-03-29
BD Pyxis Automated Medication Dispensing Systems Firmware Downgrade Recall
CareFusion recalls 7,914 units of BD Pyxis automated medication dispensing systems after firmware was inadvertently downgraded during installation, potentially causing drawer failures and medication delivery delays.
Product
BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0626-2023·2023-03-29
MEITO Alphabet Chocolate recalled for undeclared coconut allergen
MEITO Alphabet Chocolate 50g packages sold in multiple U.S. states and Canada were distributed with undeclared coconut allergen. Consumers with coconut allergies should not consume this product.
Product
MEITO Alphabet Chocolate 50g 50g UPC: 4902757130909 Made in Japan
Category
Food
Distribution
6 states
HighFDA (Food)·F-0646-2023·2023-03-29
BODYARMOR SportWater recalled for potential plastic pieces
BA Sports Nutrition is recalling BODYARMOR SportWater due to potential plastic pieces in the product. The recall affects approximately 21 million bottles distributed across 11 states.
Product
BODYARMOR SportWater 24/700mL; BODYARMOR SportWater 12/1Liter; BODYARMOR SportWater 24/20oz 6PK; BODYARMOR SportWater 2x6/1 Liter; BODYARMOR SportWater 15/700mL Club; BODYARMOR SportWater 15/1L Club
Category
Food
Distribution
11 states
HighNHTSA·23V214000·2023-03-29
2022 Volkswagen Taos Fuel Pump May Cause Engine Stall
Volkswagen is recalling certain 2022 Taos vehicles because the fuel delivery pump may break and cause a sudden engine stall, increasing the risk of a crash.
Product
VOLKSWAGEN — VOLKSWAGEN TAOS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1263-2023·2023-03-29
Orthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert
DePuy Orthopaedics recalls 7 units of Attune Revision LPS Tibial Inserts (Part 151760118, Lot JP6452) distributed worldwide due to excessive gamma radiation during manufacturing. This overage may result in material property changes.
Product
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1278-2023·2023-03-29
Cardiosave IABP Safety Disk Model 0202-00-0140 Recalled for Performance Defect
Datascope Corp. is recalling 669 Cardiosave IABP Safety Disks due to a performance defect that may reduce balloon inflation during cardiac support therapy. The affected devices may not provide adequate augmentation to patients requiring mechanical circulatory support.
Product
Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0644-2023·2023-03-29
Onishi Foods Alpha Rice Recalled for Undeclared Coconut Allergen
Onishi Foods Alpha Rice Matsutake Mushroom Rice is being recalled because the label does not declare coconut, a major allergen. The recall affects 733 units distributed in multiple US states and Canada.
Product
Onishi Foods Alpha Rice Matsutake Mushroom Rice 100g UPC: 4970088140331 Made in Japan
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-1276-2023·2023-03-29
Cardiosave Hybrid intra-aortic balloon pump safety disk defect may reduce therapy efficacy
Datascope's Cardiosave Hybrid intra-aortic balloon pump may have a faulty Safety Disk that reduces balloon inflation and cardiac augmentation. No injuries reported.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-65
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1265-2023·2023-03-29
Attune Revision Limb Preservation System Tibial Insert Recalled for Over-Irradiation
DePuy Orthopaedics is recalling 7 units of the Attune Revision Limb Preservation System Tibial Insert (Lot JP9022) that received higher than specified gamma radiation doses. The over-irradiation may cause changes to implant material properties.
Product
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
Category
Medical Device
Distribution
Distributed nationwide