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.

18526–18550 of 50407

HighFDA (Food)·F-0222-2022·2021-12-08
Classic Irish Coffee Hint of Cocoa packets recalled for undeclared milk
Trail Toddy & Company LLC is recalling Classic Irish Coffee Hint of Cocoa packets because milk is not declared on the label, though the product contains dairy ingredients. The recall affects products distributed in Illinois, Montana, and Massachusetts.
Product
Classic Irish Coffee Hint of Cocoa, each packet weighs 1.09 oz (31g), 30 packets per case. UPC 8 60003 91545 5. This product is a blend of shelf-stable ingredients and contains no alcohol. The label is read in parts: "***Ingredients: CANE SUGAR, *CREAM POWDER, *COFFEE, COCOA…
Category
Food
Distribution
3 states
HighFDA (Food)·F-0223-2022·2021-12-08
Mocha Irish Coffee packets recalled for undeclared milk allergen
Trail Toddy & Company LLC is recalling Mocha Irish Coffee packets because milk is not declared on the label, though the product contains cream and dairy, creating a risk for consumers with milk allergies.
Product
Mocha Irish Coffee 66% Cocao, each packet weighs 1.41 oz (40g), 30 packets per case. UPC 8 60003 91547 9. The label is read in parts: "***Ingredients: CANE SUGAR, *CREAM POWDER, COCOA BEANS, COCOA BUTTER, *COFFEE, COCOA POWDER, MOLASSES, HONEY, VANILLA, SEA SALT, LOCUST BEAN…
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-0320-2022·2021-12-08
Boston Scientific Hurricane RX Dilation Balloons Recalled for Pressure Loss Defect
Boston Scientific is recalling specific lots of Hurricane RX Dilation Balloons due to a pinhole defect that causes pressure loss, resulting in prolonged endoscopic procedures. Affected devices are used for dilating strictures in the bile duct.
Product
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0322-2022·2021-12-08
Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect
Boston Scientific is recalling the Hurricane RX Dilation Balloon due to a pinhole defect causing pressure loss during endoscopic procedures. The defect may result in prolonged procedures and inability to effectively treat biliary strictures.
Product
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0238-2022·2021-12-08
Tastykake Jelly Krimpets recalled for potential metal fragments
Flowers Foods is recalling Tastykake Jelly Krimpets due to potential small metal fragments in an ingredient, as reported by a supplier. The recall affects 12oz and 3oz packages distributed across 37 US states.
Product
Tastykake Jelly Krimpets 12oz (6-2ct) UPC 0 25600 00228 5 & 3oz (3ct) UPC 0 25600 00025 0
Category
Food
Distribution
37 states
HighFDA (Food)·F-0256-2022·2021-12-08
HEB Satin White Layer Cake Mix Recalled for Metal Contamination
Puratos Corporation is recalling HEB Satin White Layer Cake in 50-pound bags due to possible contamination with metal foreign material. The affected product was distributed across multiple U.S. states and internationally.
Product
HEB Satin White Layer Cake Bag 50#. Material #4107393
Category
Food
Distribution
11 states
HighFDA (Devices)·Z-0330-2022·2021-12-08
Dimension Vista 1500 Diagnostic Device: Incorrect HIL Index Defaults
Siemens is recalling 1,407 Dimension Vista 1500 diagnostic devices worldwide due to incorrect default Hemolysis, Icterus, and Lipemia (HIL) index values affecting five assays.
Product
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0246-2022·2021-12-08
UV-C Germicidal Wand Recalled for Excessive Ultraviolet-C Radiation
MAX LUX CORP is recalling approximately 9900 handheld UV-C germicidal wands (Safe-T Lite) distributed nationwide due to excessive ultraviolet-C radiation emissions.
Product
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0242-2022·2021-12-08
Target Good & Gather Mixed Berry Sparkling Water Recall for Unlabeled Sulfites
Target Good & Gather Mixed Berry Sparkling Water in 8-packs is being recalled due to unlabeled sulfites. Keurig Dr Pepper discovered the issue after receiving complaints about off flavor and off aroma.
Product
Target Good & Gather Mixed Berry Sparkling Water 8 pack of 12 oz. cans UPC can: 0 85239 11516 9, UPC outer Carton (8 pack): 0 85239 11345 5
Category
Food
Distribution
Distributed nationwide
HighCPSC·22028·2021-12-08
GE Appliances Recalls Free-Standing and Slide-In Ranges for Tip-Over Hazard
GE Appliances is recalling approximately 132,000 free-standing and slide-in electric and gas ranges because they can tip over if a heavy object is placed on an open oven door and the anti-tip-over bracket is not securely installed, risking burn injuries.
Product
Free-Standing and Slide-In Electric and Gas Ranges
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-0255-2022·2021-12-08
Finesse Bag 25# Flour Product Recalled for Metal Contamination
Puratos Corporation is recalling Finesse Bag 25# (Material #4107218, Batch Number 10644766) because the product may be contaminated with metal fragments. The product was distributed domestically and internationally.
Product
Finesse Bag 25#. Material #4107218
Category
Food
Distribution
11 states
HighFDA (Devices)·Z-0326-2022·2021-12-08
Boston Scientific HURRICANE RX Dilation Balloon Recalled for Pressure Loss
Boston Scientific is recalling HURRICANE RX Dilation Balloons due to a pinhole defect that causes pressure loss during endoscopic procedures. The device may fail to maintain necessary pressure, potentially prolonging procedures.
Product
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0241-2022·2021-12-08
Target Good & Gather Coconut Pineapple Sparkling Water Recalled for Unlabeled Sulfites
Keurig Dr Pepper is recalling Target Good & Gather Coconut Pineapple Sparkling Water because some cans contain unlabeled sulfites. The affected products were distributed nationwide.
Product
Target Good & Gather Coconut Pineapple Sparkling Water 8 pack of 12 oz. cans UPC can: 0 85239 04059 1, UPC outer carton (8 pack): 0 85239 03833 8
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0312-2022·2021-12-08
Blood Culture Identification Test Recalled Due to False Positive Risk
BioFire Blood Culture Identification 2 (BCID2) diagnostic panels are being recalled due to increased risk of false positive Acinetobacter calcoaceticus-baumannii results caused by non-viable contamination in blood culture vials.
Product
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0328-2022·2021-12-08
Cholesterol test system recalled due to calibration failure
RANDOX CHOL cholesterol test system is recalled due to a calibration defect that causes quality control results to be flagged as out of range. This could result in inaccurate cholesterol measurements in patient samples.
Product
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0318-2022·2021-12-08
Blood collection devices recalled due to premature needle retraction
Magnolia Medical Technologies is recalling Steripath Gen2 Blood Collection Systems due to an uptick in complaints of premature needle retraction during blood collection.
Product
The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0239-2022·2021-12-08
7UP Zero Sugar Lemon Lime Soda Recalled for Unlabeled Sulfites
Keurig Dr Pepper is recalling 7UP Zero Sugar Lemon Lime Soda due to unlabeled sulfites detected after customer complaints about off flavor and aroma. The recall affects 9,152 cases distributed nationwide.
Product
7UP Zero Sugar Lemon Lime Soda 12 pack of 12 oz. can UPC Cardboard Wrap Code: 7800001181 UPC Can Code: 0780790
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0262-2022·2021-12-08
Shirley's Sugar Top Muffin Base Recalled for Metal Contamination
Puratos Corporation is recalling Shirley's Sugar Top Muffin Base (15,950 lbs) because the product may contain metal foreign material. The affected batches were distributed to customers in multiple U.S. states and internationally.
Product
Shirley's Sugar Top Muffin Bse MB Bag50#. Material #4107632
Category
Food
Distribution
11 states
HighFDA (Food)·F-0267-2022·2021-12-08
Teg Satin Choc Creme Cake contaminated with metal fragments
Puratos Corporation is recalling Teg Satin Choc Creme Cake (50 lb bags, Batch 10688839) due to possible contamination with metal. The product was distributed across multiple states and internationally.
Product
Teg Satin Choc Creme Cake Bag 50#. Material #4107220
Category
Food
Distribution
11 states
HighFDA (Food)·F-0232-2022·2021-12-08
Motts No Sugar Added Apple Sauce recalled for potential metal contamination
Motts LLP is recalling Motts No Sugar Added Apple Sauce 3.9 oz. cups because the product may contain metal fragments. Consumers should not consume the product and should contact Motts for more information.
Product
Motts No Sugar Added Apple Sauce - 3.9 oz.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0314-2022·2021-12-08
Orthopedic Implant Head Package Lid May Debond From Sealed Package
Howmedica Osteonics Corp. is recalling specific lots of the 28MM -4 LFIT V40 HEAD due to potential debonding of the outer Tyvek lid from the sealed package.
Product
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0317-2022·2021-12-08
HALYARD STERLING ZERO Nitrile Exam Gloves Recall for Discoloration and Loss of Elasticity
O&M Halyard is recalling HALYARD STERLING ZERO nitrile exam gloves in all sizes due to discoloration and loss of elasticity with aging, making the gloves difficult or impossible to don without tearing. Approximately 5.86 million gloves distributed worldwide are affected.
Product
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0309-2022·2021-12-08
NuStat Trauma Pad XR Hemafiber Recalled for Elevated Endotoxin Levels
Beeken Biomedical is recalling NuStat 8-by-12-inch Trauma Pad XR Hemafiber in a 5-pack because endotoxin levels exceeded allowable limits. The recall affects 15 units distributed in Missouri.
Product
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-0257-2022·2021-12-08
NSA Creme Cake Recall Due to Potential Metal Contamination
Puratos Corporation is recalling NSA Creme Cake in 50-pound bags due to potential metal contamination. The product may pose a choking or injury hazard.
Product
NSA Creme Cake Bag 50#. Material #4107591
Category
Food
Distribution
11 states
HighFDA (Devices)·Z-0308-2022·2021-12-08
Abbott HeartMate Touch System App may fail due to Bluetooth interference issue
The Abbott HeartMate Touch Communication System may experience temporary app failure when nearby Bluetooth devices attempt connections. Once properly connected, the system functions normally.
Product
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Category
Medical Device
Distribution
Distributed nationwide