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.

16651–16675 of 53124

HighFDA (Food)·F-1478-2022·2022-07-27
Honey caramels recalled for undeclared tree nut allergen
Queen Bee Gardens is recalling Honey Caramels The Mint due to undeclared tree nuts. The product may contain pecans, almonds, coconut, macadamia nuts, or walnuts.
Product
Honey Caramels The Mint. Net wt. 5.87 oz. PLU Code: 788394 12760 1. Ingredients: Honey, butter (pasteurized cream & salt), cream, nonfat dry milk, whey, 100% pure essential peppermint oil, lecithin, algin & agar.
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1266-2022·2022-07-27
Morphine Sulfate Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Morphine Sulfate Injection due to lack of assurance of sterility. The recall affects 8,985 syringes distributed nationwide.
Product
Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1254-2022·2022-07-27
Glycopyrrolate Syringes Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 3450 glycopyrrolate injection syringes (NDC 69374-903-30, Lot GL2004A) nationwide due to lack of assurance of sterility.
Product
Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1410-2022·2022-07-27
Modulift VBR Surgical Screwdriver Fails Due to Tip Deformation
Aesculap is recalling the Modulift VBR 4MM set screwdriver due to tip deformation during surgical engagement with implants. The device is distributed in CA, FL, GA, IL, OH, and MI.
Product
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Category
Medical Device
Distribution
6 states
HighFDA (Food)·F-1439-2022·2022-07-27
Chuckanut Bay Cheesecake Bites Recalled for Undeclared Soy Lecithin
Chuckanut Bay Foods recalls cheesecake bites for undeclared soy lecithin in the chocolate compound. The label incorrectly states sunflower lecithin, creating an allergic reaction risk for consumers with soy allergies.
Product
Item 34021-12, Chuckanut Bay Cheesecake Bites Berry. Perishable - Keep Refrigerated. There are 8 pieces per pack and 12 packs per case. Net Wt. 6.4 oz. UPC 6 03812 34021 2. Item 35009-12, Chocolate Covered Berry Cheesecake Bites. Edible brand. Distributed by Wish Foods…
Category
Food
Distribution
13 states
HighFDA (Devices)·Z-1388-2022·2022-07-27
Hobbs Medical Polypectomy Snare May Fail to Close Properly
Hobbs Medical Polypectomy Snares (Catalog No. 7202) may accordion at the proximal end, preventing full closure and potentially causing injury. Specific lots distributed to medical facilities in NC, TX, WA, and Canada are affected.
Product
Hobbs Medical Polypectomy Snare, Catalog No. 7202
Category
Medical Device
Distribution
3 states
HighFDA (Food)·F-1447-2022·2022-07-27
Chuckanut Bay Cheesecake Bites recalled for undeclared soy allergen
Chuckanut Bay Foods is recalling Dipped Cheesecake Bites (Pumpkin) because the product contains undeclared soy lecithin. The label incorrectly lists sunflower lecithin, creating a health risk for consumers with soy allergies.
Product
Item 39408-12, Chuckanut Bay DIPPED CHEESECAKE BITES Pumpkin. Perishable - Keep Refrigerated. There are 4 pieces per pack and 12 packs per case. Net wt. 3.2 oz per package. UPC 6 03812 39408 6. The label is read in parts: "***INGREDIENTS: CREAM CHEESE***, PUMPKIN, CANE…
Category
Food
Distribution
13 states
HighFDA (Food)·F-1485-2022·2022-07-27
Honeymoons Milk Chocolate Cashew recalled for undeclared tree nuts
Queen Bee Gardens is recalling Honeymoons Milk Chocolate Cashew candy due to undeclared tree nuts including pecans, almonds, coconut, macadamia, and walnuts. Consumers with tree nut allergies face potential serious health risks.
Product
Honeymoons Milk Chocolate Cashew. PLU Code: 788394 14828 6
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1415-2022·2022-07-27
Medical Bed Mattress Microclimate Failure Increases Pressure Ulcer Risk
Affected Hill-Rom Centrella Pro+ hospital mattresses can fail to properly manage heat and moisture removal, increasing the risk of pressure ulcer development in patients.
Product
Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1255-2022·2022-07-27
HYDROmorphone Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center recalled 22,805 pre-filled syringes of HYDROmorphone HCl Injection due to lack of sterility assurance. Six lot numbers were distributed nationwide.
Product
HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-529-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1457-2022·2022-07-27
Dark chocolate truffles recalled for undeclared tree nut allergens
Queen Bee Gardens is recalling Dark Mint Classic Truffles for undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. Products were distributed to retail locations in CO, NM, WY and nationwide online.
Product
Dark Mint Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 11035 1. Ingredients: Dark chocolate, honey, butter (pasteurized cream & salt), cream, dry milk, whey, agar, algin, lecithin & peppermint oil. Decoration: "Ivory" chocolate & artificial color.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1471-2022·2022-07-27
Honey Caramels Almond Coconut Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honey Caramels Almond Coconut due to potential presence of undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts). Consumers allergic to tree nuts should not consume this product.
Product
Honey Caramels Almond Coconut. Product available in 5.87 oz. bag, 1 lb. bag, 3 lb. bag, 6 lb. bag. PLU Code for 5.87 oz bag: 788394 12004 6. Ingredients: Honey, butter (pasteurized cream & salt), cream, almonds, coconut, nonfat dry milk, whey, natural flavors, lecithin…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1452-2022·2022-07-27
SurgiCount+ System software error bypasses sponge tracking alerts
A software error in SurgiCount+ System Application may allow duplicate surgical sponges to be counted without the required documentation prompt. This could allow surgical cases to close without proper verification that all sponges were accounted for.
Product
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1408-2022·2022-07-27
Nonsterile convenience kit recall due to sterile component mislabeling
ROi CPS LLC is recalling 40 nonsterile convenience kits (Lot #92605) because sterile components were incorrectly packaged as nonsterile. The affected kits were distributed in Missouri.
Product
Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1424-2022·2022-07-27
Randox Cholesterol In Vitro Diagnostic Kits Fail Stated Performance Specifications
Randox Cholesterol diagnostic kits fail to meet stated performance specifications. Calibration issues cause quality control results to fall outside acceptable ranges, potentially delaying test results.
Product
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1487-2022·2022-07-27
Chocolate Cashew Candy Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honeymoons Ivory Chocolate Cashew candy because it may contain undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts, which can cause severe allergic reactions.
Product
Honeymoons Ivory Chocolate Cashew. PLU Code: 788394 14900 9
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1461-2022·2022-07-27
Queen Bee Gardens Huckleberry Truffles Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Huckleberry Truffles because they may contain undeclared tree nuts (pecans, almonds, coconut, macadamia, walnuts). Products were sold at retail locations in Colorado, New Mexico, Wyoming, and nationwide via internet.
Product
Huckleberry Truffle. Net wt. 1.4 oz. PLU Code: 788394 11057 3. Ingredients: Dark chocolate (sugar, chocolate liquor processed with potassium carbonate, cocoa butter, milk fat [butter], HONEY, "Ivory" chocolate (sugar, cocoa butter, whole & non-fat milk solids, sunflower…
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1264-2022·2022-07-27
Lidocaine HCl injection syringes recalled due to sterility assurance failure
Nephron Sterile Compounding Center has recalled 37,310 syringes of Lidocaine HCl Injection USP 1% nationwide due to lack of assurance of sterility. Affected lots expire between August and October 2022.
Product
Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-985-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1409-2022·2022-07-27
Aesculap Aeos Digital Microscope robotic arm malfunction requires system restart
Aesculap Implant Systems is recalling the UR5 robotic arm component in its Aeos Digital Microscope System due to malfunction that prevents arm movement and requires system restart.
Product
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-1444-2022·2022-07-27
Cheesecake Bite Products Recalled for Undeclared Soy Allergen Mislabeling
Chuckanut Bay Foods LLC is recalling cheesecake bite products with labels declaring sunflower lecithin when they actually contain soy lecithin. Soy is a major allergen not properly disclosed to consumers.
Product
Item 35001-12, Chocolate Covered CHEESECAKE BITES NY SIGNATURE. Edible brand. Distributed by Wish Foods, LLC. Perishable - Keep Refrigerated. There are 8 pieces per pack and 12 packs per case. Net Wt. 6.4 oz. UPC 8 50014 91804 0. Item 39401-12, Chuckanut Bay DIPPED…
Category
Food
Distribution
13 states
HighFDA (Food)·F-1464-2022·2022-07-27
Bee Energy Bar recalled due to undeclared tree nuts
Queen Bee Gardens is recalling Bee Energy Bars due to undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. Consumers with tree nut allergies should not consume this product.
Product
Bee Energy Bar. Net wt. 1.5 oz. PLU Code: 788394 18559 5. Ingredients: Dark chocolate (sugar, chocolate liquor, cocoa butter, milk fat [butter], sunflower lecithin, pure vanilla), honey, almonds, butter (pasteurized cream, salt), coconut, gluten free oats, dried…
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1436-2022·2022-07-27
Chuckanut Bay Cheesecake Bites Recalled for Undeclared Soy Lecithin
Chuckanut Bay Foods is recalling Cheesecake Bites that contain undeclared soy lecithin, listed on the label as sunflower lecithin. Consumers with soy allergies may face serious risk.
Product
Item 38180-12, Chuckanut Bay Cheesecake Bites New York + Chocolate. Perishable - Keep Refrigerated. There are 8 pieces per plastic clamshell pack and 12 packs per case. Net wt. per pack 6.4 oz. UPC 6 03812 38180 2. The label is read in parts: "***INGREDIENTS: CREAM…
Category
Food
Distribution
13 states
HighNHTSA·22V532000·2022-07-22
Thomas Built Buses Minotour Recalled for Incorrect Tire Labeling
Daimler Trucks North America is recalling 2019-2023 Thomas Built Buses Minotour school buses because tire labels list the wrong size, potentially affecting vehicle stability.
Product
THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR SRW
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V534000·2022-07-22
Monroe Towmaster Recalls Trailers With Incorrect Tire Load Ratings
Monroe Towmaster is recalling 2021-2022 TC-14D, T-24, and TC-24 trailers because installed tires have a lower load rating than required, increasing the risk of tire failure and crashes.
Product
TOWMASTER — TOWMASTER TC-14D, TC-24, T-24
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V533000·2022-07-22
Mercedes-Benz AMG vehicles: transmission wiring fire hazard, 2019-2022
Mercedes-Benz has recalled certain 2019–2022 AMG vehicles (CLS53, E53, GT53, and GT43 models) due to transmission wiring harness misrouting that can expose electrical connectors to corrosion, creating a fire risk.
Product
MERCEDES-BENZ — MERCEDES-BENZ AMG GT53, AMG E53, AMG CLS53, AMG GT43
Category
Vehicle
Distribution
Distributed nationwide