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.

16626–16650 of 53124

HighFDA (Food)·F-1460-2022·2022-07-27
Grandma's Fudge Classic Truffle Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Grandma's Fudge Classic Truffle due to undeclared tree nuts (pecans, almonds, coconut, macadamia, walnuts). The product may pose a risk to individuals with tree nut allergies.
Product
Grandma's Fudge Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 11062 7. Ingredients: Dark chocolate (sugar, chocolate liquor processed with potassium carbonate, cocoa butter, milk fat [butter], sunflower lecithin & pure vanilla) honey, butter (pasteurized cream, salt)…
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1463-2022·2022-07-27
Truffle Recall: Undeclared Tree Nuts Present Allergen Risk
Queen Bee Gardens is recalling Midnight Gold Classic Truffles for potentially containing undeclared tree nuts, which pose a risk to allergic consumers. Distribution included Colorado, New Mexico, Wyoming, and nationwide online.
Product
Midnight Gold Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 11070 2. Ingredients: Dark chocolate, honey, butter (pasteurized cream, salt), cream, non-fat dry milk, whey, almonds, milk chocolate, natural flavor, salt, soda, agar, algin & lecithin.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1455-2022·2022-07-27
Recall: Cherry Classic Truffle Contains Undeclared Tree Nuts
Queen Bee Gardens recalled Cherry Classic Truffles (1.4 oz) due to undeclared tree nuts: pecans, almonds, coconut, macadamia nuts, and walnuts. Consumers with tree nut allergies should not consume this product.
Product
Cherry Classic Truffle. Net Wt. 1.4 oz. PLU Code: 788394 11015 3. Ingredients: Milk chocolate, honey, butter (pasteurized cream & salt), cream, cherries, pecans, non-fat dry milk, whey, agar, algin, lecithin, citric acid & natural flavor.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1482-2022·2022-07-27
Honey Caramels Recalled for Undeclared Tree Nut Allergens
Queen Bee Gardens recalls Honey Caramels Vanilla products that may contain undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts), which can harm consumers with allergies.
Product
Honey Caramels Vanilla. PLU Code: 788394 12332 0 Product available in 5.87 oz. bag, 1 lb. bag, 3 lb. bag, 6 lb. bag.
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1246-2022·2022-07-27
Atropine Sulfate Injection Recalled Nationwide for Sterility Assurance Failure
Nephron Sterile Compounding Center LLC is recalling Atropine Sulfate Injection pre-filled syringes nationwide due to lack of assurance of sterility affecting approximately 13,340 syringes.
Product
Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, 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 Street Extension, West Columbia, SC 29172, NDC: 69374-935-03
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1428-2022·2022-07-27
Spinal Fixation Device Removal Key Recalled Due to Potential Fracture Risk
Aesculap Implant Systems recalls ENNOVATE MIS REMOVALKEY SHORT due to fracture risk if removal key is not used at 90-degree angle. Affected units distributed in CA, CO, IL, MI, OH, and TX.
Product
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1470-2022·2022-07-27
Chocolate Candy Products Recalled Due to Undeclared Tree Nuts
Queen Bee Gardens is recalling English Toffee chocolate products that may contain undeclared tree nuts. Consumers with tree nut allergies should not consume these products.
Product
***English Toffee D/C Bites. PLU Code: 788394 10110 6. Ingredients: Honey, dark chocolate (sugar, chocolate liquor processed with potassium carbonate, cocoa butter, milk fat [butter], sunflower lecithin, pure vanilla), butter (pasteurized cream, salt), pecans, cream, dry milk…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1405-2022·2022-07-27
Surgical Coronal Bender May Deform Spinal Implants During Surgery
Aesculap's coronal rod benders used in spinal surgery may deform implants during use. A Class II recall affects 2 units in Colorado.
Product
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-1260-2022·2022-07-27
Ketamine HCl Injection Syringes Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling Ketamine HCl Injection pre-filled syringes due to lack of assurance of sterility. The recall affects 30,745 syringes distributed nationwide.
Product
Ketamine HCl Injection, USP 30 mg/3 mL (10 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: 69374-982-33
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1425-2022·2022-07-27
Sensis diagnostic tool software may fail to display vital signs
Siemens' Sensis diagnostic tool may lose communication and fail to display vital signs during initial patient exams or after inactivity. Software updates are required.
Product
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1497-2022·2022-07-27
Valentine Gift Box Recall Due to Undeclared Tree Nuts
Queen Bee Gardens is recalling Valentine Gift Box products that may contain undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts). Products were distributed through 10 retail locations in Colorado, New Mexico, Wyoming, and nationwide online.
Product
Valentine Gift Box. Net wt. 7.5 oz. PLU Code: 788394 17700 2.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1430-2022·2022-07-27
Revie Superfoods Acai Smoothie Recalled for Potential Norovirus
Revie Superfoods Acai Twist 201g smoothie is recalled due to potential norovirus contamination from IQF raspberries. The recall affects 57,960 units distributed in PA, CA, IL, and TX.
Product
Revie Superfoods Acai Twist 201g Ready-to-Blend Acai Tart Smoothie Made in Canada UPC 8 54681 00009 1 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
Category
Food
Distribution
4 states
HighFDA (Food)·F-1494-2022·2022-07-27
Queen Bee Gardens Chocolate Recall: Undeclared Tree Nuts
Queen Bee Gardens is recalling Honeymoon Gift Box chocolates that may contain undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts.
Product
Honeymoon Gift Box 12 pc., 9 oz. PLU Code: 788394 96108 3 Ingredients: Dark, Milk & White Chocolate with Pecans, Cashews & Almonds
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1257-2022·2022-07-27
HYDROmorphone Injection Recalled Due to Lack of Sterility Assurance
HYDROmorphone HCl Injection 30 mg/30 mL from Nephron Sterile Compounding Center LLC is being recalled nationwide due to lack of assured sterility. The recall affects 18,570 syringes across three lot numbers.
Product
HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 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: 69374-559-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1270-2022·2022-07-27
Neostigmine Methylsulfate Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The recall affects 59,520 syringes distributed nationwide.
Product
Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, 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: 69374-932-03
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1439-2022·2022-07-27
BD Connecta Plus3 infusion connector recalled for potential stopcock leakage
Becton Dickinson is recalling BD Connecta Plus3 White Blend infusion connectors (Lot 1127328) due to potential stopcock leakage. The defect may interrupt treatment, expose patients to biohazardous material, or cause under-infusion.
Product
BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1406-2022·2022-07-27
Spinal Surgery Instrument Recall: LEFT CORONAL BENDER May Deform Implants
Aesculap Implant Systems LLC is recalling the LEFT CORONAL BENDER (TEK1939) surgical instrument used in spinal procedures because it may deform implants when used with spinal system devices.
Product
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1414-2022·2022-07-27
Hill-Rom Hospital Mattress Surfaces Recalled for Pressure Ulcer Risk
Baxter Healthcare is recalling 202 Hill-Rom PRO+ mattress surfaces. The microclimate management feature may malfunction, reducing the product's ability to manage heat and moisture, which increases the risk of patient pressure ulcers.
Product
Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1438-2022·2022-07-27
Chuckanut Bay Cheesecake Bites Recalled for Undeclared Soy Allergen
Chuckanut Bay Foods LLC is recalling chocolate cheesecake bites because the label declares sunflower lecithin but the product contains undeclared soy lecithin, a major allergen. Consumers with soy allergies could experience allergic reactions.
Product
Item 34017-12, Chuckanut Bay Cheesecake Bites Chocolate. Perishable - Keep Refrigerated. There are 8 pieces per pack and 12 packs per case. Net wt. per pack 6.4 oz. UPC 6 03812 34017 5. Item 35017-12, Chocolate Cheesecake Bites. Edible brand. Distributed by Wish Foods, LLC.…
Category
Food
Distribution
13 states
HighFDA (Drugs)·D-1247-2022·2022-07-27
Bupivacaine Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 6900 syringes of Bupivacaine HCl Injection nationwide due to lack of sterility assurance. No illnesses or injuries have been reported.
Product
0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Ext., West Columbia, SC 29172, NDC: 69374-970-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1474-2022·2022-07-27
Honey Caramels Caramel Apple Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honey Caramels Caramel Apple because the product may contain undeclared tree nuts. The recall affects products sold at ten retail locations and online nationwide.
Product
Honey Caramels Caramel Apple. Net wt. 5.87 oz. PLU Code: 788394 12204 0. Ingredients: Honey, butter (pasteurized cream & salt), cream, almonds, nonfat dry milk, whey, natural flavors, lecithin, algin & agar.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1418-2022·2022-07-27
Genesis II Tibial Baseplate Devices Recalled for Packaging Error
Smith & Nephew recalled 31 Genesis II Tibial Baseplate devices that were mispackaged with contents not matching the outer box label. This could result in implanting the wrong-sized component during knee surgery.
Product
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1420-2022·2022-07-27
Ambu VivaSight 2 DLT endobronchial tubes recalled for cuff leak risk
Ambu Inc. is recalling the VivaSight 2 DLT endobronchial tube system due to reports of cuff leaks or ruptures that could compromise airway security during intubation procedures.
Product
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1245-2022·2022-07-27
Nephron Amino Acid Injection Bags Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 163 bags of Amino Acid Injection due to lack of assurance of sterility. Patients using this intravenous medication should contact their healthcare provider immediately.
Product
Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1259-2022·2022-07-27
Ketamine HCl Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Ketamine HCl Injection due to lack of sterility assurance. The recall affects 91,445 pre-filled syringes distributed nationwide.
Product
Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, 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: 69374-982-55
Category
Drug
Distribution
Distributed nationwide