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.

16576–16600 of 53124

HighFDA (Food)·F-1462-2022·2022-07-27
Macadamia Classic Truffles Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Macadamia Classic Truffles because they may contain undeclared tree nuts including almonds, coconut, and walnuts. The product poses allergen risks to consumers with tree nut allergies.
Product
Macadamia Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 11060 3. Ingredients: Milk chocolate (sugar, milk, cocoa butter, chocolate liquor, soya lecithin and pure vanilla) honey, butter (pasteurized cream, salt), cream, roasted & sea salted macadamias, pecans, non-fat dry…
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1273-2022·2022-07-27
Oxytocin Injectable Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Oxytocin 30 Units/500 mL injectable solution due to lack of sterility assurance. Approximately 1,810 bags with lot codes OX2013C and OX2013E were distributed nationwide.
Product
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-543-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1450-2022·2022-07-27
Chocolate Cheesecake Bites Recalled for Undeclared Soy Lecithin
Chuckanut Bay Foods is recalling Chocolate Cheesecake Bites because the label lists Sunflower Lecithin when the product actually contains Soy Lecithin, an undeclared allergen. Consumers with soy allergies face a potential health risk.
Product
Item 32017-56, Chocolate Cheesecake Bites BULK. Perishable - Keep Refrigerated. There are 14 pieces per pack and 56 packs per case. Firm did not provide label.
Category
Food
Distribution
13 states
HighNHTSA·22V541000·2022-07-27
2022-2023 BMW IX and i4 High-Voltage Battery Fire Risk Recall
Certain 2022-2023 BMW IX and 2022 i4 vehicles are recalled due to high-voltage batteries that may develop internal damage and short-circuit, posing a fire risk. Owners should not drive or charge the vehicle until the battery is replaced.
Product
BMW — BMW IX, I4
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-1451-2022·2022-07-27
Almond Coconut Truffles Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Almond Coconut Classic Truffles for undeclared tree nuts (pecans, almonds, coconut, macadamia, walnuts). The affected product was sold in Colorado, New Mexico, Wyoming, and nationwide online.
Product
Almond Coconut Classic Truffle. Net Wt. 1.4 oz. PLU Code: 788394 11025 2. Ingredients: Milk & dark chocolate, honey, butter (pasteurized cream & salt), cream, coconut, almonds, non-fat dry milk, whey, natural flavors, agar, algin & lecithin. Note: Typo on website should be…
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1445-2022·2022-07-27
Chuckanut Bay Cheesecake Bites Recalled for Undeclared Soy Lecithin
Chuckanut Bay Foods is recalling Dipped Cheesecake Bites Chocolate because the product label lists Sunflower Lecithin when it actually contains undeclared Soy Lecithin, a potential allergen.
Product
Item 39417-12, Chuckanut Bay DIPPED CHEESECAKE BITES Chocolate. Perishable - Keep Refrigerated. There are 4 pieces per pack and 12 packs per case. Net Wt. 3.2 oz. per package. UPC 6 03812 39417 8. The label is read in parts: "***INGREDIENTS: CREAM CHEESE***, CANE SUGAR…
Category
Food
Distribution
13 states
HighFDA (Food)·F-1440-2022·2022-07-27
Chuckanut Bay Chocolate Covered Cheesecake Bites Recalled for Undeclared Soy Allergen
Chuckanut Bay Foods is recalling 18 cases of Chocolate Covered Coconut Cheesecake Bites due to undeclared soy lecithin. The product contains soy lecithin but is labeled as containing sunflower lecithin, posing a risk to allergic consumers.
Product
Item 34033-12, Chuckanut Bay Chocolate Covered Coconut Cheesecake Bites. Perishable - Keep Refrigerated. There are 8 pieces per pack and 12 packs per case. Net Wt. 6.4 oz. UPC 6 03812 34033 5. The label is read in parts: "***INGREDIENTS: CREAM CHEESE***, CHOCOLATE COMPOUND…
Category
Food
Distribution
13 states
HighFDA (Drugs)·D-1256-2022·2022-07-27
HYDROmorphone HCl Injection Syringes Recalled for Sterility Assurance
Nephron Sterile Compounding Center is recalling HYDROmorphone HCl Injection syringes nationwide due to lack of assurance of sterility. The recall affects 12,900 syringes across two manufacturing lots.
Product
HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 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: 69374-529-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1429-2022·2022-07-27
Revie Superfoods Smoothie Recalled for Potential Norovirus Contamination
Revie Superfoods Berry Blu smoothie mix is recalled due to potential norovirus contamination from frozen raspberries. The recall affects 57,960 units distributed to retailers in Pennsylvania, California, Illinois, and Texas.
Product
Revie Superfoods Berry Blu 194g Ready-to-Blend Blueberry Creamsicle Smoothie Made in Canada UPC 8 54681 00005 3 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
Category
Food
Distribution
4 states
HighFDA (Food)·F-1456-2022·2022-07-27
Chocolate Truffles Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Dark on Dark Classic Truffle products due to the potential presence of undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, and walnuts) that pose an allergen risk to sensitive consumers.
Product
Dark on Dark Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 11030 6. Ingredients: Dark chocolate, honey, butter (pasteurized cream & salt), cream, non-fat dry milk, whey, agar, algin & lecithin.
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1249-2022·2022-07-27
Compounded Injectable Medications Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 2,315 pre-filled syringes due to lack of sterility assurance. The compounded injectable medication was distributed nationwide.
Product
Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 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.…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1468-2022·2022-07-27
QBee Sea Salt Caramel Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling QBee Sea Salt Caramel due to undeclared tree nuts. The affected product was sold at ten retail locations in Colorado, New Mexico, and Wyoming, and via internet sales.
Product
QBee Sea Salt Caramel. Net wt. 1 oz. PLU Code: 788394 11010 8.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1434-2022·2022-07-27
BD Connecta Stopcock recalled for potential housing leakage risk
Becton Dickinson is recalling BD Connecta Stopcocks due to potential leakage at the housing component. The defect may interrupt treatment and expose patients to biohazardous material.
Product
BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1279-2022·2022-07-27
Sodium Bicarbonate Injection USP recalled for lack of sterility assurance
Nephron Sterile Compounding Center recalls 36,354 pre-filled syringes of Sodium Bicarbonate Injection due to lack of sterility assurance. The medication was distributed nationwide.
Product
8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1411-2022·2022-07-27
Medical Device Recall: Hill-Rom PRO+ Mattress Microclimate Feature Failure
Hill-Rom PRO+ mattresses are being recalled for a Microclimate Management feature failure that could increase pressure ulcer risk in patients. The recall affects 200 units distributed in the US and Canada.
Product
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1444-2022·2022-07-27
Aesculap S4 Cervical Cross Connector Spinal Implant System Recalled for Clamping Failure
Aesculap Implant Systems is recalling the AESCULAP S4 Cervical Cross Connector (product code SWT113T) used in spinal fusion surgery. The connectors may not clamp properly onto rods, potentially causing movement and wear particles.
Product
AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1429-2022·2022-07-27
Spinal fixation removal key fracture risk under misuse conditions
The ENNOVATE MIS removal key used in spinal fixation systems may fracture if the 90-degree angle is not maintained during use. A product redesign is underway.
Product
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1402-2022·2022-07-27
Stryker Triton Canister Scanning Labels Recalled Due to Color Variance
Stryker is recalling Triton Canister Scanning Labels that may have color variance issues, potentially resulting in lower-than-expected blood loss estimates. The recall affects 16,700 units distributed nationwide.
Product
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1281-2022·2022-07-27
Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 18,840 syringes of Succinylcholine Chloride Injection nationwide because the manufacturing process cannot be assured to have maintained sterility.
Product
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 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: 69374-919-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1449-2022·2022-07-27
Chuckanut Bay Cheesecake Bites Recalled for Undeclared Soy Allergen
Chuckanut Bay Foods LLC is recalling Sharis Strawberry Cheesecake Bites (Lot Code 2C159A2) due to undeclared soy lecithin. The label lists sunflower lecithin when the product actually contains soy lecithin, posing a risk to consumers with soy allergies.
Product
Item 81109-12, Chuckanut Bay Sharis Strawberry Cheesecake Bites. Perishable - Keep Refrigerated. There are 9 pieces per pack and 12 packs per case. The label is read in parts: "***INGREDIENTS: CREAM CHEESE***, CANE SUGAR, PASTEURIZED CULTURED MILK INGREDIENTS: CANE SUGAR…
Category
Food
Distribution
13 states
HighFDA (Devices)·Z-1436-2022·2022-07-27
BD Connecta 3-Way Stopcocks Recalled Due to Potential Leakage
Becton Dickinson recalls BD Connecta 3-Way Stopcocks due to potential leakage at the housing that may delay treatment and expose patients to biohazardous material.
Product
BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1506-2022·2022-07-27
Chicken Breading Recalled Due to Undeclared Wheat Allergen
Belmatt Inc is recalling Targil's St. Amand's Chicken Breading due to undeclared wheat. The product was distributed in Louisiana and poses a health risk to those with wheat allergies or celiac disease.
Product
Targil's St. Amand's Chicken Breading packaged in 25lb boxes
Category
Food
Distribution
1 state
HighFDA (Food)·F-1532-2022·2022-07-27
Lemon Muffins Recalled Due to Plastic Material Contamination
Portland Specialty Baking is recalling Lemon Muffins due to plastic material contamination. The affected product was distributed in California, Idaho, and Oregon.
Product
Lemon Muffins, item # 802387, are packaged in paper tray and covered with plastic film shrink wrap. Each tray contains 6 pieces and there are 6 trays per master case. PSB (Portland Specialty Baking) master case label is read in parts: "***PSB***LEMON MUFFINS *** 802387***6/36…
Category
Food
Distribution
3 states
HighFDA (Drugs)·D-1267-2022·2022-07-27
Morphine Sulfate Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Morphine Sulfate Injection syringes distributed nationwide due to lack of assurance of sterility. Approximately 43,385 syringes are affected.
Product
Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 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: 69374-979-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1454-2022·2022-07-27
Carmel Classic Truffle Recalled for Undeclared Tree Nuts
Queen Bee Gardens recalled Carmel Classic Truffle candies because they may contain undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, and walnuts). Consumers with tree nut allergies should not consume this product.
Product
Carmel Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 110005 4. Ingredients: Milk chocolate, honey, ivory chocolate, butter (pasteurized cream & salt), cream, non-fat dry milk, caramel flavor, whey, agar, algin & lecithin.
Category
Food
Distribution
Distributed nationwide