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.

16526–16550 of 53124

HighFDA (Food)·F-1477-2022·2022-07-27
Honey Caramels Huckleberry Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honey Caramels Huckleberry (5.87 oz) because they may contain undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. This poses a serious health risk to people with tree nut allergies.
Product
Honey Caramels Huckleberry. Net wt. 5.87 oz. PLU Code: 788394 12623 9. Ingredients: Honey, butter (pasteurized cream & salt), cream, nonfat dry milk, natural flavors, purple cabbage (coloring), whey, lecithin, algin & agar.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1450-2022·2022-07-27
LumiraDx SARS-CoV-2 Antibody Test Strip Modified Outside Approved Scope
LumiraDx recalled SARS-CoV-2 Antibody Test Strips after discovering modifications were made outside the FDA-approved Emergency Use Authorization scope. The recall affects 635 units in 13 states.
Product
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
Category
Medical Device
Distribution
13 states
HighFDA (Drugs)·D-1339-2022·2022-07-27
Dietary Supplement Marketed as Unapproved Drug Recalled by FDA
Launch Sequence Capsules, a dietary supplement sold in 60-count bottles, were recalled because they were marketed without FDA approval as a drug based on label claims.
Product
Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1492-2022·2022-07-27
Honeymoon Cinna-Bee Patties recalled due to undeclared tree nuts
Queen Bee Gardens is recalling Honeymoon Cinna-Bee Patties due to potential undeclared tree nuts: pecans, almonds, coconut, macadamia nuts, and walnuts. Products were distributed in Colorado, New Mexico, Wyoming, and nationwide online.
Product
Honeymoon Cinna-Bee Patties. PLU Code: 788394 14892 7
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1483-2022·2022-07-27
Honeymoons Milk Chocolate Almond Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honeymoons Milk Chocolate Almond candy due to undeclared tree nuts including pecans, almonds, coconut, macadamia, and walnuts. The product was distributed in Colorado, New Mexico, Wyoming, and nationwide online.
Product
Honeymoons Milk Chocolate Almond. PLU Code: 788394 14756 2.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1435-2022·2022-07-27
Revive Superfoods Strawberry Zen Smoothie Mix Recalled for Norovirus Risk
Revive Superfoods Strawberry Zen smoothie mix is being recalled due to potential norovirus contamination in IQF raspberries used as an ingredient. The recall affects 57,960 units distributed to consumers in Pennsylvania, California, Illinois, and Texas.
Product
Revie Superfoods Strawberry Zen 222g Ready-to-Blend Strawberry Banana Smoothie Made in Canada UPC 8 54681 00003 9 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
Category
Food
Distribution
4 states
HighFDA (Food)·F-1490-2022·2022-07-27
Honeymoons Ivory Chocolate Pecan Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honeymoons Ivory Chocolate Pecan due to undeclared tree nuts, which may affect consumers with tree nut allergies. The product was sold at retail locations in Colorado, New Mexico, and Wyoming, plus nationwide internet sales.
Product
Honeymoons Ivory Chocolate Pecan. PLU Code: 788394 14730 0
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1285-2022·2022-07-27
Aripiprazole 20mg Tablets Recalled for Failed Dissolution
Apotex Corp. is recalling 2,010 bottles of Aripiprazole Tablets 20mg nationwide due to failed dissolution specifications. Tablets may not dissolve properly, potentially affecting medication effectiveness.
Product
Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston…
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·22V542000·2022-07-27
2022 Volkswagen Golf R Sunroof Switch May Close Unexpectedly
Volkswagen is recalling certain 2022 Golf R and Golf GTI vehicles because the sunroof touch switch may be too sensitive and inadvertently pressed, causing unintended sunroof auto-closure and risking injury.
Product
VOLKSWAGEN — VOLKSWAGEN GTI, GOLF R
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-1499-2022·2022-07-27
Dark Raspberry Classic Snack Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Dark Raspberry Classic snacks due to undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts) that may be present, posing a risk to consumers with tree nut allergies.
Product
Dark Raspberry Classic. Net wt. 1.4 oz. UPC 788394 10003 1.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1441-2022·2022-07-27
Nexiva IV Catheter Stopcock May Leak During Infusion
Becton Dickinson is recalling specific lots of Nexiva IV catheters because the stopcock housing may leak, potentially interrupting treatment and exposing patients to infusate and biohazardous material.
Product
Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1434-2022·2022-07-27
Revie Superfoods Raspberry & Mango Smoothie Recalled for Potential Norovirus
Revive Organics is recalling Revie Superfoods Raspberry & Mango Smoothie products because they may contain norovirus from contaminated raspberries. Consumers in PA, CA, IL, and TX who have purchased this product should not consume it.
Product
Revie Superfoods Raspberry & Mango 188g Ready-to-Blend Smoothie Made in Canada UPC 8 54681 00026 8 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
Category
Food
Distribution
4 states
HighFDA (Drugs)·D-1258-2022·2022-07-27
FDA Recalls HYDROmorphone Injection Syringes Due to Sterility Concerns
Nephron Sterile Compounding Center is recalling 3,740 HYDROmorphone injection syringes due to lack of assurance of sterility. The affected lot was distributed nationwide.
Product
HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 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. Extension, West Columbia, SC 29172, NDC: 69374-559-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1437-2022·2022-07-27
Chuckanut Bay Cheesecake Bites Recalled for Undeclared Soy Allergen
Chuckanut Bay Foods LLC is recalling New York Cheesecake Bites because the label declares sunflower lecithin when the product actually contains undeclared soy lecithin, posing a risk to consumers with soy allergies.
Product
Item 32001-56, Chuckanut Bay New York Cheesecake Bites (Milk Compound) BULK. Perishable - Keep Refrigerated. There are 14 pieces per pack and 56 packs per case. Item 34001-12, Chuckanut Bay Cheesecake Bites New York. Perishable - Keep Refrigerated. Net Wt. 6.4 oz. There…
Category
Food
Distribution
13 states
HighFDA (Devices)·Z-1446-2022·2022-07-27
Cervical spinal implant connectors may have insufficient clamping force
Aesculap S4 Cervical Cross Connectors used in spinal fusion surgery may have insufficient clamping force, potentially causing movement of the connectors on the rods or wear debris.
Product
AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1387-2022·2022-07-27
SX-One MicroKnife Recalled for Potential Dull Blade Defect
Sonex Health LLC is recalling approximately 3,752 SX-One MicroKnife surgical instruments nationwide due to potential blade dulling that may compromise proper function.
Product
SX-One MicroKnife
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1253-2022·2022-07-27
Glycopyrrolate Injection Recalled for Lack of Sterility Assurance
Nephron is recalling Glycopyrrolate Injection pre-filled syringes distributed nationwide due to lack of sterility assurance. The recall affects 3,690 syringes from lot GL2001A, expiration 7/15/2022.
Product
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 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: 69374-903-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2022·2022-07-27
Medical Device Thawing Kit Recalls Due to Spanish Instruction Translation Error
CooperSurgical recalls its LifeGlobal Fast Freeze Thawing Kit due to a Spanish instruction translation error that specifies 5 minutes instead of 5 seconds for blastocyte air thawing, affecting 403 units.
Product
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Category
Medical Device
Distribution
31 states
HighFDA (Drugs)·D-1261-2022·2022-07-27
Ketamine HCl Injection Recalled for Lack of Sterility Assurance
Nephron is recalling 47,905 pre-filled syringes of Ketamine HCl Injection nationwide due to lack of sterility assurance. Users should contact the manufacturer for handling instructions.
Product
Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 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: 69374-511-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1467-2022·2022-07-27
QBee Honeycomb Toffee Dark Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling QBee Honeycomb Toffee Dark due to undeclared tree nuts. The product may contain pecans, almonds, coconut, macadamia nuts, or walnuts.
Product
QBee Honeycomb Toffee Dark. Net wt. 1.5 oz. PLU Code: 788394 10504 3.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1432-2022·2022-07-27
Coconut cream smoothie recalled for potential norovirus contamination
Revive Organics is recalling Revie Superfoods Coconut Cream 190g due to potential norovirus contamination from individually quick-frozen raspberries. Affected units were distributed to consumers in Pennsylvania, California, Illinois, and Texas.
Product
Revie Superfoods Coconut Cream 190g Ready-to-Blend Coconut Delight Smoothie Made in Canada UPC 8 54681 00016 9 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-1440-2022·2022-07-27
Nexiva Infusion Device Stopcock May Leak During Treatment
Becton Dickinson is recalling Nexiva infusion devices with pink stopcock components due to potential leakage at the housing that could interrupt treatment or expose patients to infusate and biohazardous material.
Product
Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1396-2022·2022-07-27
Surgical Seal Packaging May Compromise Sterility in Laparoscopic Devices
Surgical Innovations Ltd recalls YelloPort Elite Universal Seals due to potential holes in packaging that may affect product sterility. Worldwide distribution affected.
Product
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1458-2022·2022-07-27
Fudge Classic Truffle recalled for undeclared tree nuts
Queen Bee Gardens is recalling Fudge Classic Truffle candy because it may contain undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. Consumers with tree nut allergies should not consume this product.
Product
Fudge Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 11045 0. Ingredients: Dark chocolate, milk chocolate, honey, butter (pasteurized cream & salt), cream, non-fat dry milk, whey, agar, algin, lecithin & natural flavors.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1431-2022·2022-07-27
BD Connecta Infusion Stopcock Recall Due to Potential Housing Leakage
BD Connecta Stopcock infusion devices may leak at the housing component, potentially delaying or interrupting treatment and exposing patients to biohazardous material. The recall affects 485,000 units distributed worldwide.
Product
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
Category
Medical Device
Distribution
Distributed nationwide