Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

3326–3350 of 4878

SevereFDA (Food)·F-1672-2022·2022-09-07
Kate Farms Pediatric Peptide Formula Recalled for Bacterial Contamination
Lyons Magnus is recalling kate farms Pediatric Peptide formula nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. The recall affects 53.8 million units of this ready-to-use pediatric nutrition formula.
Product
kate farms Pediatric Peptide 1.5 Cal/mL, Vanilla, Sole-Source Nutrition Formula. 250 mL (8.45 fl oz) UPC 8 51823-00687 4. 12 count case UPC 00851823006201. Shake Well. A ready-to-use oral and tube feeding formula with enzymatically hydrolyzed organic pea protein. Made for
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1602-2022·2022-09-07
Glucerna original Vanilla Shake recalled for bacterial contamination
Lyons Magnus is recalling Glucerna original Vanilla Shake due to findings of Cronobacter sakazakii and potential Clostridium botulinum. Over 53 million units were distributed nationwide.
Product
Glucerna original Homemade Vanilla Shake, 8 FL OZ (237 mL). Delicious Snack or Small Meal Replacement. UPC 0 70074-68563 2. Sold in 24 count case, Case UPC 0070074685625. Shake Well. Serve cold. Refrigerate after opening. Manufactured for: Abbott Nutrition, Abbott Labor
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1583-2022·2022-09-07
Lemon Dill Butter Pucks Recalled for Listeria Contamination
Raw Seafoods Inc. is recalling Lemon Dill Butter Pucks due to Listeria monocytogenes contamination from a recalled dill ingredient. The product was distributed to Ohio and Massachusetts.
Product
Lemon Dill Butter Pucks
Category
Food
Distribution
2 states
SevereFDA (Devices)·Z-1521-2022·2022-09-07
NIM EMG Endotracheal Tubes recalled for risk of airway obstruction
Medtronic Xomed is recalling NIM EMG Endotracheal Tubes due to reports of airway obstruction during use. The recall affects 23,820 units distributed worldwide.
Product
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1663-2022·2022-09-07
Abbott PediaSure Harvest 1.0 Cal tube-feeding formula recalled nationwide
Abbott PediaSure Harvest 1.0 Cal tube-feeding formula is recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Approximately 53,818,025 units with specific lot codes spanning September 2022 through April 2023 are affected.
Product
Abbott PediaSure Harvest 1.0 Cal, For Tube Feeding. Complete nutrition blend. 8 fl oz (237mL). UPC 0 70074-67963 1. 24 count case UPC 00070074679624. Shake very well. Store unopened at room temperature. Once opened, reclose, refrigerate, and use within 24 hours. Manufact
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1676-2022·2022-09-07
Oatly Oat Drink Recalled for Bacterial Contamination Findings
Oatly Oat Drink Deluxe 330ml is being recalled for findings of Cronobacter sakazakii and Clostridium botulinum. Approximately 53.8 million units nationwide are affected. Consumers should not consume the product.
Product
PROUCT WAS NOT DISTRIBUTED IN US. The Original Oatly! Oat Drink Deluxe 330ml. UPC 7 394376 619021 18 count case UPC 27394376619025. Shake well before drinking. Produced in the USA. Oatly AB, Stora Varvsgatan 6a, SE-211 19 Malmo.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1673-2022·2022-09-07
Oatly Oat-Milk Barista Edition recalled for potential bacterial contamination
Lyons Magnus is recalling Oatly Oat-Milk Barista Edition (11 fl oz) nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume the product.
Product
The Original Oatly! Oat-Milk Barista Edition. 11 fl oz (330ml). UPC 1 90646-63012 6. 18 count case UPC 20190646630120. Once opened, store in refrigerator and consume within 7 days. Distributed by: Oatly Inc., New York, NY 10017.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1617-2022·2022-09-07
Lyons Barista Oat Beverage Recalled for Potential Bacterial Contamination
Lyons Magnus is recalling Lyons Barista Style Oat, a plant-based milk beverage distributed nationwide, due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.
Product
Lyons Barista Style Oat, Non-Dairy Beverage. Plant-Based Milk. 32 FL OZ (1 QT) 946mL UPC 0 45796-10180 7. 12 count case UPC 10045796101804. Shake Well before Serving. After opening keep refrigerated and use within 7 days. Lyons Magnus, Fresno, CA 93702.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1619-2022·2022-09-07
Pirq Caramel Coffee Plant Protein Drink Recalled for Bacterial Contamination
Pirq Plant Protein Super Foods Caramel Coffee Drink has been recalled nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination affecting 53,818,025 units.
Product
pirq Plant Protein Super Foods, Caramel Coffee Drink, Almonds, Curcumin, Maca. 11 FL OZ (325ML). UPC 8 57690-00808 9. Packaged in the following configurations: 1. 12 count case UPC 857690008140. 2. 4 count wrap UPC 857690008263. Chill it, Shake it. Do not Fr
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1659-2022·2022-09-07
Rejuvenate Muscle Health+ chocolate drink recalled nationwide for bacterial pathogens
Lyons Magnus, Inc. is recalling Rejuvenate Muscle Health+ Chocolate, a nationwide distributed ready-to-drink beverage, due to findings and potential presence of Cronobacter sakazakii and Clostridium botulinum.
Product
Rejuvenate Muscle Health+ Chocolate 11 fl oz. (330mL). UPC 6 29046-50401 5. Serve Cold, shake well. Manufactured exclusively for Element Nutrition, Ltd., 1887 Whitney Mesa Dr. #6020, Henderson, NV 89014. 4-count wrap UPC 629046544011.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1669-2022·2022-09-07
Kate Farms Nutrition Shake recalled nationwide for pathogenic contamination
Kate Farms Nutrition Shake is recalled nationwide due to findings of Cronobacter sakazakii and Clostridium botulinum. The recall covers multiple lot codes with best-by dates spanning September 2022 to January 2023.
Product
kate farms Nutrition Shake, Vanilla. 11 fl oz (325 mL) UPC 8 11112-03058 4. 12 count case UPC 00811112030591. Shake Well. After opening, refrigerate and use within 4 days. Made for Kate Farms, Inc., 101 Innovation Place, Santa Barbara, CA 93708
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1664-2022·2022-09-07
Abbott PediaSure Harvest infant nutrition recalled for bacterial contamination
Abbott PediaSure Harvest 1.0 Cal formula is being recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum bacteria.
Product
Abbott PediaSure Harvest 1.0 Cal, For Tube Feeding. Complete nutrition blend. 8 fl oz (237mL). UPC 0 70074-67963 1. 24 count case UPC 00070074679624. Shake very well. Store unopened at room temperature. Once opened, reclose, refrigerate, and use within 24 hours. Manufact
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1640-2022·2022-09-07
Stumptown Cold Brew Coffee Recalled for Potential Bacterial Contamination
Stumptown Cold Brew Coffee with Oat Milk Original is being recalled due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected products were distributed nationwide.
Product
Stumptown Cold Brew Coffee with Oat Milk Original. Plant Based. Low Sugar. Made with Oatly! 11 Fl Oz. 325 ML. UPC 8 55186-00687 8. Sold in 12-count case UPC 108551860006875. Manufactured for Stumptown Coffee Roasters, 100 SE Salmon St. Portland, OR 97214
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1622-2022·2022-09-07
Nationwide recall of Oatly Oat-Milk Barista Edition for bacterial contamination
Oatly Oat-Milk Barista Edition is recalled nationwide for potential Cronobacter sakazakii and Clostridium botulinum contamination. Approximately 53.8 million units are affected, spanning multiple lot codes from August 2022 through April 2023.
Product
The Original OATLY Oat-Milk Barista Edition. 32 fl oz (1qt) (946mL). UPC 1 90646-63005 8. Packaged in 12 count case UPC 10190646630055. Once opened store in refrigerator and consume within 7 days. Enjoy chilled. Distributed by: Oatly, Inc., 220 E 42nd St. Ste 409A
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1605-2022·2022-09-07
Aloha Organic Protein Drink Recalled for Bacterial Contamination
Aloha Organic Protein Drink in Vanilla flavor is being recalled nationwide due to findings of Cronobacter sakazakii and Clostridium botulinum. Affected products include specific lot codes with best-by dates from 2022 and 2023.
Product
Aloha Organic Protein Drink, Vanilla Plant-based protein. Net 11 FL OZ (330 mL) Tetra Pak container UPC 8 42096-11234 8. Sold in 4 count Package wrap with UPC 842096122347. Shake Well. Best Chilled. Manufactured for: Aloha, Littleton, CO 80127
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1520-2022·2022-09-07
NIM EMG Endotracheal Tubes recalled for risk of airway obstruction
Medtronic Xomed recalls 1.1 million NIM EMG Endotracheal Tubes worldwide due to reports of airway obstruction. FDA classified this as Class I.
Product
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1631-2022·2022-09-07
Sysco Imperial Dairy Drink Recalled for Cronobacter and Botulism
Lyons Magnus recalled Sysco Imperial Thickened Dairy Drink nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. The FDA Class I recall affects over 53 million units distributed in 8 oz and 32 oz containers.
Product
Sysco Imperial Thickened Dairy Drink. Moderately Thick Honey Consistency. Pasteurized - Made with Grade A 2% Fat Milk, Vitamins A & D. Packaged in the following sized Tetra Pak containers: 1. 8 FL OZ (237 mL) UPC 0 74865-94550 9. Reorder # 0429357. 24 count case UPC
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1607-2022·2022-09-07
Cold Coffee Recalled Nationwide for Bacterial Contamination Risk
Intelligentsia Cold Coffee in 10.9 oz containers is recalled nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. Consumers should not consume the product.
Product
Intelligentsia, Cold Coffee. Net 10.9 fl oz (325 mL) Tetra Pak container UPC 8 00222-00096 9. Shake Best enjoyed cold. Refrigerate after opening. Produced for: Intelligentsia Coffee, Inc., Aloha, Chicago, IL 60612.
Category
Food
Distribution
Distributed nationwide
SevereNHTSA·22V313000·2022-09-05
2023 Winnebago Ekko RV Recalled for Cracked LP Gas Fittings
Winnebago is recalling 2021-2023 Ekko recreational vehicles because quick disconnect fittings in the LP gas system may crack, potentially causing a gas leak that could lead to fire.
Product
WINNEBAGO — 2023 WINNEBAGO EKKO
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V271000·2022-09-04
2021 Porsche Cayenne recalled for rear axle suspension defect
Porsche is recalling certain 2021 Cayenne models because lock nuts on the rear axle may break due to stress corrosion, potentially causing loss of control and crash risk.
Product
PORSCHE — 2021 PORSCHE CAYENNE
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·22215·2022-09-01
UPPAbaby RIDGE Jogging Strollers Recalled for Fingertip Amputation Hazard
UPPAbaby is recalling about 14,400 All-Terrain RIDGE jogging strollers because openings in the rear disc brakes can catch and amputate a child's fingertip. One injury has been reported.
Product
UPPAbaby All-Terrain RIDGE Jogging Strollers
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Food)·F-1577-2022·2022-08-31
Tovala gochujang pork bowl meals recalled for undeclared peanut allergen
Tovala is recalling approximately 3,340 Gochujang-Glazed Pork Chop Bowl meals distributed nationwide because they contain undeclared peanuts, which pose an allergy risk to consumers with peanut allergies.
Product
Tovala Gochujang-Glazed Pork Chop Bowl meal No.9-A
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1560-2022·2022-08-31
Getinge Servo ventilator systems recalled for loss of ventilation
Getinge Servo ventilators may fail to deliver ventilation and stop functioning, potentially causing oxygen deprivation and serious harm to critical care patients.
Product
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1561-2022·2022-08-31
Diaphragm pacing system external pulse generator recalled for circuit board defect
Synapse Biomedical is recalling the NeuRx Diaphragm Pacing System External Pulse Generator due to a circuit board defect causing performance degradation, potentially leading to cardiac complications, breathing failure, or device shutdown.
Product
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Category
Medical Device
Distribution
12 states
SevereFDA (Food)·F-1576-2022·2022-08-31
Tovala Salmon Meal Recalled Due to Undeclared Peanut Allergen
Tovala is recalling its Gochujang-Glazed Salmon Bowl meal (No. 18-A) because it contains an undeclared peanut allergen. The affected products were distributed nationwide to consumers.
Product
Tovala Gochujang-Glazed Salmon Bowl meal No.18-A
Category
Food
Distribution
Distributed nationwide