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.

1976–2000 of 4878

SevereFDA (Food)·F-1262-2023·2023-07-26
Good & Gather Organic Frozen Cherries & Berries Recalled for Listeria Risk
SunOpta Grains and Foods is recalling Good & Gather Organic frozen cherries and berries distributed nationwide by Target due to potential Listeria monocytogenes contamination.
Product
Good & Gather Organic cherries & berries fruit blend. Blueberries, dark sweet pitted cherries, tart pitted cherries & Strawberry slices. Net Wt 32 oz (2 lb) 907g, UPC 0 85239-04782 8. Keep Frozen. Distributed by Target Corporation Minneapolis, MN 55403
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2012-2023·2023-07-26
Olympus Bronchofiberscope BF Type recalled for combustion risk during laser procedures
Olympus bronchoscopes (Models BF-PE2 and BF-TE2) are recalled due to reports of combustion inside the airway during laser-assisted medical procedures. This is an FDA Class I recall.
Product
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1257-2023·2023-07-26
Frozen Mango Chunks Recalled for Potential Listeria Contamination
SunOpta's frozen mango chunks sold nationwide under Great Value and Good & Gather brands are recalled due to potential Listeria monocytogenes contamination. No illnesses have been reported.
Product
Mango Chunks packaged under the following brand names and sizes. 1. Great Value. Net Wt 16 oz (1 lb) 454g UPC 0 78742-02550 6. Keep Frozen. Distributed by: Walmart Inc., Bentonville, AR 72716 2. Good & Gather. Net Wt 12 oz (340 g). UPC 0 85239-04786 6. Keep Frozen
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1254-2023·2023-07-26
Trader Joe's Organic Tropical Fruit Blend recalled for potential Listeria contamination
Trader Joe's Organic Tropical Fruit Blend is recalled due to potential contamination with Listeria monocytogenes from pineapple ingredients. The 16 oz. bags were distributed nationwide.
Product
Trader Joe s Organic Tropical Fruit Blend Pineapple, Banana, Strawberry, Mango, SKU #051191, packaged in pillow bags. Each case consists of 24 bags and each bag is 16 oz. UPC on retail bag: 00511919
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1271-2023·2023-07-26
Seasons Choice Mixed Fruit Recalled for Potential Listeria Contamination
Aldi's Seasons Choice Mixed Fruit is being recalled nationwide due to potential contamination with Listeria monocytogenes. Affected lot codes are FMX227603, FMX227604, and FMX227605.
Product
Seasons Choice Mixed Fruit, Strawberries, Pinneapple, Peaches & Mango, Net Wt 32 oz (2lb) 907g. Dist & Sold Exclusively By: Aldi, Batavia, IL 60510.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1288-2023·2023-07-26
Rose Street Patisserie Multi Grain Bread Recalled for Undeclared Sesame
Rose Street Bread Lab is recalling 27 loaves of Rose Street Patisserie Multi Grain Bread due to undeclared sesame. Consumers with sesame allergies risk serious allergic reactions.
Product
Rose Street Patisserie Multi Grain Bread. Net Wt. 375 grams. 882 7th Street West, St. Paul, MN 55102
Category
Food
Distribution
1 state
SevereFDA (Food)·F-1275-2023·2023-07-26
Townsend Farms Frozen Mixed Berries Recalled for Listeria Risk
Townsend Farms' Private Selection frozen blueberries, strawberries, and mangoes are recalled due to potential Listeria monocytogenes contamination. Approximately 34,944 bags were distributed across 16 U.S. states.
Product
Private Selection 48oz Blueberries, Strawberries & Mangoes, frozen product, 8/48 oz bags per case. UPC 0 11110 89623 0. Distributed by The Kroger Co. Cincinnati, OH
Category
Food
Distribution
0 states
SevereFDA (Food)·F-1270-2023·2023-07-26
Seasons Choice frozen fruit blend recalled for potential Listeria contamination
Aldi's Seasons Choice frozen tropical fruit blend is being recalled due to potential Listeria monocytogenes contamination. No illnesses have been reported.
Product
Seasons Choice Tropical Blend, Pineapple, Mango, Strawberries & Papaya. Net Wt 32 oz (2lb) 907g. Dist & Sold Exclusively By: Aldi, Batavia, IL 60510.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2014-2023·2023-07-26
Olympus EVIS EXERA Bronchoscope Recalled for Combustion Risk During Laser Procedures
The FDA recalls 284 Olympus EVIS EXERA bronchoscopes due to complaints of combustion during therapeutic laser procedures. Users should stop using affected models immediately.
Product
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1265-2023·2023-07-26
Frozen Triple Berry Blend Recalled for Potential Listeria Contamination
Good & Gather Triple Berry Blend, sold at Target, is being recalled nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume the affected product.
Product
Good & Gather Triple Berry Blend. Blueberries, Blackberries, & Red Raspberries. Net Wt 48 oz (3lb) 1.36kg, UPC 0 85239-04806 1. Keep Frozen. Dist By Target Corp. Minneapolis, MN 55403
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1263-2023·2023-07-26
Great Value Mixed Fruit Recalled for Potential Listeria Contamination
Walmart's Great Value Mixed Fruit is recalled for potential Listeria monocytogenes contamination. The FDA issued a Class I recall affecting approximately 70,360 cases distributed nationwide.
Product
Great Value Mixed Fruit. Pineppple, Strawberries, Peaches and Mango. Net Wt 16 oz (1 lb) 454g, UPC 0 78742-02551 3. Keep Frozen. Distributed by: Walmart Inc., Bentonville, AR 72716
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2113-2023·2023-07-26
Impella LD cardiac pump recalled for impeller damage and embolization risk
Abiomed recalls Impella LD blood pumps due to potential interaction with aortic valve replacement devices that can damage the pump impeller and cause blood clots. Patients with these devices should contact their healthcare provider.
Product
Impella LD intravascular micro axial blood pump, Product Number 005082
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1293-2023·2023-07-26
Organic Asian Chopped Salad Kits Recalled for Undeclared Milk and Egg
Braga Fresh Foods is recalling 673 cases of 365 by Whole Foods Market Organic Asian Inspired Chopped Salad Kits due to undeclared milk and egg allergens. Consumers with allergies to these allergens should not consume these products.
Product
365 by Whole Foods Market Organic Asian Inspired Chopped Salad Kits 12 oz plastic bags 9 bags per case UPC: 9948246932 Item#: 9770522
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2013-2023·2023-07-26
Olympus Bronchoscope Recall: Risk of Combustion During Laser Procedures
Olympus is recalling 9 bronchoscopes (Models BF-P150 and BF-1T150) due to complaints of endobronchial combustion during therapeutic laser procedures. The defect could cause fire and serious burn injuries.
Product
Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2015-2023·2023-07-26
Olympus BRONCHOVIDEOSCOPE Model BF-Q170 Recalled Due to Combustion Risk
Olympus BRONCHOVIDEOSCOPE Model BF-Q170 is recalled nationally due to complaints of endobronchial combustion during therapeutic laser procedures, classified as FDA Class I.
Product
Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1259-2023·2023-07-26
Good & Gather Frozen Blueberries Recalled for Potential Listeria Contamination
Target's Good & Gather frozen blueberries are being recalled nationwide due to potential Listeria monocytogenes contamination affecting approximately 3,894 cases.
Product
Good & Gather Blueberries. Net Wt 48 oz (3lb) 1.36kg UPC 0 85239-04813 9. Keep Frozen. Distributed by Target Corporation Minneapolis, MN 55403
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2018-2023·2023-07-19
Oxylog 3000 Plus ventilator may stop working during operation
The Draeger Oxylog 3000 Plus emergency and transport ventilator may stop working when transitioning from battery to AC operation. Approximately 300 units distributed nationwide and internationally are affected.
Product
Oxylog 3000 Plus emergency and transport ventilator
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1241-2023·2023-07-19
Pretzel products recalled for undeclared milk allergen nationwide
Dakota Style, Inc. is recalling salt and vinegar pretzel products nationwide because they may contain undeclared milk. Consumers with milk allergies should not consume these products.
Product
1. Hy-Vee Salt & Vinegar Braided Pretzels, 10 oz poly bags, UPC: UPC: 75450-27706, 12 pack; 2. Dakota Style Salt & Vinegar Pretzel Kravings, 4.5 oz poly bags, UPC: 84872-60030, 6 pack; 3. Dakota Style Salt & Vinegar Pretzel Kravings, 10 oz poly bags, UPC 84872-60018, 12 pack, 4
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2110-2023·2023-07-19
Abbott Cardiac Catheter Sheath Recalled Due to Air Embolism Risk
Abbott is recalling the Amplatzer Steerable Delivery Sheath (ASDS), a cardiac catheter, due to a 0.77% reported incidence rate of air embolism during procedures. The recalled 675 units are distributed worldwide.
Product
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2103-2023·2023-07-19
Baxter SIGMA Spectrum Infusion Pump false upstream occlusion alarm correction
Baxter is correcting false upstream occlusion alarms in SIGMA Spectrum and Spectrum IQ infusion pumps following software upgrades affecting approximately 3,306 units distributed nationwide in the US.
Product
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0919-2023·2023-07-19
EzriCare Artificial Tears Eye Drops Recalled for Bacterial Contamination
EzriCare Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. The FDA identified non-sterile products that could pose a risk to eye health.
Product
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1231-2023·2023-07-19
Frozen strawberries recalled for potential Hepatitis A contamination
Wawona Frozen Foods recalls Organic Daybreak Blend frozen strawberries sold at Costco due to potential Hepatitis A. Approximately 9,878 cases were distributed to Costco locations in five western states with lot codes dated through October 2023.
Product
Organic Daybreak Blend Brand Name: Wawona Frozen Foods 4 lb. plastic bags - 10 bags per case Keep Frozen Item# 684779 UPC: 0 34742 07244 5 Sold by Costco
Category
Food
Distribution
5 states
SevereFDA (Food)·F-1232-2023·2023-07-19
Great Value Sliced Strawberries recalled for potential Hepatitis A contamination
Walmart's Great Value Sliced Strawberries are being recalled due to potential Hepatitis A contamination. Approximately 28,650 bags distributed across 32 states are affected.
Product
Great Value Sliced Strawberries. Item # 107356. Frozen, packaged flexible plastic bags. Net wt. 4 lbs (64oz). UPC on retail bag: 0 78742 25387 9. A total of 6 sellable units (4lbs. each) are placed into a case for distribution to retailer. DISTRIBUTED BY: Walmart Inc. Bentonvi
Category
Food
Distribution
32 states
SevereFDA (Food)·F-1234-2023·2023-07-19
Frozen fruit blend recalled for potential Hepatitis A contamination
Great Value Antioxidant Fruit Blend frozen berries are being recalled due to potential Hepatitis A contamination. The affected product was distributed across multiple states through Walmart, HEB, and Costco.
Product
Great Value Antioxidant Fruit Blend Strawberries, Blueberries, Raspberries, Pitted Dark Sweet Cherries and Pomegranate Arils. Item # 111097. Frozen, packed into flexible plastic bags. Net wt. 2lbs. 8oz. (40oz). UPC on retail bag: 0 78742 34615 1. A total of 6 sellable units (
Category
Food
Distribution
32 states
SevereFDA (Food)·F-1239-2023·2023-07-19
Frozen Deviled Crabs Recalled for Undeclared Milk and Sesame Seeds
SANTOS FROZEN FOODS is recalling Regular Deviled Crabs (4oz) for undeclared milk and sesame allergens. Approximately 520 cases were distributed domestically in affected lots beginning with 23 and ending in 03, 04, or 05.
Product
Regular Deviled Crabs, 4oz
Category
Food
Distribution
0 states