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.

15851–15875 of 53092

HighFDA (Devices)·Z-1764-2022·2022-09-28
FDA expands recall: HLS Set Advanced 7.0 sterility barrier compromise
Maquet Medical Systems USA has expanded a recall for HLS Set Advanced 7.0, a preconnected medical device used for heart and lung support, due to a potential breach in the sterility barrier that could compromise product sterility.
Product
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1772-2022·2022-09-28
Serological Test Positive Control Shows False Negative Results for Hepatitis B
Randox Serology I Positive Control may test negative for Hepatitis B surface antigen (HBsAg) on certain analyzers despite being designed as a positive control, potentially affecting laboratory quality control procedures.
Product
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1743-2022·2022-09-28
Dark Chocolate Date Truffles Recalled for Undeclared Milk Allergen
That's It. Dark Chocolate Date Truffles are recalled for containing undeclared milk (casein and whey). Consumers with milk allergies should not consume these products.
Product
That's It. Dark Chocolate Date Truffles Net WT. 3.5 oz, 5.0 oz, and 16.0 oz Ingredients: Organic Dates, Organic Dark Chocolate (Organic Unsweetened Chocolate, Organic Sugar, Organic Cocoa Butter). Prepared by: That's It Nutrition LLC Los Angeles, CA 90014 CA.THATSITFRUIT>COM…
Category
Food
Distribution
8 states
HighFDA (Food)·F-1764-2022·2022-09-28
Kiwi and strawberry products recalled due to inadequate sanitizer
Russ Davis Wholesale is recalling kiwi and strawberry products distributed across six Midwest states due to inadequate sanitizer in wash water, creating risk of pathogenic contamination. No illnesses have been reported.
Product
Kiwi, Strawberry. Keep Refrigerated. Packaged in the following brands and sizes: 1. Item 80850. Net Wt. 12 oz. Crazy Fresh, quick & easy, and grocery store branded. 2. Item 80871. Net Wt 20 oz. Crazy Fresh, quick & easy, and grocery store branded.
Category
Food
Distribution
6 states
HighFDA (Food)·F-1776-2022·2022-09-28
Blueberry Salsa Recalled Due to Inadequate Wash Water Sanitation
Russ Davis Wholesale is recalling Blueberry Salsa due to inadequate sanitizer in wash water. The product was distributed to retailers in Iowa, Michigan, Minnesota, North Dakota, South Dakota, and Wisconsin.
Product
Blueberry Salsa. Contains: Mango, Blueberries, Red Bell Pepper, Pineapple, Green Bell Pepper, Papaya, Jalapeno Pepper, Onion, Orange, Cilantro, Lime Juice. Keep Refrigerated. Packaged in the following brands and sizes: 1. Item 85094. Net Wt. 8 oz. Crazy Fresh…
Category
Food
Distribution
6 states
HighFDA (Food)·F-1773-2022·2022-09-28
Veggie Blend with Dip recalled due to inadequate wash water sanitizer
Russ Davis Wholesale is recalling Veggie Blend with Dip products due to inadequate sanitizer in wash water. The recall affects products in six Midwestern states.
Product
Veggie Blend with Dip. Contains: Carrots, Cauliflower, Broccoli, Dill Dip. Keep Refrigerated. Net Wt. 12 oz. Item 82714. Packaged in the following brands Crazy Fresh, quick & easy, and grocery store brands.
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-1769-2022·2022-09-28
Hemodialysis Water Purification Unit Recalled for Missing EMI Shielding
Fresenius is recalling 24 units of the AquaC UNO H reverse osmosis unit because internal ethernet cables lack ferrite cores, compromising electromagnetic compatibility in hemodialysis water purification systems.
Product
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1740-2022·2022-09-28
That's It. Dark Chocolate Banana Truffles Recalled for Undeclared Milk
That's It. Dark Chocolate Banana Truffles are being recalled because they contain undeclared milk (casein and whey). People with milk allergies should not consume these products.
Product
That's It. Dark Chocolate Banana Truffles Net WT. 3.5 oz, 5.0 oz, and 16.0 oz Ingredients: Organic Bananas, Organic Dark Chocolate (Organic Unsweetened Chocolate, Organic Sugar, Organic Cocoa Butter) Prepared by: That's It Nutrition LLC Los Angeles, CA 90014 CA.THATSITFRUIT>COM…
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-1765-2022·2022-09-28
Medical device set recalled for potential sterility barrier compromise
Maquet Medical Systems USA is recalling the BEQ-HLS 5050 (HLS Set Advanced 5.0) due to a potential breach in the sterility barrier that may compromise product sterility.
Product
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1754-2022·2022-09-28
BD MaxGuard Extension Set Mislabeled with Wrong Expiration Year
BD MaxGuard Flow Controller Extension Set labels incorrectly list 2027 expiration instead of 2025. Use of expired product could compromise device integrity and create infection risk.
Product
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
Category
Medical Device
Distribution
39 states
HighFDA (Food)·F-1783-2022·2022-09-28
Vegetable Medley from Russ Davis Wholesale Recalled for Inadequate Sanitizer
Russ Davis Wholesale is recalling 87,915 units of Vegetable Medley products due to inadequate sanitizer in wash water. The recall affects products distributed across six Midwestern states.
Product
Vegetable Medley. Contains: Carrot, Broccoli, Cauliflower. Keep Refrigerated. Item 89334. Net Wt. 12 oz. Kowalski's Markets.
Category
Food
Distribution
6 states
HighFDA (Food)·F-1746-2022·2022-09-28
Golden Pacific California Sliced Almonds Recalled for Peanut Allergen Contamination
J & N Nut Products Inc. recalls Golden Pacific California Sliced Almonds due to FDA-detected peanut protein contamination. The 25-pound bulk product was distributed in California only.
Product
Golden Pacific California Shelled Almonds Sliced Almonds 25 LBS. NET WEIGHT Store away from heat Cold storage recommended 32-40F
Category
Food
Distribution
1 state
HighFDA (Food)·F-1747-2022·2022-09-28
Sliced Peanuts Recalled Due to Almond Allergen Cross-Contamination
J & N Nut Products recalls sliced peanuts because FDA sampling detected almond protein in the product. The 30,000-pound recall affects California distribution.
Product
Sliced Peanuts 25 LBS. NET WEIGHT Store away from heat Cold storage recommended 32-40F
Category
Food
Distribution
1 state
HighFDA (Food)·F-1779-2022·2022-09-28
Fresh fruit products recalled due to inadequate sanitation in wash water
Russ Davis Wholesale is recalling Mango Tango fruit products (87,915 units) distributed in six Midwest states. The recall is due to inadequate sanitizer in wash water.
Product
Mango Tango. Contains: Mango, Pineapple, Strawberry, Oranges, Blueberries. Keep Refrigerated. Item 89273. Net Wt. 16 oz. Kowalski's Markets.
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-1759-2022·2022-09-28
BD MaxGuard Extension Set Recalled for Incorrect Expiration Year
CAREFUSION's BD MaxGuard Extension Set is being recalled because product labels incorrectly list expiration year 2027 instead of 2025. Using expired product may compromise integrity, potentially causing leaks and infection risk.
Product
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
Category
Medical Device
Distribution
39 states
HighFDA (Food)·F-1742-2022·2022-09-28
Dark Chocolate Fig Truffles Recalled Due to Undeclared Milk
That's It. Dark Chocolate Fig Truffles are recalled because they contain undeclared milk. Testing revealed casein and whey in the product, posing a risk to consumers with milk allergies.
Product
That's It. Dark Chocolate Fig Truffles Net WT. 3.5 oz, 5.0 oz, and 16.0 oz Ingredients: Organic Figs, Organic Dark Chocolate (Organic Unsweetened Chocolate, Organic Sugar, Organic Cocoa Butter) Prepared by: That's It Nutrition LLC Los Angeles, CA 90074 CA.THATSITFRUIT.COM…
Category
Food
Distribution
8 states
HighNHTSA·22V721000·2022-09-28
Rolls-Royce Phantom Headlight Coating Defect Recall
BMW is recalling 2023 Rolls-Royce Phantom vehicles because headlights may lack metal coating, causing low beams to fail FMVSS 108 and increasing crash risk.
Product
ROLLS-ROYCE — ROLLS-ROYCE PHANTOM
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-1755-2022·2022-09-28
Strawberry and Pineapple Products Recalled Due to Inadequate Sanitation
Russ Davis Wholesale is recalling strawberry and pineapple products across six Midwest states due to inadequate sanitizer in wash water. The recall affects approximately 87,915 units.
Product
Strawberry & Pineapple. Packaged in the following brands and sizes: 1. Item 80640. Net Wt. 14 oz. Crazy Fresh 2. Item 80868. Net Wt 20 oz. Crazy Fresh, quick & easy, and grocery store branded. 3. Item 89274. Hawaiian Crush Net Wt. 16 oz. Kowalski's Markets
Category
Food
Distribution
6 states
HighFDA (Food)·F-1786-2022·2022-09-28
Roasting Vegetables Recalled Due to Inadequate Wash Water Sanitization
Russ Davis Wholesale is recalling roasting vegetables sold at Kowalski's Markets due to inadequate sanitizer in wash water. The recall affects 87,915 units in six Midwestern states.
Product
Roasting Vegetables. With Olive Oil and Herbs. Contains: . Keep Refrigerated. Item 89350. Butternut Squash, Brussel Sprouts, Cauliflower, Carrot, Parsnip, Olive Oil, Salt, Black Pepper, Sage, Rosemary, Thyme. Net Wt. 28 oz. (1 lb 12 oz) 793 g. Kowalski's Markets.
Category
Food
Distribution
6 states
HighFDA (Food)·F-1778-2022·2022-09-28
Refrigerated fruit blend recalled for inadequate wash water sanitization
Russ Davis Wholesale is recalling Caribbean Dream refrigerated fruit products sold under Kowalski's Markets due to inadequate sanitizer in wash water. The recall affects 87,915 units distributed across six Midwest states.
Product
Caribbean Dream. Contains: Pineapple, Mango, Strawberry, Papaya. Keep Refrigerated. Packaged in the following brands and sizes: 1. Item 89271. Net Wt. 16 oz. Kowalski's Markets. 2. Item 89276. Net Wt. 40 oz. Kowalski's Markets.
Category
Food
Distribution
6 states
HighFDA (Food)·F-1782-2022·2022-09-28
Cauliflower Rice Recalled Due to Inadequate Sanitizer in Wash Water
Russ Davis Wholesale is recalling 87,915 units of Cauliflower Rice with Lemon and Garlic Olive Oil due to inadequate sanitizer in wash water during processing. Affected products were distributed across IA, MI, MN, ND, SD, and WI.
Product
Cauliflower Rice. With Lemon and Garlic Olive Oil Contains: Cauliflower, lemon Garlic, Olive Oil (Olive Oil, Lemon Juice, Garlic). Keep Refrigerated. Item 89307. Net Wt. 12 oz. Kowalski's Markets.
Category
Food
Distribution
6 states
HighFDA (Food)·F-1770-2022·2022-09-28
Sunset Fruit Bowl Recalled Due to Inadequate Sanitizer in Wash Water
Russ Davis Wholesale is recalling Sunset Fruit Bowl because of inadequate sanitizer in the wash water used during processing. The recall affects 87,915 units sold in Iowa, Michigan, Minnesota, North Dakota, South Dakota, and Wisconsin.
Product
Sunset Fruit Bowl. Contains: Pineapple, Honeydew, Cantaloupe, Grapes, Blueberries, Strawberries. Keep Refrigerated. Item 81109. Net Wt. 3.5 lbs. Packed under grocery store brands.
Category
Food
Distribution
6 states
HighFDA (Food)·F-1781-2022·2022-09-28
Summer Party Fruit Bowl Recalled Due to Inadequate Sanitation
Russ Davis Wholesale is recalling Summer Party Fruit Bowl products distributed across six Midwestern states due to inadequate sanitizer in wash water, which could allow bacterial contamination.
Product
Summer Party Fruit Bowl. Contains: Cantaloupe, Watermelon, Grapes, Strawberries, Blueberries. Water Keep Refrigerated. Item 89296. Net Wt. 64 oz. Kowalski's Markets.
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-1752-2022·2022-09-28
BD MaxGuard Extension Set labeled with incorrect expiration year 2027
46,900 BD MaxGuard Extension Sets are labeled with expiration year 2027 but should expire in 2025. Using expired product may compromise integrity and cause leaks, risking infection.
Product
BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
Category
Medical Device
Distribution
39 states
HighFDA (Food)·F-1774-2022·2022-09-28
Vegetable Tray with Dip Recalled for Inadequate Sanitization
Russ Davis Wholesale is recalling vegetable trays with dip distributed in the upper Midwest because the wash water lacked adequate sanitizer, which could allow bacteria to remain on the produce.
Product
Veg Tray with Dip. Contains: Carrots, Celery, Broccoli, Dill Dip. Keep Refrigerated. Net Wt. 1.5 lbs. Item 81861. Packaged in the following brands Crazy Fresh, quick & easy, and grocery store brands.
Category
Food
Distribution
6 states