The Recall Desk

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.

16251–16275 of 53092

  • HighFDA (Devices)·Z-1546-2022·2022-08-24

    LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT Recalled Due to Improper Temperature Storage

    Family Dollar is recalling LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT that were stored without proper temperature control. Customers should discontinue use of product purchased between May 1 and June 10, 2022.

    Product
    LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT, SKU 900265
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1545-2022·2022-08-24

    Simply Saline Nasal Mist Recalled for Improper Storage Conditions

    Simply Saline Nasal Mist 3.1 oz sold at Family Dollar stores has been recalled due to improper temperature storage between May and June 2022. Consumers should return the product to their local Family Dollar store.

    Product
    SIMPLY SALINE NASAL MIST 3.1 OZ, SKU 999801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1545-2022·2022-08-24

    Factor Vegan Mushroom Marsala recalled for glass contamination in rice ingredient

    FACTOR is recalling Factor Vegan Mushroom Marsala 12.7oz meals due to glass contamination in the arborio rice ingredient. The recall affects 48,962 units with best-by dates in June and July 2022.

    Product
    Factor Vegan Mushroom Marsala with onion risotto & roasted garlic green beans 12.7oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1517-2022·2022-08-24

    Sterile Surgical Pads and Wound Care Kits Recalled Due to Structural Failure

    ASO LLC is recalling 274,458 retail packages of three wound care products that fall apart during handling after removal from packaging, compromising their sterility and usability.

    Product
    (1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1559-2022·2022-08-24

    Blue Diamond Growers recalls whole brown almonds for Salmonella risk

    Blue Diamond Growers is recalling whole brown almonds due to potential Salmonella contamination. Although none of the recalled products tested positive, the company is conducting a precautionary recall.

    Product
    Whole Brown Almonds (bulk)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1526-2022·2022-08-24

    Pregnancy Test Units Recalled Due to Improper Temperature Storage

    Clearblue Smart Countdown pregnancy tests distributed to Family Dollar stores were not stored in temperature-controlled conditions. Consumers who purchased this product should return it for a refund or replacement.

    Product
    CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1344-2022·2022-08-24

    FDA Recalls Neostigmine Methylsulfate Injectable Due to Contamination Risk

    Nephron Sterile Compounding Center is recalling one lot of Neostigmine Methylsulfate Injection due to potential cross-contamination from product carryover during manufacturing. The recall affects 13,500 vials distributed nationwide.

    Product
    PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1356-2022·2022-08-24

    Avant Foaming Hand Sanitizer recalled due to manufacturing process deviation

    Aire-Master of America is recalling Avant Foaming Hand Sanitizer due to a manufacturing process deviation where the deionized water system lacked proper microbial controls during production.

    Product
    Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Food)·F-1544-2022·2022-08-24

    HEB Ice Cream Recalled for Undeclared Wheat Allergen

    HEB Creamy Creations Light Mint Chocolate Chip ice cream (880 cups) is recalled due to undeclared wheat. Consumers with wheat allergies are at risk.

    Product
    HEB Creamy Creations Light 1/1 The Fat 1/3 Fewer Calories Of Regular Ice Cream Mint Chocolate Chip Ice Cream Half Gallon (1.89L) UPC 4122048399 packaged in a paper carton with a paper lid with a plastic edge
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1551-2022·2022-08-24

    Dressing Change Kit Recalled for Latex Mislabeling Risk

    Trinity Sterile is recalling Wolf Pak Premium Dressing Change Kits labeled as latex-free. The Non-Adherent Dressing component contains natural rubber latex, creating risk for patients with latex allergies.

    Product
    Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1549-2022·2022-08-24

    Medical Dressing Kit Recalled for Mislabeled Latex Content

    Wolf-Pak Premium Dressing Kits labeled latex-free are being recalled because a component contains natural rubber latex, posing a risk to people with latex allergies.

    Product
    Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1555-2022·2022-08-24

    BD PhaSeal Y-Site Connector recalled for mislabeled expiration dates

    Becton Dickinson recalls 9,340 units of BD PhaSeal Y-Site Connectors (Catalog 515304) due to incorrect expiration dates printed on product labels that extend beyond the actual product expiration.

    Product
    BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system. Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1552-2022·2022-08-24

    Kabobs Arancini Recalled for Possible Glass Contamination

    Kabobs Acquisition Inc. is recalling Tomato, Basil & Mascarpone Arancini products due to possible glass contamination from their rice supplier. Affected lot numbers include PM22F23, PM22F30, and PM22G13.

    Product
    Kabobs The Hors d'oeuvre Specialist TOMATO, BASIL & MASCARPONE ARANCINI 180 COUNT Prepared by: Kabobs, Inc., 5423 North Lake Dr., Lake City, GA 30260
    Category
    Food
    Distribution
    10 states
  • HighFDA (Drugs)·D-1348-2022·2022-08-24

    Acetaminophen Injection Recalled for Temperature Storage Abuse Nationwide

    Baxter Healthcare recalls 85,680 bags of acetaminophen injection nationwide due to temperature abuse in distribution. Product was shipped in refrigerated trucks despite being labeled for room temperature storage.

    Product
    ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2022·2022-08-24

    Dressing Change Kit Mislabeled as Latex-Free Contains Natural Rubber Latex

    Trinity Sterile's Wolf Pak Premium Dressing Change Kit is mislabeled as latex-free but contains natural rubber latex in component 94-7002. This poses a risk to people with latex allergies.

    Product
    Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1360-2022·2022-08-24

    Hand Sanitizer Recalled for Inadequate Microbial Control in Manufacturing

    Aire-Master of America Inc is recalling Common Sense Fragrance Free Hand Sanitizer due to a manufacturing process deviation. The product was made using deionized water from a system that lacked appropriate microbial control.

    Product
    Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-1530-2022·2022-08-24

    SKYN Non-Latex Condoms Recalled Due to Improper Storage

    Family Dollar is recalling SKYN Original, Elite, and LS non-latex condoms due to improper storage. Products sold between May 1 and June 10, 2022 were not stored in temperature-controlled conditions.

    Product
    SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-08242022-01·2022-08-24

    USDA Alerts on Poultry and Meat Products with Undeclared Milk Allergen

    USDA FSIS issued a public health alert for poultry and meat products containing corn starch with undeclared milk. Consumers should not eat these products.

    Product
    FSIS Issues Public Health Alert for Poultry and Meat Products Containing FDA-Regulated Corn Starch That Has Been Recalled Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1531-2022·2022-08-24

    Contact Lens Multi-Purpose Solution Recalled for Improper Storage

    Family Dollar is recalling BIOTRU Multi-Purpose Solution (4 oz, SKU 999009) due to improper temperature-controlled storage. Approximately 1,051 units were affected across US Family Dollar stores.

    Product
    B L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ, SKU 999009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1548-2022·2022-08-24

    Factor Tomato & Roasted Vegetable Risotto Recalled for Glass in Rice

    Factor is recalling Tomato & Roasted Vegetable Risotto (12.6 oz) because the arborio rice ingredient contains glass. The recall affects 23,439 units.

    Product
    Factor Tomato & Roasted Vegetable Risotto with toasted pine nuts 12.6oz.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1547-2022·2022-08-24

    Factor risotto recall: glass fragments found in arborio rice ingredient

    Factor is recalling its Caramelized Onion & Goat Cheese Risotto due to glass fragments in an arborio rice ingredient. The contamination poses a choking and injury risk.

    Product
    Factor Caramelized Onion & Goat Cheese Risotto with Roasted Carrots 13.5oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1359-2022·2022-08-24

    Foaming Hand Sanitizer Recalled for Water System Manufacturing Deficiency

    Protect U Guard Foaming Hand Sanitizer is being recalled because it was manufactured with deionized water from a system lacking proper microbial controls. The affected product was distributed in Florida, Illinois, Iowa, and New Jersey.

    Product
    Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-1347-2022·2022-08-24

    Labetalol HCl Injection Recalled for Manufacturing Cross-Contamination Risk

    Nephron Sterile Compounding Center is recalling PF-Labetalol HCl Injection nationwide due to manufacturing deviations that create potential for cross-contamination. No illnesses have been reported.

    Product
    PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2022·2022-08-24

    FDA Recalls Stradis Medical Surgical Scissors Due to Compromised Sterile Barrier

    Stradis Medical is recalling NARMD MEDICAL DEPOT Iris Curved Scissors (Part Number ZZ-0697) because the sterile barrier may be compromised, potentially exposing patients to contamination during surgical procedures.

    Product
    NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1551-2022·2022-08-24

    Crown Prince Smoked Baby Clams Recalled for PFAS Contamination

    Crown Prince Quality Smoked Baby Clams (3 oz cans, UPC 0 73230 00853 5) are recalled due to detectable PFAS contamination. Approximately 211,716 cans distributed nationwide are affected.

    Product
    Crown Prince Quality Natural Seafood Smoked Baby Clams Hand Packed in Olive Oil From Managed Fisheries NET WT. 3 oz. (35g) UPC 0 73230 00853 5
    Category
    Food
    Distribution
    Distributed nationwide