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.

14176–14200 of 53090

  • HighFDA (Devices)·Z-1154-2023·2023-03-01

    Folate test kits recalled for calibration error causing inaccurate results

    Siemens is recalling ADVIA Centaur Folate 500 test kits because a calibration error causes inaccurate, falsely low results when testing serum samples, potentially affecting diagnostic accuracy.

    Product
    ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10331250 Siemens Material Number (SMN): 10325366
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0360-2023·2023-03-01

    Pilgrim's Roasted Nut'Z Creme Brulee Cashews Recalled for Undeclared Walnut

    Pilgrim's Roasted Nut'Z Creme Brulee Cashews are recalled for undeclared walnut. The product was distributed in California, Oregon, and Washington and poses a risk to consumers with walnut allergies.

    Product
    Pilgrim's Roasted Nut'Z Creme Brulee Cashews are packaged by hand into either the 8 oz Plastic Cone Bags or 8 Oz Pouch Bags. Label declares Cashews, Sugar, French Vanilla Syrup, Caramel Syrup.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1162-2023·2023-03-01

    Medline Sterile Maximum Barrier Pack-LF units recalled for sterilization failure

    Medline Industries recalls approximately 720 Sterile Maximum Barrier Pack-LF units due to improper component placement preventing sterilization. The affected packs were distributed in Arkansas, Colorado, and Georgia.

    Product
    (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS; (2) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546D, 6 kits per case, contains BD Chloraprep Hi-Lite…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V136000·2023-03-01

    Ferrari Recalls SF90 Models for Passenger Air Bag Child Seat Risk

    Ferrari is recalling 2021-2023 SF90 Stradale and 2022 SF90 Spider vehicles because the passenger air bag may impact a child seat, increasing injury risk.

    Product
    FERRARI — FERRARI SF90 STRADALE, SF90 SPIDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0385-2023·2023-03-01

    Cashew Crave Mix recalled due to undeclared milk and soy allergens

    Nature's Eats Cashew Crave Mix 8 oz. is recalled for undeclared milk and soy allergens. The allergens are present in the product but not declared in the main 'Contains' statement.

    Product
    Nature's Eats Cashew Crave Mix 8 oz. UPC 8-10087-30330-3, packaged in cello bags 12 packages per case
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0330-2023·2023-03-01

    Tacrolimus Capsules Recalled for Wrong-Strength Tablets Co-Mingled in Bottles

    Dr. Reddy's Laboratories is recalling Tacrolimus 0.5 mg capsules due to the presence of one 1 mg capsule co-mingled in affected bottles. The mismatched capsule could lead to incorrect dosing in immunosuppressed patients.

    Product
    TACROLIMUS — TACROLIMUS (TACROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1144-2023·2023-03-01

    Hologic Mammography Systems Recalled for Unexpected C-Arm Movement

    Hologic is recalling 797 units of its 3Dimensions/Selenia Dimensions mammography systems nationwide due to unexpected C-arm movement that may cause blunt trauma.

    Product
    Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0364-2023·2023-03-01

    Pilgrim's Roasted Nut'Z Chocolate Espresso Beans recalled for undeclared soy

    Pilgrim's Roasted Nut'Z Tri-Colored Chocolate Espresso Beans are recalled due to undeclared soy lecithin. Consumers with soy allergies may experience allergic reactions.

    Product
    Pilgrim's Roasted Nut'Z Tri-Colored Chocolate Espresso Beans are packaged by hand into either the 8 oz Plastic Cone Bags or 8 Oz Pouch Bags. Label declares Espresso Beans, Dark Chocolate, Milk Chocolate, Marbled White Chocolate.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1158-2023·2023-03-01

    IV Access Device Kit Recalled Due to Manufacturing Defect in Connector

    Cardinal Health is recalling Presource Packs IV START TRAY I kits due to a manufacturing defect in the ICU MicroClave Clear Connector that may cause fluid leaks and loss of fluid path integrity.

    Product
    Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0336-2023·2023-03-01

    Levothyroxine Oral Solution TIROSINT Recalled Due to Subpotency

    IBSA PHARMA is recalling TIROSINT (levothyroxine sodium) oral solution due to subpotency in specific batches. The affected product may contain less active ingredient than labeled.

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V134000·2023-03-01

    Airstream travel trailers recalled for cooktop gas leak fire risk

    Airstream is recalling 2021-2023 travel trailers with SDS2 cooktops. Burner tubes may fracture and cause gas leaks, increasing fire risk. Dealers will install a support bracket at no charge.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE, BASECAMP, BAMBI, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0341-2023·2023-03-01

    Thyroid Drug TIROSINT Recalled Due to Subpotent Formulation

    IBSA Pharma Inc. recalls TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotent formulation containing less active ingredient than labeled.

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0338-2023·2023-03-01

    Thyroid Medication TIROSINT Levothyroxine Sodium Nationwide Recall for Subpotency

    IBSA Pharma Inc. is recalling TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotency. Two lot numbers are affected: Lot #220407 (Exp. 10/2023) and Lot #220960 (Exp. 03/2024).

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1164-2023·2023-03-01

    Luminos Agile Diagnostic Imaging System Collision Risk Recall

    Siemens recalls Luminos Agile imaging systems that may collide with ceilings or walls due to default configuration settings, potentially causing serious injury to staff or patients.

    Product
    Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1161-2023·2023-03-01

    Sterile Oncology Port Access Tray Recalled for Sterilization Failure

    Medline is recalling sterile oncology port access trays in which some components were not properly sterilized due to improper placement during manufacturing. Healthcare facilities should immediately discontinue use of affected units.

    Product
    Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2023·2023-03-01

    Hepatitis B Diagnostic Test Kits Recalled for Test Interference

    Siemens is recalling ADVIA Centaur diagnostic test kits used to detect hepatitis B antibodies due to test interference that can produce false positive results when performed before another hepatitis B test on the same sample.

    Product
    ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2-21 years old) and adult serum, EDTA plasma, or lithium heparin.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0345-2023·2023-03-01

    Prescription Levothyroxine Sodium Oral Solution Nationwide Recall Due to Subpotency

    IBSA Pharma has recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency. Affected lots 220418 and 220560 may contain insufficient active ingredient for proper thyroid hormone replacement therapy.

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0346-2023·2023-03-01

    FDA Recalls Sodium Chloride Injection Due to Incomplete Container Seals

    B. Braun Medical's 0.9% Sodium Chloride Injection batches recalled due to risk of incomplete seals that could allow leakage, potentially compromising sterility. The recall affects 1,343,982 bags distributed nationwide.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2023·2023-03-01

    HydroMID Peripheral Access Kit Recalled for Mislabeled Packaging

    Access Vascular is recalling the HydroMID 4Fr Single Lumen Maximal Barrier Kit because the outer bag and inner Tyvek header bag are mislabeled. The device is used for short-term peripheral venous access.

    Product
    HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0365-2023·2023-03-01

    Pilgrim's Roasted Nut'Z White Chocolate Raspberry Cashews recalled for undeclared allergens

    Pilgrim's Roasted Nut'Z White Chocolate Raspberry Cashews are recalled due to undeclared milk and soy lecithin. The product was distributed in California, Oregon, and Washington.

    Product
    Pilgrim's Roasted Nut'Z White Chocolate Raspberry Cashews are packaged by hand into either the 8 oz Plastic Cone Bags or 8 Oz Pouch Bags. Label declares Cashews, Sugar, White Chocolate Cocoa Powder (contains dairy), Vanilla Powder, Raspberry Syrup.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0362-2023·2023-03-01

    Pilgrim's Roasted Nut'Z Hazelnuts Recalled for Undeclared Milk

    Pilgrim's Roasted Nut'Z Garlic, Parmesan, Cracked Black Pepper Hazelnuts are recalled due to undeclared milk, a major allergen.

    Product
    Pilgrim's Roasted Nut'Z Garlic, Parmesan, Cracked Black Pepper Hazelnuts are packaged by hand into either the 8 oz Plastic Cone Bags or 8 Oz Pouch Bags. Label declares Hazelnuts, Sugar, Rehydrated Garlic, Cracked Black Pepper, Parmesan Cheese.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0340-2023·2023-03-01

    FDA Recalls TIROSINT Levothyroxine Sodium Lot 220853 for Subpotency

    IBSA Pharma Inc. recalled TIROSINT levothyroxine sodium lot 220853 nationwide due to subpotency. The oral solution may contain less active ingredient than labeled, potentially affecting thyroid hormone replacement therapy.

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0335-2023·2023-03-01

    Prescription Thyroid Medication TIROSINT Recalled for Subpotent Dosages Nationwide

    IBSA Pharma is recalling certain lots of TIROSINT (levothyroxine sodium) oral solution nationwide because the product contains less active ingredient than labeled. Patients using affected lots may not receive adequate thyroid hormone replacement.

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1157-2023·2023-03-01

    IV START KIT Connector Defect May Cause Fluid Leaks

    Cardinal Health's Presource Packs IV START KIT is being recalled due to a manufacturing defect in the connector that may cause fluid leaks and compromise intravenous fluid delivery.

    Product
    Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
    Category
    Medical Device
    Distribution
    Distributed nationwide