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.

17176–17200 of 53124

  • HighFDA (Food)·F-1091-2022·2022-06-08

    Potato and Cheese Pierogi Recalled for Undeclared Milk and Wheat

    Dymski Pierogi LLC is recalling potato and cheese pierogi products due to undeclared milk and wheat allergens. Affected products were distributed to retail stores, restaurants, and distribution centers in NJ, MA, and PA.

    Product
    Potato and Cheese Pierogi Grandma s Cuisine Potato-Cheese Pierogi UPC: 7 1375737813 0 & 8 67355 0030 3lb/3 dozen & 14oz (397g)/1dozen Bernat s Potato & Cheese 16oz (450g) Golden Eagle Potato and Cheese Pierogis UPC: 0 94922 10425 0 16oz Zuzanna s Potato-Cheese Pierogi 16 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0969-2022·2022-06-08

    Succinylcholine Chloride Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center LLC is recalling succinylcholine chloride injection due to lack of sterility assurance. The recall involves 181,560 pre-filled syringes distributed nationwide.

    Product
    Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-920-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2022·2022-06-08

    Busse Nerve Block Tray Swabs Recalled for Test Method Validation Uncertainty

    Busse Hospital Disposables is recalling Nerve Block Tray kits containing swab drug products due to uncertainty regarding adequate validation of test methods during manufacturing. The recall involves 250 units distributed nationwide.

    Product
    Nerve Block Tray Catalog Number: 3764R2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2022·2022-06-08

    Bio-Rad Sickle Cell Testing Software CD-ROM Defect Overwrites Custom Settings

    Bio-Rad is recalling Resin Update CD-ROM software (Model 250-3020) for the VARIANT nbs Sickle Cell Program because the update procedure overwrites custom laboratory settings, potentially causing incorrect pattern assignment in tested samples.

    Product
    Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Drugs)·D-0973-2022·2022-06-08

    Losartan Potassium Tablets Recalled for Elevated AZIDO Impurity Levels

    Strides Pharma Inc. is recalling Losartan Potassium 50 mg tablets distributed nationwide due to AZIDO impurity levels exceeding acceptable FDA manufacturing standards.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V402000·2022-06-08

    Keystone Coachworks Recalls 2020-2021 Mercedes Metris Vans for Gas Leak Risk

    Keystone Coachworks is recalling 2020-2021 Mercedes-Benz Metris Custom Camper Vans because damaged burner control valves may cause a gas leak, increasing fire risk.

    Product
    KEYSTONE COACHWORKS — KEYSTONE COACHWORKS MERCEDES METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0967-2022·2022-06-08

    Phenylephrine HCl Injection Recalled Due to Sterility Assurance Failure

    Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide because the manufacturer cannot assure the product met sterility standards required for injectable medications.

    Product
    Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1099-2022·2022-06-08

    Frozen Spinach-Feta Pierogis Recalled for Undeclared Milk Allergen

    DYMSKI PIEROGI LLC is recalling spinach-feta pierogis (865 units) because they contain undeclared milk, a common allergen not disclosed on labels. Products were distributed to retail stores, restaurants, and distribution centers in NJ, MA, and PA.

    Product
    Spinach-Feta Pierogi Grandma s Cuisine Spinach-Feta Pierogi UPC: 8 67355 00037 2 14oz (397g) / 1 dozen Golden Eagle Spinach & Feta Pierogis 16 oz (454g) Bernat s Spinach and Feta Cheese 16oz (450g)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1170-2022·2022-06-08

    Sterile Epidural Tray Recalled Due to Validation Uncertainty

    Busse Hospital Disposables is recalling Sterile Epidural Trays nationwide due to uncertainty about whether test method validation was adequate. No illnesses or injuries have been reported.

    Product
    Sterile Epidural Tray Catalog Number: 6259R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1093-2022·2022-06-08

    Frozen Food Recall: Mini Potato-Cheddar Pierogi Due to Undeclared Milk

    DYMSKI PIEROGI LLC is recalling Mini Potato-Cheddar Pierogi due to the presence of undeclared milk. Individuals with milk allergies may be affected by this product.

    Product
    Mini Potato-Cheddar Pierogi Grandma s Cuisine Mini Potato-Cheddar Pierogi UPC:7 05105 70390 9 3lb/3 dozen
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0955-2022·2022-06-08

    Glycopyrrolate Injection Recalled Due to Sterility Assurance Failure

    Nephron Sterile Compounding Center recalls glycopyrrolate injection (1 mg/5 mL, preservative-free) due to lack of assurance of sterility. Approximately 32,550 pre-filled syringes from lot GL2002B have been distributed nationwide.

    Product
    Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1198-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Manufacturing Test Validation Issue

    Busse Hospital Disposables is recalling Busse Convenience kits containing swab/swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation.

    Product
    SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0965-2022·2022-06-08

    Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. Approximately 57,810 syringes were distributed nationwide.

    Product
    Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1102-2022·2022-06-08

    Dawson Belgian Style Waffle Mix Recalled for E. coli Contamination

    Dawson Food Products is recalling Belgian Style Waffle Mix that tested positive for E. coli at low levels. Consumers should not consume the affected product.

    Product
    Dawson Food Products Belgian Style Waffle Mix, 5 lbs. bag, bag UPC 758162120844, item code D6000A0; 6, 5 lbs. bags per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1158-2022·2022-06-08

    Nerve Block Tray Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables recalled Nerve Block Tray units (catalog #8415) containing swab components due to uncertainty about adequate test method validation. The recall affects 420 units distributed nationwide.

    Product
    Nerve Block Tray Catalog Number: 8415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1135-2022·2022-06-08

    Delta 8 Gummy Edibles Recalled for Undeclared Soy and Coconut Allergens

    TWISTED BRANDS LLC is recalling Cosmic Crunch Bites By Twisted Delta 8 edibles due to undeclared soy lecithin and coconut oil, which may pose a serious allergy risk to consumers with these allergies.

    Product
    Cosmic Crunch Bites By Twisted, Delta 8 1000mg 25 mg per piece, 40 pieces 446g
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1202-2022·2022-06-08

    Convenience Kits With Swab Drug Products Recalled for Test Validation Failure

    Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to inadequate validation of manufacturing test methods.

    Product
    Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1101-2022·2022-06-08

    Keto Living Sugar Control Recalled: Undeclared Wheat in Gluten-Free Product

    Natural Organics, Inc. is recalling 4,650 bottles of Keto Living Sugar Control nationwide and internationally due to undeclared wheat in a product labeled gluten-free. Consumers with wheat allergies or celiac disease should not use this product.

    Product
    Keto Living Sugar Control
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1145-2022·2022-06-08

    Peritoneal Dialysis Extension Sets Recalled for Missing FDA Clearance

    Baxter Healthcare Corporation is recalling 3.65 m peritoneal dialysis extension sets from Lot H19G12025 that were distributed without FDA regulatory clearance. The devices were distributed in error and should not be used.

    Product
    3,65 m Extension Set with Luer-lock Connector
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1094-2022·2022-06-08

    Potato-Cheddar-Jalapeno Pierogi Recalled for Undeclared Milk Allergen

    Grandma's Cuisine Potato-Cheddar-Jalapeno Pierogi is recalled for containing undeclared milk, an allergen. The product was distributed to retailers and restaurants in New Jersey, Massachusetts, and Pennsylvania.

    Product
    Potato-Cheddar-Jalapeno Pierogi Grandma s Cuisine Potato-Cheddar-Jalapeno Pierogi UPC: 8 67355 00043 3 16 oz (454g) / 1 dozen
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1222-2022·2022-06-08

    Medical Device Recall: DYNEX Agility Analyzer Control Sample Aspiration Defect

    Dynex Technologies is recalling the DYNEX Agility Analyzer (Model 67000) due to a software defect that could cause control samples from the wrong SmartKit to be used during testing, potentially leading to delayed patient results.

    Product
    DYNEX Agility, Agility Analyzer, Model No. 67000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1186-2022·2022-06-08

    Busse Pellet Insertion Tray Kits Recalled for Manufacturing Validation Issues

    Busse Hospital Disposables is recalling Pellet Insertion Tray Kits due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.

    Product
    4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2022·2022-06-08

    Organ Preservation Device Recalled Due to Incomplete Weld Seal

    XVIVO Perfusion AB is recalling the XVIVO Organ Chamber REF 19020 due to an incomplete weld seal on the primary pouch that prevents sterility assurance. Approximately 80 devices were distributed in the U.S. and internationally.

    Product
    XVIVO Organ Chamber REF 19020
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-1100-2022·2022-06-08

    Wegmans lobster bisque recalled due to inadequate food safety controls

    Wegmans Food You Feel Good About Lobster Bisque is being recalled because its HACCP food safety plan was not fully implemented. No illnesses have been reported.

    Product
    Wegmans Food You Feel Good About Lobster Bisque - 16 oz packaged in a 4 x 4 x 3.75" clear plastic tub with a snap on lid.
    Category
    Food
    Distribution
    6 states