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.

17201–17225 of 53124

  • HighFDA (Drugs)·D-0951-2022·2022-06-08

    Calcium Gluconate Injection Syringes Recalled for Sterility Assurance

    Nephron Sterile Compounding Center is recalling 30,180 pre-filled Calcium Gluconate Injection syringes due to lack of sterility assurance. Affected lots CG1003A and CG2001A were distributed nationwide.

    Product
    Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0954-2022·2022-06-08

    Fentanyl Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center has recalled 3,532 bags of fentanyl citrate injection due to lack of sterility assurance. The affected lots (FN1088A and FN1089A) were distributed nationwide.

    Product
    Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1090-2022·2022-06-08

    Ardent Mills Whole Wheat Flour Recalled for Stainless Steel Contamination

    Ardent Mills is recalling BBU Fine Whole Wheat Flour and SG Whole Wheat Fine Flour due to potential contamination with small pieces of stainless steel from milling equipment discovered during inspection.

    Product
    BBU Fine Whole Wheat Flour Bulk-AA-50251, Bulk Tanker; SG Whole Wheat Fine Flour 2,000 lb. Tote-AA Storage instructions - Any product made from raw agricultural commodities, such as wheat, rye and other grains, may be subject to infestation if not properly inspected when…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0968-2022·2022-06-08

    Rocuronium Bromide Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Rocuronium Bromide Injection pre-filled syringes nationwide due to lack of sterility assurance. Approximately 604,080 syringes are affected.

    Product
    Rocuronium Bromide Injection, 50 mg/5 mL (10 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: 69374-924-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0950-2022·2022-06-08

    Sodium Bicarbonate Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling approximately 13,612 units of 8.4% Sodium Bicarbonate Injection due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0960-2022·2022-06-08

    Ketamine Hydrochloride Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Ketamine Hydrochloride Injection due to lack of assurance of sterility. The recall affects 107,530 pre-filled syringes distributed nationwide.

    Product
    Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 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: 69374-982-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1188-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty

    Busse Hospital Disposables is recalling convenience kits containing swab and swabstick products due to uncertainty regarding the adequacy of manufacturing test method validation. Affected lot numbers are 2110127 and 2110269.

    Product
    SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1209-2022·2022-06-08

    da Vinci Vessel Sealer May Fail to Adequately Seal Tissue

    Intuitive Surgical is recalling da Vinci Vessel Sealer instruments worldwide because placing excessive tissue in the instrument jaws can result in an insufficient seal. Surgeons should follow proper technique guidelines when using the device.

    Product
    VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2022·2022-06-08

    Busse Convenience Kit Swab Products Recalled Due to Manufacturing Test Validation Issue

    Busse Convenience kits containing swab/swabstick products manufactured by Professional Disposables International have been recalled due to uncertainty about the adequacy of manufacturing test method validation.

    Product
    SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2022·2022-06-08

    Busse Convenience Kits Recalled: Drug Swabs Face Manufacturing Validation Uncertainty

    Professional Disposables International's swab and swabstick drug products, sold in Busse Convenience kits, are recalled due to uncertainty about whether manufacturing validation test methods were adequate.

    Product
    Nerve Block Tray Catalog Number: 6796R3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1172-2022·2022-06-08

    Single Shot Epidural Tray recalled due to inadequate test method validation

    Busse Hospital Disposables is recalling Single Shot Epidural Trays because swab components from Professional Disposables International were manufactured with unvalidated test methods.

    Product
    Single Shot Epidural Tray Catalog Number: 6797R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2022·2022-06-08

    Swab Drug Products Recalled Due to Manufacturing Validation Uncertainty

    Convenience kits containing swab/swabstick drug products are being recalled due to uncertainty about whether test methods used during manufacturing adequately validated the products. Affected products include 80 units distributed nationwide.

    Product
    Epidural Tray Catalog 1577
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1106-2022·2022-06-08

    Wisco Pop Strawberry Soda Recalled for Possible Yeast Contamination

    Karben4 Brewing LLC is recalling Wisco Pop Strawberry Soda because cans may contain yeast. The product was distributed in Illinois, Minnesota, and Wisconsin.

    Product
    Wisco Pop Strawberry Soda, 12 FL OZ. 355 ML, UPC 50037-32406. Handcrafted for Wisco pop Bev. Co. Madison, WI 53704
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1201-2022·2022-06-08

    Swab drug products recalled due to inadequate test method validation

    Busse Hospital Disposables is recalling convenience kits containing swab drug products manufactured by Professional Disposables International due to uncertainty about the adequacy of test methods used in manufacturing.

    Product
    Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2022·2022-06-08

    Busse Hospital Disposables Recalls Convenience Kits with Swab Products

    Busse Hospital Disposables is recalling Convenience kits containing swab products due to uncertainty about manufacturing validation adequacy. The kits were distributed nationwide.

    Product
    Pellet Insertion Tray Catalog Number: B1654
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0970-2022·2022-06-08

    Equate Tartar Control Plus Mouthwash Recalled for Out-of-Specification Formula

    Walmart is recalling Equate Tartar Control Plus mouthwash from certain lots because they were found to have active ingredients outside the approved specification.

    Product
    Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouthrise Plus, Antigingivitis/Antiplaque, Blue Mint, 1.5 Liter (50.7 FL OZ) bottle, Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 14800…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1160-2022·2022-06-08

    Nerve Block Tray Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Nerve Block Trays containing swab and swabstick products due to uncertainty about manufacturing test method validation. Affected lot numbers should be discontinued.

    Product
    Nerve Block Tray Catalog Number: 9342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1206-2022·2022-06-08

    Medtronic cardiac catheter system recalled due to sterility barrier defect

    Medtronic recalls its C304-HIS cardiac catheter device due to potential sterility barrier defects in certain manufacturing lots. Approximately 1,385 devices distributed worldwide were affected.

    Product
    The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V404000·2022-06-08

    2020-2022 Porsche Taycan center screen display malfunction increases crash risk

    Porsche is recalling 2020-2022 Taycan vehicles for a software error causing the center screen and touch panel to go black or flicker. This blocks the driver's view of rear-view camera functions, increasing crash risk.

    Product
    PORSCHE — PORSCHE TAYCAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0956-2022·2022-06-08

    Glycopyrrolate Injection Recalled Due to Lack of Sterility Assurance

    Nephron is recalling 6,150 units of Glycopyrrolate Injection due to lack of sterility assurance. Healthcare providers should stop using affected lots and contact their supplier for return instructions.

    Product
    Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2022·2022-06-08

    Core Biopsy Tray Recall Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Core Biopsy Trays (Catalog 8673R4) distributed nationwide because the test methods used to validate manufacturing processes may not have been adequately validated. The affected 285 units may lack proper quality verification.

    Product
    Core Biopsy Tray Catalog Number: 8673R4
    Category
    Medical Device
    Distribution
    Distributed nationwide