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.

14101–14125 of 53090

  • HighFDA (Drugs)·D-0403-2023·2023-03-08

    Phenylephrine Hydrochloride Injection recalled due to manufacturing practice deviations

    Accord Healthcare is recalling Phenylephrine Hydrochloride Injection vials due to manufacturing practice deviations discovered during an FDA inspection. Affected batches were distributed in the United States, Puerto Rico, and Canada.

    Product
    Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; NDC 16729-466-03, UPC 3 16729 46603 5
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1195-2023·2023-03-08

    Vascular Diagnostic Device Recalled for Risk of Air Line Misconnection

    Unetixs Vascular recalls MultiLab Series II ROODRA vascular diagnostic devices due to luer fittings that may allow air line misconnection to intravenous lines, potentially causing air embolism.

    Product
    MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2023·2023-03-08

    Medical Device Middleware: MYLA Software Fails to Apply AST Filter Rules

    Biomerieux MYLA laboratory middleware may fail to apply activated antibiotic susceptibility test (AST) filter rules when sending results to clinicians. The defect affects VITEK MS users with versions 4.8.x and 4.9.

    Product
    MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0397-2023·2023-03-08

    Prescription Glycopyrrolate Injection Recalled Due to Manufacturing Process Deviations

    Accord Healthcare is recalling Glycopyrrolate Injection due to manufacturing process deviations found during FDA inspection. The recall involves 5,273 vials distributed across the United States, Puerto Rico, and Canada.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0415-2023·2023-03-08

    FDA Recalls Tadalafil Tablets Due to Manufacturing Practice Deviations

    Accord Healthcare's Tadalafil 5 mg tablets are being recalled due to deviations from current good manufacturing practices identified during an FDA inspection. Approximately 1,113,264 bottles were distributed across the United States, Puerto Rico, and Canada.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0387-2023·2023-03-08

    Peanut Butter Hot Chocolate Recalled Due to Undeclared Peanut Allergen

    Corim Industries is recalling Peanut Butter Hot Chocolate and Peanut Butter Cappuccino products in multiple formats due to an undeclared peanut allergen. Consumers with peanut allergies should not consume these products.

    Product
    Cocoa de Aroma, 24 ct single serve coffee pods assorted (12.7 oz carton containing Peanut Butter flavor 0.52 oz. single serve coffee pods)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1181-2023·2023-03-08

    Ti-Cron Surgical Sutures Recalled Due to Sterile Barrier Breach

    Covidien is recalling Ti-Cron Coated Braided Polyester Sutures due to a sterile barrier breach in the breather pouch. The defect could allow bacterial contamination, posing a risk of infection or vision loss during ophthalmic procedures.

    Product
    Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0379-2023·2023-03-08

    FDA recalls Buspirone Hydrochloride tablets for manufacturing practice deviations

    Accord Healthcare is recalling approximately 25,812 bottles of Buspirone Hydrochloride 30mg tablets due to manufacturing practice deviations discovered during an FDA inspection.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1176-2023·2023-03-08

    Sofsilk Coated Braided Silk Sutures recalled for sterile barrier breach

    Covidien is recalling Sofsilk Coated Braided Silk Sutures due to a sterile barrier breach in the breather pouch. The breach may cause infection or vision loss during ophthalmic procedures involving direct patient contact.

    Product
    Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1186-2023·2023-03-08

    Triton Canister Software Labeling May Cause Inaccurate Blood Loss Estimates

    Stryker is recalling Triton Canister Software due to labeling issues that may cause inaccurate blood loss estimates. This could delay recognition of or prolong postpartum hemorrhage, potentially requiring more aggressive treatment.

    Product
    Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0377-2023·2023-03-08

    FDA Recalls Accord Healthcare Buspirone 15 mg Tablets for Manufacturing Deviations

    Accord Healthcare is recalling 10,992 bottles of Buspirone Hydrochloride 15 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing quality control deviations found during an FDA inspection.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0411-2023·2023-03-08

    Simvastatin 40 mg tablets recalled for manufacturing practice deviations

    Accord Healthcare is recalling 1,190,484 bottles of Simvastatin 40 mg tablets distributed in the United States, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations identified during an FDA inspection.

    Product
    SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1203-2023·2023-03-08

    FDA Recalls Mobile X-Ray System for Erratic Movement Risk

    SEDECAL's Phoenix mKDR Xpress mobile x-ray system is recalled due to three reported incidents of erratic movements. Seven units distributed in the US, Argentina, and Panama are affected.

    Product
    Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0359-2023·2023-03-08

    Nephron Phenylephrine HCl Injection Recalled for Sterility Assurance

    Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. The recall affects 546,450 vials distributed nationwide.

    Product
    Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1202-2023·2023-03-08

    Phoenix mKDR Mobile Diagnostic X-ray System Recalled for Erratic Movements

    SEDECAL SA is recalling 53 units of the Phoenix mKDR mobile diagnostic x-ray system following 3 incidents of erratic movements. Facilities using the affected equipment should discontinue use and contact the manufacturer.

    Product
    Phoenix mKDR, digital mobile diagnostic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1184-2023·2023-03-08

    Stryker Blood Loss Estimator Inserts Recalled for Inaccurate Measurement

    Stryker is recalling Medivac Guardian 2L blood loss estimator inserts and labels for measurement inaccuracy. The device may output incorrect estimates, potentially delaying postpartum hemorrhage treatment.

    Product
    Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2023·2023-03-08

    Dental Handpieces Recalled Due to Detachable Screw Component Risk

    Coltene Whaledent Inc is recalling SciCan STATIS SL S10001 dental handpieces because the screw connection between the turbine head and push button may loosen and fall off, creating a risk of swallowing or inhaling these parts.

    Product
    SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0390-2023·2023-03-08

    Peanut Butter Hot Chocolate and Cappuccino Recall for Undeclared Peanut Allergen

    Corim Industries recalls Peanut Butter Hot Chocolate and Peanut Butter Cappuccino in multiple formats due to undeclared peanut allergen. Consumers with peanut allergies should not consume these products.

    Product
    Colonial Coffee, 12 ct single serve coffee pods (4.44 oz. carton)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1172-2023·2023-03-08

    Dermalon Surgical Sutures recalled for sterile barrier breach

    Covidien is recalling Dermalon monofilament nylon sutures due to a breach in the sterile barrier of the breather pouch. Affected units may cause infection or vision loss if used in ophthalmic procedures involving direct patient contact.

    Product
    Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88861757-41 DERMALON* 3-0 BLU 75CM C13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0398-2023·2023-03-08

    Safe + Fair Popcorn Recalled for Undeclared Peanut Residue

    Safe + Fair Food Company's Key Lime Pie Drizzled Popcorn is being recalled due to the potential presence of undeclared peanut residue. Consumers with peanut allergies should not consume this product.

    Product
    The Safe + Fair Food Company Key Lime Pie Drizzled Popcorn Kettle Popped Net Wt. 7.5 oz (212g) Packaged in a plastic bags
    Category
    Food
    Distribution
    10 states
  • HighFDA (Drugs)·D-0417-2023·2023-03-08

    Tadalafil Tablets Recalled Due to Manufacturing Practice Deviations

    Accord Healthcare recalls Tadalafil 20 mg tablets due to CGMP deviations identified during FDA inspection. Approximately 613,553 bottles distributed in the US, Puerto Rico, and Canada are affected.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0357-2023·2023-03-08

    FDA Recalls Norepinephrine Injection Due to Sterility Concerns

    Nephron Sterile Compounding Center is recalling Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance. The recall affects 305,895 bottles across 13 lots.

    Product
    Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0397-2023·2023-03-08

    Safe & Fair popcorn product recalled due to undeclared peanut residue

    Snack Innovations Inc. is recalling Safe & Fair 7.5 oz drizzled popcorn Honey Crisp Apple Pie due to potential undeclared peanut residue. The product was distributed across multiple U.S. states.

    Product
    Safe & fair 7.5 oz drizzled popcorn Honey Crisp Apple Pie Packaged in a plastic bags
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0389-2023·2023-03-08

    Peanut Butter Hot Chocolate and Cappuccino Recalled for Undeclared Peanut Allergen

    Corim Industries is recalling Agglomerated Peanut Butter Hot Chocolate and Peanut Butter Cappuccino products due to undeclared peanut allergen. People with peanut allergies who consume these products may experience allergic reactions.

    Product
    Jersey Charm, 24 ct single serve coffee pods (12.7 oz. carton)
    Category
    Food
    Distribution
    4 states