The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

1201–1225 of 26417

  • LowFDA (Devices)·Z-1503-2026·2026-03-18

    Penner Pacific Bathing Spa recalled for missing unique device identifier

    Penner Patient Care is recalling 206 units of Penner Pacific Bathing Spa because the devices do not bear a unique device identifier (UDI) on their labeling.

    Product
    Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1508-2026·2026-03-18

    Penner Pacific Bathing Spa Recalled for Missing Device Identifier

    Penner Patient Care is recalling 26 units of the Penner Pacific Bathing Spa Model 860010-1L because the device lacks a required unique device identifier. The product was distributed nationwide.

    Product
    Penner Pacific Bathing Spa, Model Numbers 860010-1L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·H-0545-2026·2026-03-18

    C2O Coconut Water with Pulp 15-pack with incorrect outer box labels

    The outer cardboard box of C2O Coconut Water with Pulp (17.5 oz) 15-packs contains incorrect Nutrition Facts and Ingredient Lists that fail to disclose 5g of added sugar per can, although the can itself has correct labeling.

    Product
    C2O Coconut Water with Pulp (17.5 oz) 15 Pack UPC: 8-50274-00792-8
    Category
    Food
    Distribution
    11 states
  • LowFDA (Devices)·Z-1504-2026·2026-03-18

    Penner Pacific Bathing Spa units recalled due to missing device identifier

    Penner Patient Care is recalling 158 units of Penner Pacific Bathing Spa devices nationwide. The devices lack the required unique device identifier designation.

    Product
    Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1505-2026·2026-03-18

    Penner Pacific Bathing Spa units lack required unique device identifier

    Penner Patient Care recalled 25 units of Penner Pacific Bathing Spa models 390010-1, 390010-X, and 390010-2 due to missing unique device identifiers.

    Product
    Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1507-2026·2026-03-18

    Penner Pacific Bathing Spa Recalled for Missing Device Identifier

    Penner Patient Care is recalling 190 Penner Pacific Bathing Spa units (models 760010-1 and 770010-1) because they do not bear the required unique device identifier.

    Product
    Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1506-2026·2026-03-18

    Penner Pacific Bathing Spa recalled for missing unique device identifier

    Penner Patient Care, Inc. is recalling Penner Pacific Bathing Spa units because the devices do not bear a unique device identifier.

    Product
    Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1502-2026·2026-03-18

    Penner Pacific Bathing Spa recalled for missing unique device identifier

    Penner Patient Care, Inc. is recalling 45 units of the Penner Pacific Bathing Spa (Model 360020-1P) distributed nationwide due to missing unique device identifiers (UDI).

    Product
    Penner Pacific Bathing Spa, Model Numbers 360020-1P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0396-2026·2026-03-11

    Capsules with Undeclared Prescription Drugs Marketed Without FDA Approval

    Mojo Max Fusion XXX capsules contain undeclared sildenafil and tadalafil, prescription drugs marketed without FDA approval. All lots (exp. 12/31/2027) distributed nationwide should not be used.

    Product
    Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1469-2026·2026-03-11

    Impella RP cardiac support device sensor malfunction recall

    Abiomed is recalling 291 Impella RP cardiac support devices because the differential pressure sensor may malfunction, causing sensor values to drift. Devices were distributed worldwide.

    Product
    Impella RP with SmartAssist. Product Code: 0046-0035.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0397-2026·2026-03-11

    MR. 7 SUPER 700000 Capsules Recalled for Undeclared Pharmaceutical Ingredients

    MR. 7 SUPER 700000 capsules distributed to 4 U.S. customers contain undeclared sildenafil and tadalafil and were marketed without FDA approval. Consumers who have this product should discontinue use and consult a healthcare provider.

    Product
    MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·H-0620-2026·2026-03-11

    Lobster and Crab Ravioli recalled for undeclared allergens

    Perfect Pasta, Incorporated is recalling Lobster & Crab Ravioli due to undeclared shrimp, crab, lobster, pollock, whiting, and soy. The product was distributed to consignees in Utah only.

    Product
    Lobster & Crab Ravioli. Keep Frozen. Contains: Wheat, Eggs, Milk, Crustaceans-Shellfish. Product is intended to be further cooked. Weight: 1-10 pound (4.5g). Use within 6 months. 801-541-9292-www.FunarosPerfectPasta.com. 1391 So. 300 West Slc, Ut 84115.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1470-2026·2026-03-11

    Impella RP Flex heart pump recalled for sensor malfunction risk

    Abiomed is recalling the Impella RP Flex cardiac assist device because its differential pressure sensor may malfunction and drift, potentially affecting device function. The FDA classified this as a Class I recall.

    Product
    Impella RP Flex with SmartAssist. Product Code: 1000323.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0388-2026·2026-03-11

    Unapproved herbal supplement contains undeclared meloxicam pain medication

    SILINTAN 25 pills, sold nationwide, contain meloxicam but lack FDA approval. The manufacturer sold the product without the required drug application.

    Product
    SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1471-2026·2026-03-11

    Abiomed Impella RP Devices Recalled for Differential Pressure Sensor Malfunction

    Abiomed is recalling 179 Impella RP devices worldwide due to a differential pressure sensor that may malfunction and cause sensor values to drift. The FDA has classified this as a Class I recall.

    Product
    Impella RP. Product Code: 0046-0011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0384-2026·2026-03-11

    FDA recalls Temozolomide 5mg capsules for quality failures

    Rising Pharma is recalling 1,200 bottles of Temozolomide 5mg capsules (lot 1TM0524003A) nationwide due to out-of-specification impurities and degradation detected during stability testing.

    Product
    TEMOZOLOMIDE — TEMOZOLOMIDE (TEMOZOLOMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0393-2026·2026-03-11

    Semaglutide Injectable Vial Recalled Due to Lack of Sterility Assurance

    Semaglutide injectable vials (lot 240903) are being recalled due to lack of sterility assurance. The product was distributed in Ohio with expiration 9/30/2026.

    Product
    Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0394-2026·2026-03-11

    Tirzepatide 10mg Injectable Vials Recalled for Sterility Assurance Issues

    New Life Pharma LLC is recalling 23 vials of Tirzepatide 10mg injectable due to lack of assurance of sterility. The affected batch (Lot 240709) was distributed in Ohio.

    Product
    Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0363-2026·2026-03-11

    Max Packaging Antibacterial Towelettes Recalled for Manufacturing Deviations

    ACME United Corporation is recalling Max Packaging Antibacterial Towelettes (NDC 59647-750-01) due to manufacturing practice deviations. Specific lot numbers are affected nationwide.

    Product
    Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0379-2026·2026-03-11

    Semaglutide Compounding Powder Recalled for Failed Process Validation

    Harbin Jixianglong Biotech's semaglutide compounding powder is recalled nationwide for failing to complete process validation and bacterial endotoxin testing before distribution. No illnesses have been reported.

    Product
    Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0356-2026·2026-03-11

    Metoprolol Succinate Tablets Recalled for Failed Dissolution Specifications

    Teva Pharmaceuticals is recalling 7,448 bottles of Metoprolol Succinate Extended-Release 100 mg tablets nationwide due to failed dissolution specifications. The defect could result in inadequate drug absorption. Contact your pharmacist if you have affected lots.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1484-2026·2026-03-11

    Urine Albumin Diagnostic Test Produces Falsely Low Results

    Siemens is recalling Atellica CH Urine Albumin test kits due to measurement error producing falsely low results. Samples with urine albumin above 40.0 mg/dL may report 6.2-40.0 mg/dL, affecting 4,885 units worldwide.

    Product
    Atellica CH Urine Albumin (UAlb). Material Number: 11537225
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1483-2026·2026-03-11

    B. Braun Tissue Expander Injection Needles Recalled for Defective Needle Tips

    B. Braun has recalled 51,300 units of its 21GA Winged Infusion Set due to potential needle defects. The needle tips may be dull, blunt, difficult to advance, or prone to breaking during use.

    Product
    Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1476-2026·2026-03-11

    Medical Diagnostic Analyzer Software Defect Causes Erroneous Lab Results

    A software defect in Roche's cobas pro automated diagnostic analyzer allows erroneous calibrations, causing the system to repeat previous results instead of calculating new values, potentially leading to incorrect patient lab results.

    Product
    cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystati
    Category
    Medical Device
    Distribution
    Distributed nationwide