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 →

76–100 of 633

  • HighFDA (Devices)·Z-2217-2026·2026-05-27

    Medtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier

    Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula Model 94665 due to potential sterile barrier breach. The product is used in cardiopulmonary bypass procedures worldwide.

    Product
    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2214-2026·2026-05-27

    Medtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall

    Medtronic is recalling certain lots of GUNDRY Retrograde Cannula (Model 94113T), a cardiopulmonary bypass catheter, due to potential sterile barrier breach in the product.

    Product
    Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2026·2026-05-27

    Philips Azurion X-Ray Systems Table Movement Control Defect Recall

    Philips Azurion X-ray imaging systems may experience impaired table movement due to mechanical wear in the Float Tabletop control. The control module defect could affect longitudinal and transverse table positioning during medical procedures.

    Product
    Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2203-2026·2026-05-27

    Swan-Ganz Jr Catheter models recalled due to lumen hub leakage

    Becton, Dickinson and Company is recalling Swan-Ganz Jr Catheters (models SGPT54, SGPT64P, SGPT755P) because the blue proximal injectate lumen hub may leak or break due to manufacturing changes, risking infection, medication loss, and blood loss.

    Product
    Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0835-2026·2026-05-27

    Good & Gather Mexican Street Corn Trail Mix Recalled for Potential Salmonella

    John B Sanfilippo & Sons Inc is recalling Good & Gather Mexican Street Corn Trail Mix 8 oz bags due to potential Salmonella contamination. Consumers should not consume the product and should dispose of it or return it to the retailer.

    Product
    Good & Gather Mexican Street Corn Trail Mix 8 oz bag UPC 085239270240, 8 bags per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0836-2026·2026-05-27

    Fisher Tex Mex Trail Mix Recalled for Potential Salmonella Contamination

    Fisher Tex Mex Trail Mix 30 oz jars are recalled nationwide due to potential Salmonella contamination. Consumers should not consume the product and should dispose of it or return it to the retailer.

    Product
    Fisher Tex Mex Trail Mix 30 oz plastic jar UPC 070690275941, 6 jars per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2220-2026·2026-05-27

    Medtronic DLP Retrograde Cannula 13FR Model 94913L Recall

    Medtronic is recalling certain lots of DLP Retrograde Cannula (Model 94913L), a cardiopulmonary bypass catheter, due to potential sterile barrier breaches. The affected device was distributed worldwide.

    Product
    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2204-2026·2026-05-27

    Swan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk

    Becton, Dickinson and Company is recalling Swan-Ganz Pacing Catheter Model D200F7 due to a manufacturing defect that may cause the proximal injectate lumen hub to leak or break, potentially leading to infection, medication loss, or blood loss.

    Product
    Swan-Ganz Pacing Catheter, Models: D200F7;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2026·2026-05-27

    Medtronic DLP Retrograde Cannula cardiopulmonary bypass catheter

    Medtronic is recalling certain lots of its DLP Retrograde Cannula (Model 94915), a cardiopulmonary bypass vascular catheter, due to potential sterile barrier breach.

    Product
    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2209-2026·2026-05-27

    Tangent Single Use Digital Catheter Recalled for Distal Shaft Fractures

    Tangent Endoscopy is recalling its Tangent Single Use Digital Catheter (models TNG4002-IND and TNG-4007-6pk) due to fractures observed at the distal shaft tip without complete detachment, posing a risk during endoscopic procedures.

    Product
    Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0831-2026·2026-05-27

    Southern Style Nuts Gourmet Hunter Mix Recalled for Salmonella Risk

    John B Sanfilippo & Sons Inc is recalling Southern Style Nuts Gourmet Hunter Mix due to potential Salmonella contamination. The recall affects 23 oz and 36 oz jars distributed nationwide.

    Product
    Southern Style Nuts Gourmet Hunter Mix 23 oz plastic jar UPC 085839073319 and 36 oz plastic jar UPC 085839071483. 23 oz 6 jars per case case and 96 jars per display. 36 oz 6 jars per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2026·2026-05-27

    Azurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage

    The deaeration hose in Philips Azurion X-ray tube cooling units may degrade over time and leak oil, affecting cooling performance and automatically triggering low-dose fluoroscopy mode.

    Product
    Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2219-2026·2026-05-27

    Medtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall

    Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94913), a cardiopulmonary bypass vascular catheter, due to a potential sterile barrier breach.

    Product
    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0534-2026·2026-05-27

    Primidone Tablets Recalled Due to API Cross-Contamination

    Golden State Medical Supply Inc. is recalling Primidone 50 mg tablets due to cross-contamination of the active pharmaceutical ingredient with trace amounts of Acemetacin API. The recall affects 8,526 bottles distributed nationwide.

    Product
    PRIMIDONE — PRIMIDONE (PRIMIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2213-2026·2026-05-27

    OneLIF Interbody Cage Inserter Attachment Failure Recall

    Novapproach Spine is recalling OneLIF Interbody Cages because the straight inserter may fail to properly attach to the cages, potentially causing procedural delays or the need to use an alternative implant.

    Product
    OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree 14mm X 11mm, 010-107-1613/Small 7 Degree 16mm X 13mm, 010-113-1006/Small,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2222-2026·2026-05-27

    Medtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach

    Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94965) due to potential sterile barrier breach. The cannula is used in cardiopulmonary bypass procedures.

    Product
    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0543-2026·2026-05-27

    Estradiol Gel Packets Recalled for Empty or Partially Full Containers

    ANI Pharmaceuticals is recalling Estradiol Gel 0.1% (Lot M251109) distributed nationwide because some packets were found to be either empty or partially full.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2226-2026·2026-05-27

    Silastic Brand Foley Catheters recalled due to surface stain

    C.R. Bard Inc is recalling Silastic Brand Foley Catheters because of stain present on the surface of affected units. The recall affects 106,160 catheters distributed across the United States and Canada.

    Product
    Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Food)·H-0809-2026·2026-05-27

    Vitamin B-Complex, C & Folic Acid Dietary Supplement Recalled for Foreign Matter

    Llorens Pharmaceuticals is recalling Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement due to black particulate matter contamination. The product was distributed across multiple US states and Puerto Rico.

    Product
    Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Amber PET modern round 24-400 bottle, 47 SERVING PER BOTTLE, 24 bottles- 8 FL Oz (237mL) Amber PET modern round bottles per package, Store at room. Mnfg by: Llorens Pharmaceutical Miami, FL
    Category
    Drug
    Distribution
    24 states
  • ModerateFDA (Drugs)·D-0548-2026·2026-05-27

    Fentanyl Citrate Sterile Injection Recalled for Subpotent Drug Content

    IntegraDose Compounding Services LLC is recalling fentanyl citrate sterile injection (2,500 mcg/50mL) distributed nationwide due to subpotent drug content. The voluntary recall affects 376 cassettes with lot number 20260310FEN-1, expiration date 09/06/2026.

    Product
    fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2228-2026·2026-05-27

    Philips Allura X-ray Systems Deaeration Hose Degradation Recall

    Deaeration hoses in Philips Allura X-ray tube cooling units may degrade and leak oil, reducing cooling performance. Affected units were manufactured between February 2016 and May 2020.

    Product
    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 72
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0542-2026·2026-05-27

    Gas-X Simethicone 125 mg softgels recall for incomplete labeling

    Haleon is recalling Gas-X Simethicone 125 mg softgels due to incomplete inactive ingredient information on carton labeling.

    Product
    Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0549-2026·2026-05-27

    Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid

    Safecor Health is recalling a vitamin and mineral dietary supplement oral liquid due to the presence of black particles in the liquid. Affected lots were distributed in Ohio.

    Product
    Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0533-2026·2026-05-27

    Primidone Tablets Recalled Due to Cross-Contamination with Acemetacin

    Lannett Company Inc. is recalling Primidone 250mg tablets nationwide due to cross-contamination with trace amounts of Acemetacin in the active pharmaceutical ingredient. The recall affects 44,865 bottles distributed across the USA.

    Product
    PRIMIDONE — PRIMIDONE (PRIMIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide