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 →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

11601–11625 of 27206

  • HighFDA (Devices)·Z-1708-2024·2024-05-08

    Zirconium oxide dental blocks recalled for cracking risk

    IVOCLAR VIVADENT is recalling 2,472 units of IPS e.max ZirCAD CER/in. Prime dental material blocks because defects may cause cracks during sintering, risking fracture in the patient's mouth.

    Product
    IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2024·2024-05-08

    Stryker Distal Access Catheter recalled for out-of-specification endotoxin contamination

    Stryker Neurovascular is recalling 43 units of Distal Access Catheter Lot 0000486382 due to out-of-specification endotoxin results. The affected lot was distributed across 12 states.

    Product
    The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2024·2024-05-08

    POWERSEAL surgical sealer malfunction causes incomplete seal cycle

    Olympus POWERSEAL surgical sealers may fail to deliver energy upon activation, resulting in incomplete seal cycles and surgical delays. Affected devices display an error tone and message instead of completing the sealing function.

    Product
    POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1721-2024·2024-05-08

    Zimmer Periarticular Locking Plate May Fail to Secure Fracture Fixation

    Zimmer's periarticular locking plates may fail to properly secure surgical fixation due to a thread-form defect. The defect could result in loss of fixation requiring further surgical intervention.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0479-2024·2024-05-08

    EYLEA injection recalled for sterility concerns and syringe breakage complaints

    Regeneron Pharmaceuticals recalled over 251,000 EYLEA (aflibercept) injection syringes distributed nationwide due to complaints of syringe breakage and concerns about sterility assurance in specific lots.

    Product
    EYLEA — EYLEA (AFLIBERCEPT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2024·2024-05-08

    RayStation radiation therapy system dosing parameter recall

    RayStation 15.0.0.430 radiation therapy planning system may have an elevated SSD parameter. Users should contact Raysearch Laboratories AB for corrective guidance.

    Product
    RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0477-2024·2024-05-08

    Methylergonovine Maleate tablets recalled for failed dissolution specifications

    Amneal Pharmaceuticals recalls Methylergonovine Maleate 0.2mg tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially reducing medication effectiveness.

    Product
    METHYLERGONOVINE MALEATE — METHYLERGONOVINE MALEATE (METHYLERGONOVINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1717-2024·2024-05-08

    Zimmer Periarticular Locking Plate recalled for improper screw mating defect

    Zimmer, Inc. is recalling the ZPLP Distal Lateral Fibular Plate due to a thread form defect that may prevent locking screws from properly mating with the plate, potentially causing surgical delays or loss of fixation.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1755-2024·2024-05-08

    Johnson & Johnson Irrigation Sleeve Recalled for Manufacturing Defect

    Johnson & Johnson is recalling 3,428 reusable irrigation sleeves due to manufacturing defects that could impair cooling during eye surgery, potentially causing anterior chamber instability and patient harm.

    Product
    Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1748-2024·2024-05-08

    Radiation Therapy Planning System May Calculate Skin Surface Distance Incorrectly

    RayStation radiation therapy planning software versions 11.0.0.951, 11.0.1.29, 11.0.3.116, and 11.0.4.15 may calculate skin surface distance (SSD) values incorrectly, potentially affecting dose calculations. Affected software has been distributed worldwide.

    Product
    RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0476-2024·2024-05-08

    FDA Issues Nationwide Recall of Subpotent Ophthalmic Eye Drops

    The FDA is recalling 3,320 bottles of compounded ophthalmic solution due to subpotency. The affected product does not contain adequate amounts of active medication.

    Product
    Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1213-2024·2024-05-08

    French's Crispy Fried Onions Recalled for Potential Staphylococcus Growth

    McCormick & Company is recalling French's Crispy Fried Onions due to potential growth of Staphylococcus aureus. The affected product was distributed to consumers in Arizona and Illinois.

    Product
    FRENCH S CRISPY FRIED ONIONS ORIG 16/6 OZ, Case Pack - 16/6 OZ,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1736-2024·2024-05-08

    Unsterilized Jackson-Pratt surgical drain kits recalled by Cardinal Health

    Cardinal Health recalls Jackson-Pratt 3-Spring Reservoir Kits because specific lots were shipped before sterilization. Unsterilized surgical devices pose risk of infection.

    Product
    Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2024·2024-05-08

    Zimmer Locking Plate System recalled due to thread mating defect

    Zimmer is recalling the ZPLP Distal Lateral Fibular Plate due to a thread form defect in the locking holes. Locking screws may not properly mate with the plate, potentially causing surgical delay or loss of fixation.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1749-2024·2024-05-08

    Radiation therapy planning system doses may be calculated incorrectly

    Certain versions of RayStation radiation therapy planning software may incorrectly report dose-related parameters, potentially affecting treatment calculations. The manufacturer recommends verification of affected systems.

    Product
    RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0480-2024·2024-05-08

    Fentanyl Injection Bags Recalled Due to Incorrect Barcode Labels

    Hikma Injectables USA Inc. has recalled 1,895 bags of Fentanyl 1000mcg/100mL injection (lot CH0324001) due to incorrect barcodes on the product labeling.

    Product
    Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0478-2024·2024-05-08

    Injectable epinephrine-lidocaine recalled for failing potency specification

    Imprimis NJOF, LLC is recalling epinephrine-lidocaine injectables nationwide because they failed to meet potency specifications. Patients should contact their healthcare provider regarding affected lots.

    Product
    Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0481-2024·2024-05-08

    Prescription Valacyclovir Tablets Recalled Due to Missing Imprint

    Viatris Inc is recalling 143,230 bottles of Valacyclovir Hydrochloride 500 mg tablets due to missing imprints on some tablets. The recall is nationwide and affects two lot numbers expiring in June 2024 and May 2025.

    Product
    VALACYCLOVIR HYDROCHLORIDE — VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1209-2024·2024-05-08

    Puerto Rican Wedding Cake Recall: Undeclared Food Dyes

    Reposteria Artesanal Laura is recalling Bizcocho de Boda Puertorriqueño cakes in Puerto Rico due to undeclared artificial food dyes (Red #40, Red #3, Yellow #5, Yellow #6, Blue #1, Blue #2).

    Product
    Bizcocho de Boda Puertorrique¿o Naked "Puerto Rican wedding cake naked", packaged in aluminum mold/plastic showcase, 24 Pack per case of 10 oz / 6 pack per case of 32 oz/ 4 pack per case of 51.2 oz, Net Wt. 10 oz UPC 851249003075, 32 oz. UPC 851249003112 and 52.2 oz UPC 85124900
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1612-2024·2024-05-01

    Route 92 Medical 070 Access System Recalled for Distal Tip Separation Risk

    Route 92 Medical 070 Access System catheters are recalled for potential distal tip separation during neurovasculature procedures. The defect affects 117 units distributed across 30 US states and New Zealand.

    Product
    Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • CriticalFDA (Drugs)·D-0459-2024·2024-05-01

    FDA Recalls Alcoholada Gel Pain Reliever Over Methanol Contamination

    Alcoholada Gel pain reliever is being recalled because the ethanol ingredient contains methanol contamination. The FDA classified this as a Class I recall affecting 9,625 bottles distributed nationwide.

    Product
    Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbe
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0453-2024·2024-05-01

    Male Sexual Enhancement Product Recalled for Undeclared Pharmaceutical Ingredients

    Pyramids Wholesale Inc. is recalling all lots of GoHARD 25000 because it contains undeclared sildenafil and tadalafil. The product was marketed without FDA approval for these prescription-strength drugs.

    Product
    GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2024·2024-05-01

    The GOAT Sublingual Strip Recalled for Undeclared Prescription Drug Ingredients

    The GOAT Sublingual Strip male enhancement product, distributed nationwide, was recalled for containing undeclared sildenafil and tadalafil. The product was marketed without FDA approval.

    Product
    The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0460-2024·2024-05-01

    FDA Recalls Aruba Aloe Hand Sanitizer for Methanol Contamination

    FDA is recalling 5,299 bottles of Aruba Aloe Hand Sanitizer Gel nationwide due to methanol contamination in the ethanol ingredient. Consumers should stop using the product immediately.

    Product
    Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5
    Category
    Drug
    Distribution
    Distributed nationwide