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.

10851–10875 of 27206

  • HighFDA (Devices)·Z-2158-2024·2024-06-26

    Exactech OPTETRAK Knee Implants Recalled for Out-of-Specification Vacuum Bag Packaging

    Exactech is recalling OPTETRAK Advanced Patella knee implant components packaged in vacuum bags that did not meet manufacturing specifications. Improper packaging could compromise product sterility.

    Product
    OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2144-2024·2024-06-26

    VICRYL Sutures recalled due to packaging defect compromising sterility

    Ethicon recalls 341,532 units of VICRYL surgical sutures worldwide due to holes in primary packaging that compromise sterility and could result in infection.

    Product
    VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2161-2024·2024-06-26

    Xstar Safety Slit Knife Recalled for Incorrect Blade Bevel Orientation

    Beaver Visitec International is recalling the Xstar Safety Slit Knife Model 378227 because some units have the blade bevel installed incorrectly—facing downward instead of the intended upward orientation.

    Product
    Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2153-2024·2024-06-26

    Howmedica Gray Revision Instrument Tray Recalled for Design Enabling Instrument Reuse

    Howmedica is recalling the Gray Revision Instrument System Accessory Tray/Case due to a design flaw that may enable reuse and re-sterilization of single-use, sterile-packaged instruments.

    Product
    Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1379-2024·2024-06-26

    Snow White Chocolate Bulk Product Recalled for Potential Salmonella

    Clasen Quality Chocolate Inc. is recalling Snow White Chocolate bulk tanker product due to potential Salmonella contamination. The product was distributed across multiple states.

    Product
    Snow White Chocolate, Item #: 60949. Bulk tanker.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2145-2024·2024-06-26

    FDA Recalls VICRYL Plus Antibacterial Sutures Due to Packaging Defect

    Ethicon is recalling VICRYL Plus Antibacterial Sutures due to a packaging machine defect that created holes in the primary packaging, potentially compromising product sterility. Affected sutures may pose an infection risk.

    Product
    VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB94
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0557-2024·2024-06-26

    Little Remedies Gas Relief Drops Class II Recall for Manufacturing Deviations

    Denison Pharmaceuticals recalls 113,544 bottles of Little Remedies Gas Relief Drops (Lot #0855, exp. 8/31/2025) due to manufacturing deviations. All units have been recovered and controlled at the manufacturer.

    Product
    LITTLE REMEDIES — LITTLE REMEDIES (SIMTHICONE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2160-2024·2024-06-26

    NxStage PureFlow-B Hemodialysis Solution Bags Recalled Due to Bursting Chambers and Caustic Fluid

    NxStage PureFlow-B hemodialysis solution bags may burst during preparation, releasing caustic electrolyte fluid that can cause chemical burns. Affected units are distributed nationwide.

    Product
    NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2024·2024-06-26

    MONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect

    Ethicon recalls 306,000 MONOCRYL surgical sutures worldwide due to holes in primary packaging from a manufacturing defect that compromises sterility and could result in infection.

    Product
    MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2162-2024·2024-06-26

    Xstar Safety Slit Knife Recalled for Incorrect Blade Configuration

    Beaver Visitec International is recalling 126 Xstar Safety Slit Knives with incorrect blade configuration. The recalled knives have the bevel oriented to the back instead of the front.

    Product
    Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2024·2024-06-26

    PDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility

    Ethicon recalls PDS Plus Antibacterial sutures due to packaging defects that compromised sterility. The affected units may cause infection if used in surgery.

    Product
    PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0555-2024·2024-06-26

    FDA Recalls Dexamethasone Sodium Phosphate Injection Due to Impurity Specification Failure

    Eugia US LLC recalls 70,125 vials of Dexamethasone Sodium Phosphate injection due to failed impurity specifications. Testing found sulfonic acid adduct of dexamethasone phosphate exceeded allowed limits.

    Product
    DEXAMETHASONE SODIUM PHOSPHATE — DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1376-2024·2024-06-26

    Moore Family Farms Cheddar Cheese Curds recalled for E. coli contamination

    Moore Family Farms and Creamery Cheddar Cheese Curds are being recalled due to high coliform and E. coli levels. The recalled product was distributed in Iowa.

    Product
    Moore Family Farms and Creamery Cheddar Cheese Curds, 1 pound plastic bags, packaged with white ties
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1386-2024·2024-06-26

    Milk Chocolate Wafer recalled for potential Salmonella contamination

    Clasen Quality Chocolate Inc. is recalling Milk Chocolate Wafer (Item #51407) distributed in nine states due to potential Salmonella contamination.

    Product
    Milk Chocolate Wafer, Item # 51407 (R&D Sample).
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2149-2024·2024-06-26

    Ethicon MONOCRYL Plus Sutures Recalled for Packaging Defect

    Ethicon recalled 287,892 MONOCRYL Plus Antibacterial Sutures worldwide due to a packaging machine defect that created holes in primary packaging, potentially compromising sterility and risking infection.

    Product
    MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0562-2024·2024-06-26

    Prescription Drug Duloxetine Recalled for Nitrosamine Impurity Exceeding FDA Limits

    Breckenridge Pharmaceutical recalls Duloxetine 60mg capsules nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. Affected lots had current good manufacturing practice (CGMP) deviations.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0558-2024·2024-06-26

    OSSOS-SANS tablets recalled: undeclared diclofenac and methocarbamol found

    OSSOS-SANS Reforzado tablets are being recalled because they contain undeclared active pharmaceutical ingredients—diclofenac and methocarbamol—and were marketed without FDA approval.

    Product
    OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2024·2024-06-26

    Bard Foley Catheter Trays Recalled for Temperature Display Malfunction

    C.R. Bard Inc is recalling 6,420 Foley catheter trays nationwide because some devices may not display temperature readings or may display erratic readings. The malfunction could affect patient monitoring.

    Product
    Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2150-2024·2024-06-26

    TabloCart power cord connector may overheat in hemodialysis system

    Outset Medical is recalling 431 TabloCart hemodialysis system carts due to power cord connector defects that may cause overheating, sparks, and smoke, potentially delaying treatment or causing burns.

    Product
    TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1383-2024·2024-06-26

    Milk Chocolate Coating Recalled for Potential Salmonella Contamination

    Clasen Quality Chocolate Inc. is recalling Milk Chocolate Flavored IC Coating distributed in nine states due to potential Salmonella contamination. The product is sold in bulk tanker format for use in food manufacturing.

    Product
    1057556 Milk Chocolate Flavored IC Coating, Item # 56546. Bulk tanker.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2151-2024·2024-06-26

    Hospital bed mattress covers may delaminate from improper cleaning

    Baxter Healthcare is recalling Centrella Max and Pro+ hospital bed mattresses that may develop delaminated top covers when cleaned with bleach-containing solutions. The mattresses prevent and treat pressure injuries.

    Product
    Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max mattresses and pro+ mattresses. (1) Centrella Max Surface, REF P7922A01; (2) C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2024·2024-06-26

    Exactech Knee Patella Components Recalled Due to Out-of-Specification Vacuum Bags

    Exactech is recalling OPTETRAK Three Peg Patella knee components packaged in out-of-specification vacuum bags. The affected products were distributed worldwide.

    Product
    OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2146-2024·2024-06-26

    PDS II Polydioxanone Sutures Recalled Due to Compromised Sterility

    Ethicon is recalling 56,952 units of PDS II polydioxanone sutures distributed worldwide because a packaging defect resulted in compromised sterility, which could lead to infection. No illnesses have been reported.

    Product
    PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1381-2024·2024-06-26

    White Chocolate Wafer Recalled for Potential Salmonella Contamination

    Clasen Quality Chocolate Inc. is recalling 74,050 pounds of White Chocolate Wafer due to potential Salmonella contamination. The product was distributed to food service and ingredient suppliers across nine states.

    Product
    White Chocolate Wafer, Item # 59152. Net Wt. 50 lbs (22.68kg). Clasen Quality Chocolate 5126 West Terrace Drive, Madison, WI 53718
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2156-2024·2024-06-26

    OPTETRAK One Peg Patella components recalled for out-of-specification vacuum bags

    Exactech is recalling OPTETRAK One Peg Patella knee implants due to vacuum bags packaged below specification. The recall affects units with multiple lot numbers distributed worldwide.

    Product
    OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
    Category
    Medical Device
    Distribution
    0 states