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.

9626–9650 of 27089

  • HighFDA (Devices)·Z-2722-2024·2024-09-04

    Stryker iBur Surgical Bur Recalled Due to Excessive Temperature Risk

    Stryker recalls iBur 3.0mm Precision Round surgical burs due to potential for excessive temperatures where the bur shank meets the bushing. Thermal injury risk may require medical intervention.

    Product
    Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2731-2024·2024-09-04

    Stryker iBur 3.0mm surgical burr recalled over thermal hazard

    Stryker Corporation is recalling the iBur 3.0mm Precision Match Head surgical burr because it may generate higher-than-specified temperatures during use, potentially causing thermal injury that may require medical intervention.

    Product
    Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2718-2024·2024-09-04

    Nanoplasty 3D Bunion Implant System Recalled for Mechanical Failure Risk

    Treace Medical Concepts is recalling its Nanoplasty 3D Bunion Implant (Model SK57) nationwide due to potential mechanical failures where locking screws may strip or fail to seat properly. No injuries have been reported.

    Product
    Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0646-2024·2024-09-04

    Prescription Ibuprofen Tablets Recalled for Excessive Unknown Impurities

    Dr. Reddy's Laboratories is recalling IBU Ibuprofen 400 mg prescription tablets due to impurity levels exceeding specifications. The recall affects 14,940 bottles distributed nationwide in the USA and Puerto Rico.

    Product
    IBU — IBU (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1753-2024·2024-09-04

    Ground cinnamon recalled due to elevated lead levels

    Colonna Brothers Inc. is recalling Supreme Tradition and Marcum brand ground cinnamon distributed nationwide due to elevated lead levels.

    Product
    Ground cinnamon. Supreme Tradition brand ground cinnamon packaged in 2.25 oz clear plastics jars with black lids. UPC: 639277656377 Marcum brand ground cinnamon packaged in 1.5 oz clear plastic jars with black lids. UPC:051933364035
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2747-2024·2024-09-04

    Medline Procedural Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling multiple procedural kits containing plastic syringes that may leak, break, or have quality defects. These defects may pose a risk to patient health during surgical procedures.

    Product
    Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4) EAR PACK, Pack Number CMPJ05884J; 5) MZ EAR PACK , Pack Number CMPJ09860D; 6) KIT MAJOR EAR CHRG, Pack
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2752-2024·2024-09-04

    Medline surgical procedure kits recalled due to defective plastic syringes

    Medline is recalling surgical procedure kits containing plastic syringes that may leak or break. The kits were distributed worldwide and may pose a risk to patient health.

    Product
    Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCIS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2734-2024·2024-09-04

    Electrocardiograph Recall: CARDIOVIT AT-180 May Produce Signal Artifacts

    Schiller is recalling CARDIOVIT AT-180 electrocardiographs due to potential high-frequency signal artifacts during ECG acquisition that may affect diagnostic accuracy. 1,084 units are affected worldwide.

    Product
    CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2839-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Recall

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain Sol-Millennium Medical syringes that are subject to a manufacturer recall. A total of 103 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001025;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2024·2024-09-04

    Immunoassay analyzer software may delay test processing with automation systems

    A software issue in DxI 9000 Access analyzers connected to laboratory automation systems may prevent processing of all samples, flagging tests as timed out and potentially delaying patient results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2723-2024·2024-09-04

    Stryker iBur 4.0mm surgical bur recall: excessive heat risk during bone surgery

    Stryker iBur 4.0mm precision surgical burs may overheat where the shank meets the distal bushing. Excessive heat could cause minor tissue damage or thermal injury requiring medical intervention.

    Product
    Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2776-2024·2024-09-04

    Centurion Procedure Packs with Plastic Syringes Recalled for Leaks and Breakage

    Medline Industries is recalling Centurion procedure packs containing plastic syringes due to leaks, breakage, and quality defects that may pose a risk to patient health. The affected products are distributed worldwide.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack Number MNS11965A; 3) ARTHROGRAPH TRAY, Pack Number MNS12670A; 4) BREAST BIOPSY KIT, Pack Number DYNDH1512; 5) CIRCUMCISION KIT, Pack Numbe
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2749-2024·2024-09-04

    Medline Circumcision Tray Kits Recalled for Defective Syringes

    Medline procedural kits containing circumcision trays are being recalled due to plastic syringes affected by an FDA Safety Alert. The syringes have identified leaks and breakage that may pose risks to patient health.

    Product
    Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2627-2024·2024-09-04

    Medline Procedure Packs With Syringes Recalled for Quality Defects

    Medline Industries has recalled over 1.6 million procedure packs containing syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected packs were distributed worldwide.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2724-2024·2024-09-04

    Stryker iBur 2.0mm Diamond Round Burr Thermal Hazard Recall

    Stryker recalled 1,226 iBur surgical burrs with multiple lot numbers worldwide due to potential overheating at the bur-shank connection point, which could cause tissue damage requiring medical intervention.

    Product
    Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1747-2024·2024-09-04

    La Superior Bakery Pan De Rancho Pastries Recalled for Undeclared Sesame

    La Superior Bakery is recalling Pan De Rancho pastries distributed in Alabama due to undeclared sesame allergen. Consumers with sesame allergies should not consume the product and should return it to the point of purchase.

    Product
    La Superior Bakery - Pan De Rancho packaged in clear plastic bag - 5 pastries per bag
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2631-2024·2024-09-04

    Medline procedure packs with syringes recalled due to leaks and breakage

    Medline Industries recalled procedure packs containing Shenli syringes due to leaks, breakage, and quality defects. The recalled units were distributed worldwide and may pose a risk to patient health.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2829-2024·2024-09-04

    Voluntary Recall of BVI CustomEyes Procedure Packs With Sol-M Syringes

    BVI CustomEyes Procedure Packs containing Sol-M manufactured low dead space and Luer Slip syringes are subject to a voluntary recall. Approximately 142 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000866;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2779-2024·2024-09-04

    Centurion Procedure Packs With Defective Syringes Recalled Worldwide

    Medline Industries is recalling Centurion procedure packs containing plastic syringes with identified leaks, breakage, and quality defects. The recall affects units distributed worldwide.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) CIRCUMCISION TRAY, Pack Number CIT6720; 3) CIRCUMCISION TRAY, Pack Number CIT6720A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2727-2024·2024-09-04

    Stryker iBur surgical burs recalled due to overheating risk

    Stryker Corporation recalls iBur 3.0mm surgical burs used in neurosurgery, spinal, and ENT procedures due to potential overheating at the bur-shank interface. The heat risk may cause tissue damage requiring medical intervention.

    Product
    Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2614-2024·2024-09-04

    Pediatric Tracheostomy Tubes Recalled Due to Defective Securement Flange

    Smiths Medical recalls pediatric tracheostomy tubes from specific lots due to a manufacturing defect that may cause the securement flange to tear. No injuries have been reported.

    Product
    a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRA
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2770-2024·2024-09-04

    Medical procedure kits recalled due to defective plastic syringes

    Medline's Centurion procedure kits are being recalled due to plastic syringes with leaks and breakage. The defective syringes may pose a risk to patient health during medical procedures.

    Product
    Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) FINE LACERATION KIT, Pack Number SUT17215; 4) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 5) LACERATION TRAY, Pack Number DYNDL1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2780-2024·2024-09-04

    Centurion Procedure Packs with Defective Syringes Recalled Worldwide

    MEDLINE INDUSTRIES is recalling Centurion procedure packs containing syringes with documented leaks, breakage, and other quality defects. The affected syringes may pose a risk to patient health during medical procedures.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2) CIRCUMCISION KIT, Pack Number CIT6535; 3) CIRCUMCISION KIT, Pack Number CIT7095; 4) CIRCUMCISION TRAY, Pack Number CIT6860A; 5) CIRCUMCISION TRAY, Pack N
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2898-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M syringes recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 123 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001649;
    Category
    Medical Device
    Distribution
    Distributed nationwide