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.

9701–9725 of 27206

  • HighFDA (Devices)·Z-2746-2024·2024-09-04

    Medline procedural kits recalled due to defective plastic syringes

    Medline is recalling procedural kits with defective syringes due to leaks and breakage that may pose patient health risks. Affected products include biopsy packs, circumcision trays, and breast biopsy kits.

    Product
    Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2) CIRCUMCISION TRAY, Pack Number CIT7210; 3) CIRCUMCISION TRAY, Pack Number DYNDA2271; 4) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 5) UCLA - BREAST BIOPSY KITDYNDH1512A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2769-2024·2024-09-04

    Medline Centurion Procedure Kits Recalled for Syringe Leaks and Breakage

    Medline Industries is recalling Centurion procedure kits with plastic syringes affected by an FDA Safety Alert. The syringes may leak, break, or develop quality issues that could pose risks to patient health.

    Product
    Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100
    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-2750-2024·2024-09-04

    Medline Procedural Kits with Defective Plastic Syringes Recalled

    Medline procedural kits contain plastic syringes affected by an FDA Safety Alert. The syringes may leak or break, posing risks to patients during medical procedures.

    Product
    Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOPLASTY PACK-LF , Pack Number DYNJ38988J; 4)FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179A; 5) FREE FLAP TRAM ADD ON PACK, Pa
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2732-2024·2024-09-04

    Custom Orthopedic Surgical Implant Does Not Match Design Specifications

    A custom-made orthopedic surgical implant was supplied for a surgical procedure that did not match the design specifications. This mismatch could affect the proper fit and function of the device during surgery.

    Product
    Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
    Category
    Medical Device
    Distribution
    0 states
  • 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-2886-2024·2024-09-04

    BVI CustomEyes Procedure Packs containing Sol-M Syringes Recalled Nationwide

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M-manufactured syringes. The recall affects 138 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001579;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2768-2024·2024-09-04

    Medline Centurion Procedure Kits Recalled for Syringe Leaks and Breakage

    Medline Industries is recalling multiple Centurion procedure kit models due to plastic syringe defects including leaks and breakage that may pose a risk to patient safety. The affected kits were distributed worldwide.

    Product
    Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020; 3) 6" FEMORAL ARTERIAL LINE KIT, Pack Number ART245B; 4) ADVANCED REPAIR KIT, Pack Number SUT15940; 5) ARTHROGRAM TRAY, Pack Numbe
    Category
    Medical Device
    Distribution
    0 states
  • 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-2751-2024·2024-09-04

    Medline Procedural and Medical Kits Recalled for Defective Syringes

    Medline is recalling procedural kits worldwide containing plastic syringes with identified leaks and breakage. The defective syringes were identified in an FDA Safety Alert from March 19, 2024, and may pose risks to patients.

    Product
    Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417A; 3) DRAWER 9L , Pack Number ACC010427A; 4) MEDICATION DELIVERY MODULE, Pack Number ACC010605 ; 5) DRAWER 3, Pack Number
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2759-2024·2024-09-04

    Medline Procedural Kits Recalled for Syringe Quality Defects

    Medline is recalling NEURO TRAY procedural kits (Pack DYNJ55909B, Lot 23IBB122) due to plastic syringe defects including leaks and breakage that may pose a risk to patient health.

    Product
    Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2748-2024·2024-09-04

    Medline Fetal Surgery Kits Recalled Due to Defective Plastic Syringes

    Medline Industries is recalling procedural kits containing plastic syringes that may leak or break. The syringes were identified in a March 2024 FDA Safety Alert and may pose a risk to patient health.

    Product
    Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2) FETAL SURGERY CDS-LF, Pack Number CMPJ26754O
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2798-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes

    Beaver Visitec International voluntarily recalled BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 69 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000162;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-2725-2024·2024-09-04

    Stryker surgical bur may overheat and cause thermal tissue damage

    Stryker iBur surgical burs may overheat during use in neurosurgery and spine surgery, potentially causing thermal tissue damage requiring medical intervention. Approximately 2,507 units were distributed worldwide.

    Product
    Stryker iBur 3.0mm 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 (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 (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 (Devices)·Z-2754-2024·2024-09-04

    Medline Procedural Kits with Defective Syringes Recalled Worldwide

    Medline procedural kits with defective plastic syringes are recalled due to risks of leaks and breakage. The affected syringes were flagged in an FDA safety alert and may compromise patient safety during medical procedures.

    Product
    Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A
    Category
    Medical Device
    Distribution
    0 states
  • 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 (Food)·F-1756-2024·2024-09-04

    NOW Real Foods Brazil Nuts Recalled for Mold and Yeast Contamination

    NOW Real Foods Whole & Unsalted Raw Brazil Nuts are recalled due to high levels of mold, yeast, and microbial contamination. The recall affects 7,854 units distributed nationwide and to Singapore.

    Product
    NOW Real Foods Whole & Unsalted Raw Brazil Nuts 12oz. bag UPC 733739070128
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2792-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Voluntary Recall

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The recall affects 35 units with Part Number 584770 and is classified as FDA Class II.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584770;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2630-2024·2024-09-04

    Medline dialysis procedure packs recalled for syringe leaks and breakage

    Medline procedure packs containing Shenli syringes are being recalled due to leaks, breakage, and quality issues that may pose risks to patient health. The recall involves 1,679,067 units distributed worldwide.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ91
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2720-2024·2024-09-04

    Medical Device: Ion Endoluminal System Recalled for Instrument Arm Screw Failure

    Intuitive Surgical is recalling the Ion Endoluminal System due to potential screw failure in the instrument cart arm, which could cause uncontrolled catheter motion in patient airways.

    Product
    Ion Endoluminal System, REF: 380748-65
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2767-2024·2024-09-04

    Medical procedure kits with defective plastic syringes recalled due to quality issues

    Medline Industries is recalling Centurion procedure kits due to plastic syringes with defects including leaks and breakage. These defects may compromise patient safety during medical procedures.

    Product
    Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) ARTHROGRAPH TRAY, Pack Number MNS12670A; 5) BIOPSY SKIN/LACER
    Category
    Medical Device
    Distribution
    0 states