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.

9601–9625 of 27089

  • HighFDA (Devices)·Z-2760-2024·2024-09-04

    Medline procedural kits recalled for syringe leaks and breakage

    Medline procedural kits contain plastic syringes with leaks and breakage that may pose health risks. The affected kits are used for delivery procedures and distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR OB DELIVERY , Pack Number DYNJ908583; 3) SR OB DELIVERY , Pack Number DYNJ908583A; 4) VAG DELIVERY, Pack Number DYNJ909097
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2729-2024·2024-09-04

    Stryker iBur surgical bur recalled for potential overheating at junction

    Stryker has recalled 1171 units of iBur 5.0mm surgical burs due to potential overheating at the bur shank junction. The overheating could cause thermal injury requiring medical intervention.

    Product
    Stryker iBur 5.0mm 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)/ Otorhinolaryngol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-2771-2024·2024-09-04

    Breast biopsy kits recalled due to defective syringes with leaks and breakage

    Medline Industries recalls Centurion breast biopsy procedure kits due to defective plastic syringes that may leak or break. The syringes are affected by an FDA safety alert and pose potential risks during medical procedures.

    Product
    Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number BT515A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2730-2024·2024-09-04

    Stryker iBur surgical bur may overheat during bone-cutting procedures

    Stryker iBur 3.0mm Diamond Match Head surgical cutting tools may reach temperatures exceeding safe operating limits during bone surgery, potentially causing thermal tissue injury. About 2,507 units worldwide are affected.

    Product
    Stryker iBur 3.0mm Diamond 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)/ Otorhinolaryngology
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2745-2024·2024-09-04

    Medline recalls three medical procedure kits with defective plastic syringes

    Medline is recalling three procedural kits containing plastic syringes with leaks and breakage issues that may pose a risk to patient health. The kits have been distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRAY W/O CATH, Pack Number PICCNC0004; 3) VASCATH INSERTION PACK, Pack Number, CVI4825
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2726-2024·2024-09-04

    Stryker iBur Diamond Round surgical bur recalled for thermal overheating risk

    Stryker iBur 4.0mm Diamond Round surgical burs may reach temperatures higher than specified, potentially causing thermal injury or tissue damage during bone-cutting procedures. Approximately 1,706 affected units have been distributed worldwide.

    Product
    Stryker iBur 4.0mm 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 (Drugs)·D-0644-2024·2024-09-04

    Prescription Ibuprofen Recalled Due to Failed Impurity Specifications

    Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg prescription tablets nationwide due to failed quality specifications. Testing found unknown impurities exceeding acceptable limits.

    Product
    IBU — IBU (IBUPROFEN)
    Category
    Drug
    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
  • HighFDA (Food)·F-1748-2024·2024-09-04

    La Superior Bakery Pan Guatemalteco Recalled for Undeclared Sesame

    La Superior Bakery is recalling Pan Guatemalteco pastries due to undeclared sesame seeds. Consumers with sesame allergies face risk of allergic reaction.

    Product
    La Superior Bakery - Pan Guatemalteco packaged in clear plastic bag - 5 pastries per bag
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1751-2024·2024-09-04

    Infant Formula Recalled Due to Excess Vitamin D Levels

    CVS Health and HEB Baby Premium Infant Formula with Iron is recalled due to vitamin D levels exceeding permitted maximums. The recall affects 16,500 units.

    Product
    CVS Health brand and HEB Baby brand Premium Infant Formula with Iron Milk-Based Powder; packaged in 964g composite cans; 4 cans per case; UPC 50428318034 and 41220164578
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-2623-2024·2024-09-04

    Medline procedure packs with syringes recalled due to leaks and breakage

    Medline is recalling procedure packs containing Shenli syringes due to leaks, breakage, and quality issues that may pose risks to patient health. Over 1.6 million units have been distributed worldwide.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC LOCAL PACK-LF, pack number DYNJ54607A, 3) LOCAL PACK, pack number DYNJ61839B
    Category
    Medical Device
    Distribution
    0 states
  • 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 (Devices)·Z-2744-2024·2024-09-04

    Medline Circumcision Kits Recalled Due to Defective Syringes

    Medline is recalling two circumcision tray kit models due to plastic syringes with leaks, breakage, and quality defects that may harm patients. The kits have been distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2625-2024·2024-09-04

    Medical Convenience Kits with Defective Plastic Syringes Recalled

    Medline Industries recalls medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose risks to patient health. About 1.6 million units were distributed worldwide.

    Product
    See RES Description
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2778-2024·2024-09-04

    Medline Centurion Procedure Packs with Syringes Recalled for Defects

    Medline has recalled Centurion procedure packs containing syringes due to leaks, breakage, and quality issues. These defects may pose a risk to patient health.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2765-2024·2024-09-04

    Medline Procedural Kits Recalled for Defective Plastic Syringes

    Medline Industries is recalling multiple procedural kits containing plastic syringes affected by an FDA Safety Alert. The syringes have quality issues including leaks and breakage that may pose a risk to patient health.

    Product
    Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pack Number DYNJ82317; 3) ARTHROGRAM, Pack Number DYNDH1446A ; 4) ARTHROGRAM TRAY, Pack Number DYNDH1648; 5) ARTHROGRAM TRAY, Pack Number PAIN1396 ; 6) AR
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2635-2024·2024-09-04

    Medline Medical Convenience Kits with Plastic Syringe Defects

    Medline is recalling approximately 1.68 million medical convenience kits with plastic syringes affected by leaks and breakage. The defects may pose a risk to patient health per an FDA Safety Alert issued March 19, 2024.

    Product
    Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack Number DYNDA2391; 3) BLOCK KIT , Pack Number DYNDA2508; 4) NERVE BLOCK PAIN PACK, Pack Number DYNDL1389; 5) BLOCK TRAY-LF , Pack Number DYNJ0117039; 6) NER
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2736-2024·2024-09-04

    Lab analyzer incorrectly configured for complex testing at waived facilities

    Five Afinion 2 lab analyzers were distributed with incorrect configuration, potentially allowing waived laboratories to perform moderately complex assays that could produce erroneous results.

    Product
    Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
    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-2756-2024·2024-09-04

    Medline Procedural Kits Recalled Due to Defective Plastic Syringes

    Medline Industries is recalling multiple procedural kits containing defective plastic syringes that may leak or break. The affected kits were distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 4) RETINAL INJECTION KIT, Pack Number MNS12465; 5) UCLA - BREAST BIOPSY KIT, Pa
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-2758-2024·2024-09-04

    Medline Medical Procedural Kits Recalled for Defective Plastic Syringes

    Multiple Medline procedural kits contain defective plastic syringes that may leak or break during medical procedures. The FDA has advised of potential patient health risks from these manufacturing quality issues.

    Product
    Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 3) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 4) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 5) STERI
    Category
    Medical Device
    Distribution
    0 states