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.

9751–9775 of 27206

  • 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-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-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 (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-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 (Food)·F-1757-2024·2024-09-04

    ALB Flavor cinnamon powder recalled for elevated lead levels

    ALB Flavor cinnamon powder is recalled due to elevated lead contamination. The product was distributed in NY, CT, MI, and MA and poses a serious health risk.

    Product
    ALB Flavor brand CINNAMON Powder; 100 g; ALB-USA Enterprises Inc 529 Bryant Av, Bronx, NY 10474; UPC 5 304000 333362; packaged in a plastic bag inside a brown carton box with an image of cinnamon powder and two cinnamon sticks centered at the bottom.
    Category
    Food
    Distribution
    4 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-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
  • 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-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-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-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-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 (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 (Drugs)·D-0647-2024·2024-09-04

    Ibuprofen Tablets Recalled Due to Failed Impurities and Degradation Specifications

    Preferred Pharmaceuticals is recalling 266 bottles of generic ibuprofen tablets due to failed impurities and degradation specifications discovered during stability testing. The affected lots were distributed in California and Nevada.

    Product
    Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
    Category
    Drug
    Distribution
    2 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-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-2728-2024·2024-09-04

    Stryker iBur Surgical Bur Recall Due to Excessive Heat Risk

    Stryker is recalling iBur 4.0mm Coarse Diamond surgical burs that may overheat during use. Excessive heat could cause tissue or bone damage requiring medical intervention.

    Product
    Stryker iBur 4.0mm 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-2632-2024·2024-09-04

    Medline procedure packs with Shenli syringes recalled for leaks and breakage

    Medline is recalling medical procedure packs containing Shenli syringes due to identified leaks, breakage, and quality issues. These kits may pose a risk to patient health during surgical procedures.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT BUNDLE 16CM, Part Number ECVC3260; 3) CENTRAL LINE INSERTION KIT, Part Number ECVC7440; 4) CENTRAL LINE INSERTION KIT, Part Number ECVC7445;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2743-2024·2024-09-04

    Medline procedural kit syringes recalled for leaks and breakage

    Medline Industries is recalling multiple surgical procedural kits containing plastic syringes with quality defects. The syringes may leak or break during use, posing a risk to patient safety.

    Product
    Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN HEART, Pack Number CDS983348AA; 4) OPEN HEART, Pack Number CDS983348X; 5) OPEN HEART, Pack Number CDS983348Y; 6) HMT CV SET UP CDS, Pack
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2629-2024·2024-09-04

    Medline Procedure Packs with Defective Syringes Recalled Worldwide

    Medline recalls approximately 1.7 million procedure packs containing defective Shenli syringes due to leaks and breakage that may pose patient risks. The syringes are affected by an FDA Safety Alert from March 2024.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • ModerateFDA (Devices)·Z-2719-2024·2024-09-04

    Cobra EMG ET Tube Recalled Due to Incorrect Size Labeling

    Neurovision Medical Products recalls Cobra 3-Plate EMG ET Tubes due to mislabeling with incorrect tube size on the label. The error could affect proper product selection in clinical procedures.

    Product
    Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2837-2024·2024-09-04

    BVI CustomEyes Procedure Packs recalled for containing Sol-M syringes

    Beaver Visitec International is recalling 1,955 units of BVI CustomEyes Procedure Packs nationwide because they contain Sol-M syringes subject to a voluntary recall by the manufacturer.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001019;
    Category
    Medical Device
    Distribution
    Distributed nationwide