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.

1126–1150 of 88106

  • HighFDA (Devices)·Z-2919-2026·2026-08-19

    V-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects

    FDA is recalling V-Loc 180 Absorbable Wound Closure Devices due to potential sterile barrier packaging defects that could lead to biocontamination.

    Product
    V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2937-2026·2026-08-19

    Bioporto ProNephro AKI Reagent Kit Recalled for Non-Validated Rework Process

    Bioporto Diagnostics is recalling ProNephro AKI Reagent Kits because a non-validated rework process could lead to missed diagnoses of renal disease.

    Product
    ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2941-2026·2026-08-19

    BD Medical Extension Sets Recalled for Potential Sterilization Defects

    BD Switzerland is recalling 93,700 intravascular extension sets because they may not have received adequate sterilization processing.

    Product
    60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Intravascular Administration Set and…
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2918-2026·2026-08-19

    V-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects

    Covidien, LP is recalling V-Loc 90 Absorbable Wound Closure Devices due to potential sterile barrier packaging defects that may cause biocontamination.

    Product
    V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM0024 V-LOC* 90 3-0 CLR 45CM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2926-2026·2026-08-19

    Medline Micro-Kill Bleach Germicidal Wipes Recalled for Reduced Concentration

    Medline Industries is recalling Micro-Kill Bleach Germicidal Wipes because bleach concentration may drop below specification, potentially compromising disinfection effectiveness.

    Product
    Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2921-2026·2026-08-19

    Surgipro Sutures Recalled for Potential Sterile Barrier Perforation

    FDA is recalling Surgipro sutures due to potential sterile barrier defects that could cause biocontamination and infection.

    Product
    Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2949-2026·2026-08-19

    Cardinal Health Presource Kits Recalled for Endotoxin Variability

    Cardinal Health is recalling 616 Presource Kits because they contain sponges with unexpected endotoxin variability.

    Product
    Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2934-2026·2026-08-19

    Waldemar Link Recalls Endo-Model Tibial Plateau Replacement Sets

    Waldemar Link is recalling Endo-Model tibial plateau replacement sets that incorrectly contain a Pure Hinge plateau, posing a risk of increased wear if implanted.

    Product
    Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2948-2026·2026-08-19

    Cardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges

    Cardinal Health 200, LLC is recalling 52,699 Presource surgical kits because they contain MEDICOM Ritmed Neurological Sponges with unexpected endotoxin variability.

    Product
    Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2912-2026·2026-08-19

    Microvention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects

    Microvention Inc. is recalling 5,500 Bobby Balloon Guide Catheters worldwide due to an increased rate of balloon pinhole defects.

    Product
    BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2924-2026·2026-08-19

    Medline Bleach Wipes Recalled for Reduced Disinfection Effectiveness

    Medline is recalling Micro-Kill Bleach Germicidal Wipes because reduced bleach concentration may compromise disinfection effectiveness, potentially allowing pathogenic microorganisms to survive.

    Product
    Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2928-2026·2026-08-19

    Philips Allura Xper FD Fluoroscopic X-Ray System Recalled for Firmware Issue

    Philips is recalling 4,252 Allura Xper FD interventional fluoroscopic x-ray systems worldwide due to a firmware issue that may cause loss of geometry movements.

    Product
    Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2943-2026·2026-08-19

    Cardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges

    Cardinal Health is recalling Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.

    Product
    Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2932-2026·2026-08-19

    Philips Azurion Fluoroscopy System Recall for Software Image Quality Issues

    Philips is recalling 2,016 Azurion interventional fluoroscopic x-ray systems worldwide due to software defects that may degrade image quality or lose geometry movements, potentially delaying therapy or causing procedural complications.

    Product
    Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2947-2026·2026-08-19

    Cardinal Health Recalls Neurological Procedure Kits Due to Endotoxin Variability

    Cardinal Health is recalling specific Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.

    Product
    Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2C; 4) CHI STD NEURO CRANI OPT 2 , Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2944-2026·2026-08-19

    Cardinal Health Presource Kits Recalled for Endotoxin Variability

    Cardinal Health is recalling Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.

    Product
    Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2925-2026·2026-08-19

    Medline Bleach Wipes Recalled for Reduced Disinfection Effectiveness

    Medline is recalling bleach wipes that may lose potency before expiration, potentially allowing pathogens to survive.

    Product
    Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2923-2026·2026-08-19

    Medline Bleach Wipes Recalled for Reduced Disinfection Effectiveness

    Medline Industries is recalling Micro-Kill Bleach Germicidal Wipes because reduced bleach concentration may compromise disinfection effectiveness.

    Product
    Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2931-2026·2026-08-19

    Philips Azurion Rystem X-Ray System Software Recall for Image Quality Issues

    Philips is recalling Azurion Rystem X-ray systems due to software defects that may degrade image quality or lose geometry movements, potentially delaying therapy or causing procedural complications.

    Product
    Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10*…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2945-2026·2026-08-19

    Cardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges

    Cardinal Health is recalling Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.

    Product
    Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2946-2026·2026-08-19

    Cardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges

    Cardinal Health is recalling 602 Presource surgical kits because they contain MEDICOM Ritmed Neurological Sponges with unexpected endotoxin variability.

    Product
    Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0761-2026·2026-08-19

    Shoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations

    Shoolin Pharma Chem LLP is recalling Tadalafil USP 0.500 KG bags due to Current Good Manufacturing Practice (CGMP) deviations noted during an FDA inspection.

    Product
    TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2936-2026·2026-08-19

    BioFire Respiratory Panel 2.1 Recalled for Increased False Negative Results

    BioFire Diagnostics is recalling 2,370 pouches of the BIOFIRE Respiratory Panel 2.1 test due to an increase in false negative results.

    Product
    BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2933-2026·2026-08-19

    OBP Medical Recalls Vaginal Speculums Due to Potential Sharp Edges

    OBP Medical is recalling ER-Spec Single-Use Vaginal Speculums because a burr on the plastic blade may create a sharp edge, posing a risk of injury to patients and providers.

    Product
    OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0760-2026·2026-08-19

    Shoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations

    Shoolin Pharma Chem LLP is recalling Tadalafil USP 0.100 KG bags due to Current Good Manufacturing Practice (CGMP) deviations noted during an FDA inspection.

    Product
    TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.
    Category
    Drug
    Distribution
    Distributed nationwide