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 →

426–450 of 26383

  • HighFDA (Devices)·Z-1948-2026·2026-05-06

    Medtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs

    Medtronic Sphere-9 Catheters used for cardiac ablation may trigger ventricular fibrillation during radiofrequency therapy in patients with Biotronik implantable defibrillators due to an interaction between catheter current flow and a device safety feature.

    Product
    Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2022-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin

    Medline is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may exceed specifications. Approximately 21,288 kits have been distributed worldwide.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS983493N; 2. TLIF PACK, Medline Kit Number/SKU DYNJ02476O; 3. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069N; 4. DONOR FREE
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2015-2026·2026-05-06

    Medline medical procedure kits recalled for elevated endotoxin levels

    Medline Industries is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels detected during an internal review. Affected kits include the Major Neuro Pack-LF, Angiography Pack, and Neuro SEO models.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X; 2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ51637D; 3. NEURO SEO, Medline Kit Number/SKU DYNJ65650.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0676-2026·2026-05-06

    [pending] 52USA brand POPPING BOBA; STRAWBERRY FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fruct

    Pending LLM rewrite. Source: FDA_FOOD H-0676-2026.

    Product
    52USA brand POPPING BOBA; STRAWBERRY FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carageenan (EE407), p
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1995-2026·2026-05-06

    Straumann n!ce Zr HT Dental Implant Abutments Recalled for Incorrect Screw Seat

    Straumann USA LLC is recalling 6 units of Straumann n!ce Zr, HT endosseous dental implant abutments (Article 010.0158) due to an incorrect screw seat interface that could affect proper implant function.

    Product
    Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2027-2026·2026-05-06

    Medline Medical Procedure Kits Recalled for High Endotoxin Levels

    Medline is recalling medical procedure kits containing neuro sponges due to higher-than-expected endotoxin levels that may be out-of-specification. The kits were distributed worldwide.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2009-2026·2026-05-06

    Medline Neuro Sponges in Pediatric Airway Kits recalled for endotoxin

    Medline Industries is recalling Pediatric Airway Procedure Kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may be out of specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2020-2026·2026-05-06

    Medline Medical Procedure Kits With Neuro Sponges Recalled

    Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may be out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO PA
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0679-2026·2026-05-06

    [pending] Negita Cracker- Shrimp 2.8oz

    Pending LLM rewrite. Source: FDA_FOOD H-0679-2026.

    Product
    Negita Cracker- Shrimp 2.8oz
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1960-2026·2026-05-06

    Philips Ingenia Ambition S MRI Systems Recalled for Stiffness Value Errors

    Philips is recalling certain Ingenia Ambition S MRI systems with MR Elastography software due to potential stiffness value errors that may occur when specific image reconstruction parameters are used in combination with Resoundant's algorithm.

    Product
    Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2006-2026·2026-05-06

    Leksell Vantage Arc System locking mechanism may not secure properly

    Elekta, Inc. is recalling the Leksell Vantage Arc System because locking mechanisms may fail to properly secure to the Arc system, which could cause coordinate shifting during medical procedures.

    Product
    Brand Name: Leksell Vantage Arc System REF: 1053958
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-2032-2026·2026-05-06

    Medline Neuro Sponges recalled for higher-than-expected endotoxin levels

    Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may exceed specifications.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2045-2026·2026-05-06

    Medline medical convenience kits recalled for non-sterile alcohol prep pads

    Medline Industries is recalling multiple medical convenience kits nationwide due to Webcol Large Alcohol Prep Pads that were found to be non-sterile. A contaminant (Paenibacillus phoenicis) was discovered during a routine sterilization dose audit.

    Product
    Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion); 2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A; 3. CVC DRESSING C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2026·2026-05-06

    Straumann n!ce PMMA Dental Implant Abutments Recalled for Screw Seat Defect

    Straumann USA LLC is recalling Straumann n!ce PMMA Full-arch Restoration screw-retained bridge abutments (Article 010.0304) due to an incorrect screw seat interface. Five units were distributed to dental offices in eight states.

    Product
    Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·H-0680-2026·2026-05-06

    [pending] Specially SELECTED brand Vanilla Creme Brulee; NET WT 3.6oz (103g); INGREDIENTS: CREAM (MILK, CREAM)

    Pending LLM rewrite. Source: FDA_FOOD H-0680-2026.

    Product
    Specially SELECTED brand Vanilla Creme Brulee; NET WT 3.6oz (103g); INGREDIENTS: CREAM (MILK, CREAM), FROZEN YOLK MIX (EGG YOLK, SUGAR) SUGAR, NATURAL VANILLA FLAVOR, TAPIOCA STARCH, CARRAGEENAN; TOPPING INGREDIENTS: CARAMEL FLAKES (SUGAR, GLUCOSE SYRUP); CONTAINS: MILK, EGGS. MA
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2036-2026·2026-05-06

    Medline medical procedure kits with neuro sponges recalled for endotoxin

    Medline Industries is recalling approximately 7004 medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that indicate out-of-specification product.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1951-2026·2026-05-06

    Philips Achieva 1.5T MRI Scanner Stiffness Calculation Error Recall

    Philips is recalling Achieva 1.5T MRI systems with MR Elastography software due to potential stiffness value errors that may occur with specific image reconstruction parameters, causing incorrect voxel size display in the default scan protocol.

    Product
    Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2039-2026·2026-05-06

    Medline Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads

    Medline Industries is recalling specific lots of medical convenience kits containing Webcol Large Alcohol Prep Pads because the pads were found to be non-sterile due to contamination with Paenibacillus phoenicis bacteria discovered during a sterilization audit.

    Product
    Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2026·2026-05-06

    Philips Evolution Upgrade 1.5T MRI Stiffness Calculation Error

    Philips North America is recalling Philips Evolution Upgrade 1.5T MRI systems with MR Elastography due to potential stiffness value errors that may result in incorrect voxel size settings in the default scan protocol.

    Product
    Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2010-2026·2026-05-06

    Medline Neuro Sponges in Medical Procedure Kits Recalled for High Endotoxin

    Medline Industries is recalling Medline medical procedure kits containing Neuro Sponges (EH BRONCHOSCOPY, Kit Number DYNJT3270) due to higher-than-expected endotoxin levels that may be out of specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT3270
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2019-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin

    Medline is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels found during an internal review, indicating in-market product may be out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. O
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2000-2026·2026-05-06

    i-STAT Blood Gas Analyzer Cartridges Recalled for Inaccurate Results

    Abbott is recalling certain i-STAT EG6+, EG7+, and G3+ blood gas cartridges that may report falsely high CO2 and falsely low pH results due to a manufacturing issue, potentially leading to unnecessary or harmful clinical interventions.

    Product
    i-STAT EG6+ cartridge; List Number: 03P77-25;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2035-2026·2026-05-06

    Medline robotic hysterectomy procedure kits recalled for elevated endotoxin

    Medline Industries is recalling robotic hysterectomy procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may indicate out-of-specification product in distribution worldwide.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C; 3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1990-2026·2026-05-06

    DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall

    DePuy Synthes is recalling 3 units of the ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM due to external sterile packaging found adhered to internal packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
    Category
    Medical Device
    Distribution
    Distributed nationwide