The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

Filters

Agency

Category

Minimum severity

876–900 of 30631

  • HighFDA (Devices)·Z-1943-2026·2026-05-06

    Mesh Style Tip Protectors recalled lacking FDA clearance

    Healthmark Industries Co., Inc. is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) distributed nationwide because the product does not have FDA clearance.

    Product
    Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2018-2026·2026-05-06

    Medline medical procedure kits recalled for elevated endotoxin levels

    Medline Industries is recalling 208 medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may exceed product specifications.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2017-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin

    Medline Industries is recalling multiple medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels. The affected kits were distributed worldwide.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number/SKU CDS840193V; 2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J; 3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G; 4. PICC LINE PACK
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1989-2026·2026-05-06

    DePuy Synthes ATTUNE Revision Hinge Femoral Component Recall

    DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT Size 3 Cement components due to external sterile packaging that was adhered to internal sterile packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2026·2026-05-06

    WHILL Model C2 Powered Wheelchair Recalled for Bluetooth Security Vulnerability

    WHILL Model C2 powered wheelchairs with software versions before HMI 2.22 and MC 1.13 are recalled due to a Bluetooth Low Energy (BLE) communication vulnerability identified by CISA. Approximately 4,685 units distributed in Kansas are affected.

    Product
    WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1992-2026·2026-05-06

    Depuy Synthes ATTUNE Revision Hinge Femoral implants recalled for sterility risk

    DePuy Synthes is recalling ATTUNE Revision Hinge Femoral knee implants because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2026·2026-05-06

    Medline Medical Kits Recalled for Non-Sterile Alcohol Prep Pads

    Medline Industries is recalling specific blood culture and blood draw kits containing Webcol Large Alcohol Prep Pads that were found to be non-sterile due to bacterial contamination discovered during a sterilization audit.

    Product
    Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520; 2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2012-2026·2026-05-06

    Medline Neuro Sponges in Spine Procedure Kits Recalled for Out-of-Specification Endotoxin

    Medline is recalling Spine Pack-LF medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels detected during an internal review. The affected kits were distributed worldwide.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0678-2026·2026-05-06

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

    Pending LLM rewrite. Source: FDA_FOOD H-0678-2026.

    Product
    52USA brand POPPING BOBA; MANGO 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), carrageenan (EE407), potas
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2024-2026·2026-05-06

    Medline Medical Procedure Kits Recalled for High Endotoxin Levels

    Medline Industries is recalling medical procedure kits containing Neuro Sponges because of higher-than-expected endotoxin levels that may render the product out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B; 3. ENT PK 1008847, Medline Kit Number/SKU DYNJ42319C; 4. ENDO SINUS PACK, Medl
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2025-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin

    Medline is recalling 22,116 medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may be out-of-specification. The products are distributed worldwide.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)
    Category
    Medical Device
    Distribution
    0 states
  • 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