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 →

401–425 of 26383

  • HighFDA (Devices)·Z-2028-2026·2026-05-06

    Centurion Surgical ENT Prep Kits with Medline Neuro Sponges Recalled

    Medline Industries is recalling Centurion Surgical ENT Prep Kits (Medline Neuro Sponges) due to higher-than-expected endotoxin levels that may render the product out-of-specification. Approximately 3,000 kits have been distributed worldwide.

    Product
    Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2001-2026·2026-05-06

    Abbott i-STAT Blood Gas Cartridges Reporting Inaccurate pH and PCO2 Results

    Abbott Point Of Care Inc. is recalling approximately 7.6% of i-STAT G3+, i-STAT EG6+, and i-STAT EG7+ blood gas cartridges due to a manufacturing issue causing falsely high PCO2 and low pH readings, which may lead to unnecessary or harmful clinical interventions.

    Product
    i-STAT G3+ cartridge; List Number: 03P78-26;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2026-2026·2026-05-06

    Medline Medical Procedure Kits Recalled for Higher Endotoxin Levels

    Medline Industries is recalling medical procedure kits containing neuro sponges worldwide because testing found higher-than-expected endotoxin levels, indicating products may be out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L; 2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J; 3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I; 4. PK-MAD,SPI
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2005-2026·2026-05-06

    epoc BGEM BUN Test Card for epoc Blood Analysis System

    Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards due to risk of inaccurate pH and carbon dioxide readings that could lead to inappropriate or missed treatment of acid-base disorders.

    Product
    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2026·2026-05-06

    Medline IV Start and Securement Kits Recalled for Non-Sterile Alcohol Prep Pads

    Medline Industries is recalling multiple IV start and securement kits nationwide because they contain non-sterile Webcol Large Alcohol Prep Pads due to discovery of a bacterial contaminant during sterilization testing.

    Product
    Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 2. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 3. IV START KIT (Centurion), Medline Kit SKU IV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2026·2026-05-06

    Medline Microdisectomy Kits Recalled for High Endotoxin Levels

    Medline is recalling Microdisectomy Packs containing Neuro Sponges due to higher-than-expected endotoxin levels found during an internal review. The affected products may be out-of-specification for endotoxin.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1999-2026·2026-05-06

    Abbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results

    Abbott Point Of Care is recalling approximately 7.6% of specific i-STAT EG7+ cartridge lots due to a manufacturing issue causing falsely high pCO2 and low pH readings. Inaccurate results could lead clinicians to make unnecessary or harmful medical interventions.

    Product
    i-STAT EG7+ cartridge; List Number: 03P76-25;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2042-2026·2026-05-06

    Medline Centurion Medical Convenience Kits Recalled for Non-Sterility

    Medline Industries is recalling Centurion medical convenience kits containing Webcol Large Alcohol Prep Pads due to discovery of non-sterile product contaminated with Paenibacillus phoenicis bacteria during sterilization testing.

    Product
    Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE TRAY, Medline Kit SKU 75670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2013-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled

    Medline Industries 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, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479; 2. CRANIO/NEURO/SPINE, Medline kit number/SKU DYNJ901072D.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1987-2026·2026-05-06

    DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall

    DePuy Synthes is recalling one lot of ATTUNE Revision Hinge Femoral components (left size 7, part number 150450107) due to external sterile packaging adhered to internal packaging, potentially compromising product sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2033-2026·2026-05-06

    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 found on the products. Affected kits were distributed worldwide.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0677-2026·2026-05-06

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

    Pending LLM rewrite. Source: FDA_FOOD H-0677-2026.

    Product
    52USA brand POPPING BOBA; PASSION FRUIT 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
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2011-2026·2026-05-06

    Medline medical procedure kits recalled for out-of-specification endotoxin levels

    Medline Industries is recalling medical procedure kits containing Neuro Sponges for spinal fusion 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: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG
    Category
    Medical Device
    Distribution
    0 states
  • 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-2023-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin

    Medline Industries is recalling three medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels identified during internal review. The affected kits may be out-of-specification for endotoxin.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ90836
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2038-2026·2026-05-06

    Medline Medical Procedure Kits Recalled for High Endotoxin Levels

    Medline is recalling certain medical procedure kits containing neuro sponges because they may have higher-than-expected endotoxin levels, indicating out-of-specification product in the market.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
    Category
    Medical Device
    Distribution
    0 states
  • 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-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