The Recall Desk

Archive

June 2025 recalls

524 recalls were announced in June 2025.

What the numbers show

Critical
6
Severe
230
High
195
Moderate
85
Low
8

Of the 524 recalls this month scored against our rubric, 1% are Critical, 44% are Severe.

101–200 of 524

  • SevereFDA (Devices)·Z-1934-2025·2025-06-18

    Philips Intera 1.5T MRI Systems Gradient Coil Fire Risk Recall

    Philips is recalling Intera 1.5T Omni/Stellar MRI systems due to a gradient coil component failure that can produce smoke and fire, risking patient and operator injury or death.

    Product
    Intera 1.5T Omni/Stellar; Product Number: 781104;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1953-2025·2025-06-18

    Tecfen Medical 20G MVR Sideport Knife ophthalmic sterility recall

    Tecfen Medical is recalling its 20G (1.2mm) MVR Sideport Knife Straight (Model QKN2312) ophthalmic knives due to sterility assurance concerns. The recall affects 38 units distributed in the US and internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1869-2025·2025-06-18

    Blood Products Administration Set Filter Mis-Assembly Recall

    Fresenius Kabi USA is recalling IVENIX INFUSION SYSTEM LVP Blood Products Administration Sets due to a mis-assembly error that may prevent the drip chamber filter from properly filtering large blood particulates.

    Product
    IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
    Category
    Medical Device
    Distribution
    18 states
  • SevereFDA (Food)·H-0033-2025·2025-06-18

    Jean's Classy Fresh Salsa Hot recalled due to Salmonella contamination

    TGD Cuts, LLC is recalling Jean's Classy Fresh Salsa, Hot (6/12 oz. plastic tubes) due to Salmonella contamination. The affected product was distributed to Maryland, Pennsylvania, North Carolina, Virginia, and New Jersey.

    Product
    Jean's Classy Fresh Salsa, Salsa, Hot 6/12 oz., Plastic tube, 6 per case .
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1952-2025·2025-06-18

    Tecfen Medical 2.8mm Slit Knife Angled Sterility Assurance Recall

    Tecfen Medical is recalling 2.8mm Slit Knife, Angled (Model QKN2808) ophthalmic surgical instruments due to sterility assurance concerns. Affected units were distributed in the US and internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V413000·2025-06-18

    Mazda CX-50 airbag module software may cause improper deployment

    Mazda is recalling certain CX-50 Hybrid and CX-50 vehicles because incorrectly configured module software may cause the airbag to deploy improperly. All affected vehicles are under dealer control.

    Product
    MAZDA — MAZDA CX-50 HYBRID, CX-50
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·25342·2025-06-18

    AstroAI 4-Liter/6-Can Minifridges Recalled Due to Fire and Burn Hazards

    AstroAI is recalling approximately 249,100 minifridges because the electrical switch can short circuit, causing fires and burn hazards. At least 70 incidents of smoking, burning, melting, or fire have been reported, including two fires that caused more than $360,000 in property damage.

    Product
    4 Liter/6 Can Minifridges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0021-2025·2025-06-18

    Sysco Created Fresh Tuna Salad Subs Recalled for Salmonella Risk

    Sysco Corporation is recalling Created Fresh Sub-Tuna Salad on Everything Ficelle (5.76 oz.) due to potential Salmonella contamination from cucumbers used in the product.

    Product
    HKSAN167 1/5.76 OZ. EA CREATED FRESH Sub- Tuna Salad on Everything Ficelle ALL LOT CODES HKSAN167 1/5.76 OZ. EA Created Fresh Sub- Tuna Salad on Everything Ficelle ALL LOT CODES
    Category
    Food
    Distribution
    18 states
  • SevereCPSC·25345·2025-06-18

    TADAKAZU Baby Loungers Recalled for Suffocation Fall and Entrapment Hazards

    TADAKAZU Baby Loungers violate federal infant sleep product standards, posing risks of suffocation, falls, and entrapment. The CPSC recommends immediate discontinuation and contact with TADAKAZU for refund.

    Product
    TADAKAZU Baby Loungers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0039-2025·2025-06-18

    Cucumber and Grape Tomato Product Recalled for Salmonella Contamination

    TGD Cuts, LLC is recalling Cucumber Sliced/Grape Tomato 50/2oz. packs due to Salmonella contamination. The affected product was distributed to Maryland, Pennsylvania, North Carolina, Virginia, and New Jersey.

    Product
    Cucumber Sliced/Grape Tomato 50/2oz. Pack, 50 per case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·H-0020-2025·2025-06-18

    Created Fresh Chicken Salad Sandwich Recalled for Salmonella Risk

    Sysco Corporation is recalling Created Fresh Chicken Salad on Everything Ficelle sandwiches due to potential Salmonella contamination from cucumbers used in the product.

    Product
    HKSAC168 6/5.76 OZ. CS CREATED FRESH Sub- Chicken Salad on Everything Ficelle- 6/6oz ALL LOT CODES HKSAN168 1/5.76OZ CREATED FRESH Sub- Chicken Salad on Everything Ficelle ALL LOT CODES HKSAC168 6/5.76 OZ. CS Created Fresh Sub- Chicken Salad on Everything Ficelle- 6/6oz ALL LOT C
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-1924-2025·2025-06-18

    Azure S DR MRI SureScan Pacemakers Recalled for Battery Failure Risk

    Medtronic Azure S DR MRI SureScan pacemakers may experience sudden battery power failure without warning, potentially interrupting therapy and leading to cardiac arrest or hospitalization. Affected devices are being recalled internationally.

    Product
    Azure S DR MRI SureScan, Product number W3DR01
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1866-2025·2025-06-18

    Z-800F Infusion System Recall Due to Unvalidated Software Versions

    Zyno Medical LLC is recalling the Z-800F Infusion System because unreleased software versions were installed on distributed devices without verification or validation. This poses a risk to patients receiving intravenous infusion therapy.

    Product
    Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0034-2025·2025-06-18

    Jean's Classy Fresh Salsa Mild recalled for Salmonella contamination

    TGD Cuts, LLC is recalling Jean's Classy Fresh Salsa, Mild (5 lbs.) due to Salmonella contamination. The product was distributed to Maryland, Pennsylvania, North Carolina, Virginia, and New Jersey.

    Product
    Jean's Classy Fresh Salsa, Salsa, Mild 5 lbs. 1 per case .
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0463-2025·2025-06-18

    Dietary Supplement Male Ultra Recalled for Undeclared Drug Ingredients

    Male Ultra dietary supplement, distributed nationwide in 3,000 boxes, has been recalled because laboratory testing found it contains undeclared pharmaceutical ingredients: propoxyphenylsildenafil and sildenafil. The product was marketed without FDA approval.

    Product
    Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0036-2025·2025-06-18

    Cucumber Sliced Unpeeled recalled for Salmonella contamination

    TGD Cuts, LLC is recalling Cucumber Sliced Unpeeled (5 lbs. per case, Item #6073) distributed to MD, PA, NC, VA, and NJ due to Salmonella contamination.

    Product
    Cucumber Sliced Unpeeled, Pack Size 5 lbs. , 1 per case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1931-2025·2025-06-18

    Philips Intera 1.5T Achieva Nova-Dual MRI System Fire Hazard Recall

    Philips is recalling three Intera 1.5T Achieva Nova-Dual MRI systems worldwide due to a gradient coil component failure that can generate smoke and fire, posing risks including burn injury and asphyxia.

    Product
    Intera 1.5T Achieva Nova-Dual Product Number: 781173;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0028-2025·2025-06-18

    Cucumber 5lb Cases Recalled Due to Potential Salmonella Contamination

    Lipman Family Farms is recalling Cucumber 5lb cases distributed across 18 states due to potential Salmonella contamination. Consumers should not consume the product and should dispose of it or return it to the retailer.

    Product
    Cucumber 5lb Repacked by Lipman Produce Hendersonville, NC 28792, Product of USA
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·H-0038-2025·2025-06-18

    Cucumber Sliced and Grape Tomato Packs Recalled for Salmonella Contamination

    TGD Cuts, LLC is recalling Cucumber Sliced/Grape Tomato 50/2oz. packs due to Salmonella contamination. The product was distributed to Maryland, Pennsylvania, North Carolina, Virginia, and New Jersey.

    Product
    Cucumber Sliced/Grape Tomato 50/2oz. Pack, 50 per case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1865-2025·2025-06-18

    Z-800 Infusion System recalled for unverified software installation

    Zyno Medical LLC is recalling 613 units of the Z-800 Infusion System distributed nationwide because unreleased software versions were installed on the devices without verification or validation.

    Product
    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0024-2025·2025-06-18

    East Coast Fresh Greek Pasta Salad Kit recalled for Salmonella risk

    Sysco Corporation is recalling East Coast Fresh Greek Pasta Salad Kits due to potential Salmonella contamination in cucumbers. No illnesses have been reported.

    Product
    KITGREEKPASTA5 1/5# EAST COAST FRESH PC-Greek Pasta Salad Kit 1/5lb W/Pasta ALL LOT CODES KITGREEKPASTA5 1/5# EAST COAST FRESH PC-Greek Pasta Salad Kit 1/5lb W/Pasta ALL LOT CODES KITGREEKPASTA51 1/5# EAST COAST FRESH Greek Pasta Salad Kit 1/5lb W/Pasta (RF) ALL LOT CODES
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·H-0035-2025·2025-06-18

    Jean's Classy Fresh Salsa Recalled Due to Salmonella Contamination

    Jean's Classy Fresh Salsa, Mild (5 lbs.) is being recalled due to Salmonella contamination. The product was distributed to Maryland, Pennsylvania, North Carolina, Virginia, and New Jersey.

    Product
    Jean's Classy Fresh Salsa, Salsa, Mild 5 lbs. 1 per case .
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·H-0029-2025·2025-06-18

    Lipman Family Farms Sliced Cucumbers Recalled for Potential Salmonella

    Lipman Family Farms is recalling sliced cucumbers due to potential Salmonella contamination. The product was distributed across multiple states, and consumers should not consume it.

    Product
    PR Cucumber Sliced 2/5# 1/4 Pack Date May 22 Product of USA Lipman Family Farms Hendersonville / NC
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·H-0023-2025·2025-06-18

    East Coast Fresh Salsa Products Recalled for Potential Salmonella Contamination

    Sysco Corporation is recalling multiple East Coast Fresh salsa products distributed across 18 states and Puerto Rico due to potential Salmonella contamination in cucumbers used in the product.

    Product
    RTSALSA1LB 1# EAST COAST FRESH Salsa Cup - 1 lb ALL LOT CODES SAL20 5# EAST COAST FRESH EC-Salsa- Fresh 5# ALL LOT CODES SAL210 6/1# EAST COAST FRESH Salsa- Fresh Retail 6x1# (E) ALL LOT CODES SAL45 20# EAST COAST FRESH EC-Salsa- Fresh 20# ALL LOT CODES SAL48 7# EAST COAST FRESH
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-1921-2025·2025-06-18

    SOLTIVE Premium SuperPulsed Laser System surgical instrument thermal incident

    Olympus is recalling the SOLTIVE Premium SuperPulsed Laser System due to risk of thermal incidents including smoke, sparks, burning, or flames during clinical use caused by fiber fracturing.

    Product
    Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0488-2025·2025-06-18

    Sulfamethoxazole and Trimethoprim Tablets Recalled for Microbial Contamination

    Amneal Pharmaceuticals is recalling Sulfamethoxazole and Trimethoprim Tablets (400 mg/80 mg) nationwide due to microbial contamination that may cause black spots on tablets. The contamination affects non-sterile products distributed across the USA.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1867-2025·2025-06-18

    Z-800W Infusion System Recalled for Unvalidated Software Installation

    Zyno Medical LLC is recalling the Z-800W Infusion System because unreleased software versions were installed on devices without verification or validation.

    Product
    Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0037-2025·2025-06-18

    Cucumber Sliced Unpeeled 2 oz. Pack Recalled for Salmonella

    TGD Cuts, LLC is recalling Cucumber Sliced Unpeeled (Item #7065, UPC #840219170657) in 2 oz. packs due to Salmonella contamination. The product was distributed to Maryland, Pennsylvania, North Carolina, Virginia, and New Jersey.

    Product
    Cucumber Sliced Unpeeled, Pack Size 50, 2 oz. , 50 per case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1963-2025·2025-06-18

    Microtek Patient Drape Adapter Plug Kits Recalled for Non-Sterile Labeling

    Microtek Medical is recalling Patient Drape adapter plug kits (models AP6MMN and AP8MMN) because non-sterile products were labeled as sterile. The affected adapters are used to connect drain hoses to fluid management devices.

    Product
    Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139429 These adapters function as accessories for a device or drape, serving to
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-1915-2025·2025-06-18

    Covidien Newport HT70 and HT70Plus Ventilators Capacitor Failure Recall

    Covidien is recalling Newport HT70 and HT70Plus ventilators due to capacitor failures that may cause the device to shut down unexpectedly or fail to alarm, risking respiratory failure and oxygen deprivation in patients.

    Product
    Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0464-2025·2025-06-18

    MALEXTRA Dietary Supplement Recalled for Undeclared Pharmaceutical Ingredients

    MALEXTRA Recharge with Extra dietary supplement is being recalled nationwide because laboratory testing found undeclared pharmaceutical ingredients propoxyphenylsildenafil and sildenafil in the product.

    Product
    MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1972-2025·2025-06-18

    BD Texium Closed System Drug Transfer Devices May Leak at Connector

    BD Texium closed system drug transfer devices in multiple sizes may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, exposure to hazardous drugs, and underdosing.

    Product
    BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0465-2025·2025-06-18

    Dietary Supplement Electro Buzz Recalled for Undeclared Active Pharmaceutical Ingredients

    SAINI TRADE INC is recalling ELECTRO BUZZ dietary supplement (lot KT-1ST-43-01-07/2024, expiring 10/15/2026) distributed nationwide. Laboratory testing found undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.

    Product
    ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0466-2025·2025-06-18

    Dietary Supplement ULTRA ARMOR Recalled for Undeclared Drug Ingredients

    ULTRA ARMOR dietary supplement, distributed by Health Fixer, is recalled nationwide because it contains undeclared pharmaceutical ingredients propoxyphenylsildenafil and sildenafil. The product was marketed without FDA approval.

    Product
    ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0467-2025·2025-06-18

    Male Ultra Pro dietary supplement recalled for undeclared pharmaceutical ingredients

    Male Ultra Pro capsules are being recalled because laboratory testing found undeclared propoxyphenylsildenafil and sildenafil. The product was marketed without an approved New Drug Application.

    Product
    Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1932-2025·2025-06-18

    Philips Intera 1.5T Explorer/Nova Dual MRI Gradient Coil Fire Risk

    Philips is recalling one Intera 1.5T Explorer/Nova Dual MRI system due to a gradient coil component that may overheat, produce smoke, or ignite, risking patient and operator injury.

    Product
    Intera 1.5T Explorer/Nova Dual Product Number: 781108;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0031-2025·2025-06-18

    Smartcuts Cucumber Sliced Trays recalled due to Salmonella contamination

    Smartcuts Cucumber Sliced Trays 2/2lb have been recalled because they may be contaminated with Salmonella. Affected lots include F13625, F13825, and F14025 with expiration dates from 05/25 to 05/29.

    Product
    Smartcuts Cucumber Sliced Trays 2/2lb
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·H-0097-2025·2025-06-18

    Non Fat Dry Milk Recalled for Potential Salmonella Contamination

    Crystal Creamery Inc. is recalling non fat dry milk due to potential Salmonella contamination. The affected product was distributed in California and Texas.

    Product
    NON FAT DRY MILK. "LOW HEAT SPRAY PROCESS GRADE A NON FAT DRY MILK MADE FROM PASTERUIZED MILK, NET WEIGHT 25.00 KG, PRODUCT OF U.S.A."
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1936-2025·2025-06-18

    Philips SmartPath to dStream 1.5T MRI Gradient Coil Fire Risk

    Philips SmartPath to dStream for 1.5T MRI systems are recalled due to potential gradient coil component failure that may produce smoke and fire, posing risks of inhalation injury, burns, asphyxia, and death.

    Product
    SmartPath to dStream for 1.5T¿; Product Number: 782146;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1969-2025·2025-06-18

    Azurion R1.x and R2.x X-ray systems software communication issue

    Philips Medical Systems has recalled Azurion R1.x and R2.x X-ray systems worldwide due to a software issue that can cause loss of imaging functionality and delay treatment, potentially resulting in serious harm or death in patients undergoing urgent or complex interventions.

    Product
    Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: Al
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1929-2025·2025-06-18

    Philips Intera 1.5T Achieva IT Nova MRI System Gradient Coil Fire Risk

    Philips is recalling one Intera 1.5T Achieva IT Nova MRI system due to a gradient coil component that may overheat and produce smoke or fire, posing risks of inhalation injury, burns, or death.

    Product
    Intera 1.5T Achieva IT Nova Product Number: 781175
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0026-2025·2025-06-18

    Cucumbers Recalled Due to Potential Salmonella Contamination

    Lipman Family Farms is recalling 24-count repacked cucumbers distributed across 18 states due to potential Salmonella contamination. Consumers should not consume the product and should discard or return affected cucumbers.

    Product
    Cucumber 24 Ct Repacked by Lipman Produce Hendersonville, NC 28792, Product of USA
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-1930-2025·2025-06-18

    Philips Intera 1.5T Achieva Nova MRI Systems Gradient Coil Fire Risk

    Philips is recalling certain Intera 1.5T Achieva Nova MRI systems due to a gradient coil component that can overheat, potentially causing smoke or fire with risk of burns, smoke inhalation, or asphyxia.

    Product
    Intera 1.5T Achieva Nova Product Number: 781172;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0030-2025·2025-06-18

    Cucumber Super Selec from Lipman Produce Recalled for Salmonella Risk

    Lipman Family Farms is recalling Cucumber Super Selec products due to potential Salmonella contamination. The affected cucumbers were distributed across multiple states.

    Product
    Cucumber Super Selec Repacked by Lipman Produce Hendersonville, NC 28792, Product of USA
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-1928-2025·2025-06-18

    Philips Achieva XR MRI systems recall for fire hazard

    Philips Achieva XR MRI systems may have a gradient coil component failure that can generate heat, smoke, and fire. The risk to patients and operators includes inhalation of smoke, burns, and asphyxia.

    Product
    Achieva XR Product Numbers: (1) 781153, (2) 781253;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0459-2025·2025-06-18

    Celecoxib Capsules 200 mg recalled for foreign tablets inside bottles

    Alembic Pharmaceuticals is recalling Celecoxib 200 mg capsules after a customer found a Tadalafil 5 mg tablet inside a sealed 500-count bottle. The contamination was discovered through a customer complaint.

    Product
    Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1868-2025·2025-06-18

    Z-800WF Infusion System software verification defect recall

    Zyno Medical LLC is recalling 613 units of the Z-800WF Infusion System because unreleased software versions were installed on distributed devices without verification or validation.

    Product
    Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2025·2025-06-18

    Tecfen Medical 3.2mm Slit Knife Angled Ophthalmic Knife Sterility Recall

    Tecfen Medical is recalling the 3.2mm Slit Knife, Angled model QKN3261 due to sterility assurance concerns. The recall affects units distributed nationwide in Connecticut and Minnesota as well as internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to crea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2025·2025-06-18

    Soltive Reusable Laser Fibers Recalled for Thermal Incident Risk

    Olympus Corporation of the Americas is recalling Soltive Reusable Laser Fibers due to risk of thermal incidents including smoke, sparks, burning, or unsteady flames during surgery, caused by fiber fracturing.

    Product
    Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150R-J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·25344·2025-06-18

    Crayan Mattresses Recalled for Fire Hazard Risk

    About 100,000 Crayan Mattresses fail to meet federal flame-resistance standards, posing a fire hazard. Consumers should stop using them immediately and contact Crayan for a refund.

    Product
    Crayan Mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1948-2025·2025-06-18

    Solana Bordetella Complete Assay Kit Recalled for False Positive Results

    Ortho-Clinical Diagnostics is recalling the Solana Bordetella Complete Assay Kit (Model M308) because it may produce false positive results for Bordetella parapertussis at a rate of up to 16.7%.

    Product
    Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1950-2025·2025-06-18

    Tecfen Medical 2.2mm Slit Knife ophthalmic device sterility recall

    Tecfen Medical is recalling its 2.2mm Slit Knife (Model QKN2261) due to sterility assurance concerns. The ophthalmic knife is used to create precise incisions for eye surgery.

    Product
    Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0019-2025·2025-06-18

    Sysco fresh salad products recalled for potential Salmonella contamination

    Sysco Corporation is recalling multiple fresh salad products because cucumbers used in the products have the potential to be contaminated with Salmonella. The recall affects salads sold under brands including East Coast Fresh and Created Fresh.

    Product
    5185 2/7.125# EAST COAST FRESH AUTHENTIC GREEK SALAD (4070 2/7.125# ALL LOT CODES HKSAL138 1/8 OZ. EA JACK AND OLIVE Salad- House- JO ALL LOT CODES HKSAL176 6/8 OZ. CS CREATED FRESH Salad- House- 6/8oz ALL LOT CODES HKSAL43 2/ 5 LB. CS CREATED FRESH Salad- Kit- Tomato Cucumber 2
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-1916-2025·2025-06-18

    Medical Device Convenience Kits Recalled for Ethylene Oxide Residual Contamination

    American Contract Systems, Inc. is recalling convenience kits containing cast padding due to elevated ethylene oxide and ethylene chlorohydrin residuals that may cause loss of functionality and delay treatment.

    Product
    LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1933-2025·2025-06-18

    Philips Intera 1.5T MRI Systems Gradient Coil Fire Risk Recall

    Philips is recalling two Intera 1.5T MRI systems due to a gradient coil component failure that can produce smoke or fire, posing risks of inhalation injury, burns, asphyxia, or death.

    Product
    Intera 1.5T Master/Nova Product Number: 781106;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2025·2025-06-18

    Femoral Nail RIGHT T2 GTN 8x300 mm labeled incorrectly

    Stryker GmbH is recalling Femoral Nail RIGHT T2 GTN 8x300 mm devices because some lots were labeled as left or right but contained the opposite orientation.

    Product
    Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V416000·2025-06-18

    REV Recalls 2025-2026 Fleetwood and Holiday Rambler Motorhomes for Electrical Defect

    REV is recalling 2025-2026 Fleetwood Altitude and Holiday Rambler Incline motorhomes because water intrusion may cause electrical components to fail, potentially disabling carbon monoxide or propane detectors.

    Product
    HOLIDAY RAMBLER — HOLIDAY RAMBLER, FLEETWOOD INCLINE, ALTITUDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V410000·2025-06-18

    2026 Tesla Model Y and Model 3 Vehicles Seat Fastener Recall

    Tesla is recalling certain 2026 Model Y and Model 3 vehicles because seat back fasteners may have been improperly tightened, potentially affecting proper occupant restraint during a crash.

    Product
    TESLA — TESLA MODEL 3, MODEL Y
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25341·2025-06-18

    YaFiti White 12-Drawer Dressers Recalled for Tip-Over Entrapment Hazards

    YaFiti 12-Drawer White Dressers pose serious tip-over and entrapment hazards to children if not anchored to the wall, violating federal standards. About 6,000 units sold on Amazon from September 2023 through March 2025.

    Product
    YaFiti 12-Drawer White Dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25C008000·2025-06-18

    Evenflo Recalls Titan 65 Child Seats Due to Incorrect Instruction Manuals

    Evenflo is recalling Titan 65 child seats manufactured in early 2025 that may have incorrect instruction manuals, posing a risk of improper installation.

    Product
    EQUIPMENT:OTHER:OWNERS/SERVICE/OTHER MANUAL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0017-2025·2025-06-18

    Rocky Road Ice Cream 1.5 qt with Mislabeled Tree Nut Allergen

    Unilever Manufacturing is recalling Rocky Road Ice Cream due to conflicting allergen labeling—the tub says "may contain tree nuts" while the lid declares almonds are present. Consumers with tree nut allergies may be at risk.

    Product
    Rocky Road Ice Cream packaged in a Breyer Chocolate Truffle Tub that says "may contain tree nuts" with a Breyers Rocky Road Ice Cream Lid that declares almonds as an ingredient. 1.5 qt
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·25V418000·2025-06-18

    Mazda Recalls 2025 CX-50 Hybrid for Gear Shifter Safety Issue

    Mazda is recalling 2025 CX-50 Hybrid vehicles because the gear shifter can move to Drive without pressing the brake pedal, increasing crash risk.

    Product
    MAZDA — MAZDA CX-50 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25343·2025-06-18

    Polaris Ranger XP and Pro XD Kinetic ROVs Recalled for Fire Hazard

    Polaris is recalling Model Year 2023-2024 Ranger XP Kinetic and Model Year 2025 Pro XD Kinetic ROVs because water can leak through a cracked filter into the high-voltage charging harness and cause a fire. The company has received 47 reports of filter failures, including six reports of melting or fire.

    Product
    Model Year 2023-2024 Ranger XP Kinetic and Model Year 2025 Pro XD Kinetic ROVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2025·2025-06-18

    BD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk

    BD TEXIUM closed male luer drug transfer devices may leak at the interface between the closed male luer component and the needle-free connector, potentially causing procedure delays, treatment interruptions, hazardous drug exposure, and medication underdosing.

    Product
    BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2025·2025-06-18

    BD Texium Needle-Free Syringe Recalled for Potential Leakage at Luer Interface

    BD Texium Needle-Free Syringes (multiple sizes) may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, medication underdosing, or exposure to hazardous drugs.

    Product
    BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2025·2025-06-18

    EPIONE Stereotactic Device Software Bug Poses Instrument Guidance Risk

    The EPIONE Model 30-0001 stereotactic device is recalled due to a software bug that may cause the robotic arm to incorrectly guide surgical instruments during CT-guided ablation procedures. Four units have been distributed in the U.S.

    Product
    EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0044-2025·2025-06-18

    Post Honey Bunches of Oats with Almonds Cereal Recall

    Post Consumer Brands is recalling Post Honey Bunches of Oats with Almonds cereal (48 oz boxes) due to the presence of metal fragments. Consumers who have purchased affected products should not consume them.

    Product
    Post Honey Bunches of Oats with Almonds. Sweetened Cereal with Oats and Honey. Net Wt 48 oz (3 lbs) 1.36kg. 2 Bags inside for freshness. UPC 8 84912-01428 3. Post Consumer Brands, LLC, Lakeville, MN 55044.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1925-2025·2025-06-18

    Digital Acquisition Box Electrode Placement Labels Applied Backwards

    Natus Neurology has recalled the OBM00002 OBM DAB (Digital Acquisition Box) because electrode placement labels were applied backwards. This may lead to misdiagnosis of seizure location in neonates monitored with the device.

    Product
    Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0929-2025·2025-06-18

    Gluten Free Vegan Peanut Butter Jam Cookie recalled for undeclared sesame

    Sweetheart USA, LLC is recalling Gluten Free Vegan Peanut Butter Jam Cookies because the product contains undeclared sesame, a common allergen. The recall affects 53 units distributed to 11 restaurants in Ohio.

    Product
    Gluten Free Vegan Peanut Butter Jam Cookie, Net Wt. 3.5 oz (200g), packaged individually in plastic
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0018-2025·2025-06-18

    Sysco Corporation Cucumbers Recalled for Potential Salmonella Contamination

    Sysco Corporation is recalling cucumber products sold under the Imperial Fresh, East Coast Fresh, Just Cut, Wellsley Farms, and other brands due to potential Salmonella contamination. The products were distributed to multiple states and Puerto Rico.

    Product
    3909520 2/5# IMPERIAL FRESH CUCUMBER DICED 3/8 SK-ON ALL LOT CODES 480414 2/5 # IMPERIAL FRESH FC CUCUMBER STRIPED AND SLICED ALL LOT CODES 481768 12/3 OZ IMPERIAL FRESH FC VEG VEGGIE W/HUMMUS SMALL P ALL LOT CODES 511666 2/5 # IMPERIAL FRESH FC CUCUMBER SLICED SKIN ON ALL LOT CO
    Category
    Food
    Distribution
    18 states
  • HighFDA (Food)·F-0931-2025·2025-06-18

    Instant Milk Tea Honeydew Flavor powder lacks milk allergen declaration

    R&M Refresher Instant Milk Tea Honeydew Flavor powder contains milk ingredients (whey powder and sodium caseinate) but does not declare milk on the label, posing an allergen risk to consumers with milk allergies.

    Product
    Instant Milk Tea Honeydew Flavor, R&M Refresher brand, B0D7269JC1, net wt. 1lb. Product was sold in 1-pack or 3-pack. Parent ASIN #B0D728CZWS 1-pack ASIN #B0D7269JC1 3-pack ASIN #B0D726K269 Label declares Ingredients: Non-Dairy Creamer (Glucose Syrup, Vegetable Oil, Whey Powd
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0937-2025·2025-06-18

    Taylor Shellfish Farms Geoduck Chowder Base Recall for Undeclared Anchovies

    Vern's Foods & Farm is recalling Taylor Shellfish Farms Geoduck Chowder Base because the product contains anchovies that are not declared on the label, creating a risk for people with fish allergies.

    Product
    Taylor Shellfish Farms Geoduck Chowder Base, frozen, Ingredients: Potatoes, Clam (Geoduck) ***Butter (Cream, Salt), Fish Sauce Ka Me***CONTAINS: MILK, CLAMS. Product is packed in rigid plastic tubs. Net wt. 16 oz. Produced with local, farm fresh ingredients by: Vern's Foods &
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0460-2025·2025-06-18

    Celecoxib Capsules Recalled for Foreign Tablet Contamination

    AvKARE is recalling Celecoxib 200 mg capsules because one tadalafil 5 mg tablet was found in a 500-count bottle. The contamination poses a risk of unintended drug exposure to patients.

    Product
    CELECOXIB — CELECOXIB (CELECOXIB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0049-2025·2025-06-18

    Creamy Butter Sauce recalled for wood-like pieces in ingredient

    GoodSource Solutions is recalling Creamy Butter Sauce (Lot 701493) because the product was manufactured with recalled cilantro containing small wood-like pieces.

    Product
    Sauce, Creamy Butter; packaged in clear, unlabeled bulk 6-pound bags/4 bags to a case. Lot code# 701493 stamped on bag.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1918-2025·2025-06-18

    Kendall SCD Comfort Sleeves Pediatric Knee Length Software Error Recall

    Kendall SCD Comfort Sleeves Knee Length Small Pediatric models may experience frequent E1 errors due to incorrect software logic, potentially delaying treatment or therapy.

    Product
    Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1919-2025·2025-06-18

    Kendall SCD Blended Comfort Sleeves Recalled for Software Logic Error

    Cardinal Health is recalling Kendall SCD Blended Comfort Sleeves (Knee Length Small, SKU 84021B) due to incorrect software logic that may cause frequent E1 errors. The issue may delay treatment or therapy.

    Product
    Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1956-2025·2025-06-18

    Contact Lens Insertion Solution Recalled for Potential Sterility Defect

    Contamac Nutrifill Physiologic formula contact lens insertion solution is being recalled because it may lack sterility. The affected product was distributed nationwide.

    Product
    Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2025·2025-06-18

    Stryker Gamma4 Long Nail with incorrect left-nail geometry recalled

    Stryker GmbH is recalling a specific lot of Gamma4 Right Long Nails (Catalog Number 84250320S) because they were manufactured with left-nail geometry instead of right-nail geometry, which could affect surgical fit and function.

    Product
    Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0043-2025·2025-06-18

    Atlantic Salmon Portions with Seafood Stuffing Recalled for Undeclared Soy Allergen

    Santa Monica Seafood Company is recalling Atlantic Salmon Portions with Seafood Stuffing due to incorrect labeling that fails to declare soy as an allergen ingredient.

    Product
    Atlantic Salmon Portions with Seafood Stuffing; 16 OZ (1 LB) 454g; Use/Freeze By: JUN.02.25; UPC: 4061459716313
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1917-2025·2025-06-18

    SCD Comfort Knee Length sleeves recalled for software logic errors

    Cardinal Health is recalling SCD Comfort Knee Length Small sleeves (SKU 84021) due to incorrect software logic that may cause frequent E1 errors and delay patient treatment.

    Product
    SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1975-2025·2025-06-18

    SmartRelease Onyx Blade Assembly Surgical System Recalled

    MicroAire Surgical Instruments is recalling the SmartRelease ESTR Onyx Blade Assembly due to a potential risk that the blade can unintentionally cut tissue before the user deploys it.

    Product
    Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1962-2025·2025-06-18

    Baxter Healthcare 2.5V Rechargeable Batteries for PocketScope Handles

    Baxter Healthcare is recalling 2.5V rechargeable batteries for Welch Allyn PocketScope handles due to potential short circuits that can cause excessive heat and user burns.

    Product
    2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2025·2025-06-18

    Tecfen Medical 2.4mm Slit Knife Angled Ophthalmic Knife Recall

    Tecfen Medical is recalling its 2.4mm Slit Knife, Angled (Model QKN2461) due to sterility assurance concerns. The ophthalmic knife is used to create precise incisions for controlled entry into the eye.

    Product
    Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1820-2025·2025-06-18

    OEC Elite and OEC 3D Mobile C-Arms X-ray Field Size Defect

    GE Medical Systems is recalling certain OEC Elite and OEC 3D mobile C-arm imaging systems because some units may produce X-ray fields that exceed acceptable limits, posing a potential radiation safety risk.

    Product
    OEC 3D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1938-2025·2025-06-18

    MUSE 5 Cardiovascular Systems Recall Administrator Credential Access

    GE Medical Systems is recalling MUSE 5 Systems due to a vulnerability that could allow unauthorized access to patient data. The MUSE Administrator Account credentials could potentially be used to log into affected systems from the local network and manipulate recorded cardiovascular patient data.

    Product
    MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1957-2025·2025-06-18

    KWIK-STICK Quality Control Kit for Culture Media Swab Mix-Up

    Microbiologics Inc is recalling KWIK-STICK quality control kits because products were packaged with incorrect microorganism swabs, which may lead to delayed diagnosis of patient samples in clinical laboratories.

    Product
    KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1949-2025·2025-06-18

    Tecfen Medical 15 degree Stab Knife sterility assurance recall

    Tecfen Medical is recalling its 15 degree Stab Knife (Model QKN1501) due to sterility assurance concerns. The ophthalmic knife is used in eye surgeries and was distributed in the US and internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Stab knives ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2025·2025-06-18

    Allon 2001 Medical Device Heating System Malfunction Risk

    Belmont Instrument's Allon 2001 device may heat water above safe limits if sensor connections fail and temperature alarms are disabled. The patient wrap may exceed its set temperature without user notification.

    Product
    Allon 2001. Part Number: 200-00263
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2025·2025-06-18

    iBOT PMD Personal Mobility Device Software Update Recall

    Mobius Mobility LLC is recalling 442 units of the iBOT PMD (Personal Mobility Device) with software version 01.05.24 due to a software issue that could cause the device to tip over during Balance Mode operation.

    Product
    iBOT PMD with software version 01.05.24. Personal Mobility Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0040-2025·2025-06-18

    Tortilla Products Recalled for Undeclared Soy Allergen

    Tortilleria Xpress Inc is recalling multiple tortilla products due to undeclared soy allergen. Consumers with soy allergies who purchased these products should not consume them.

    Product
    Tortilla de mesa with 12 units per package, Tortilla Pirata with 10 units per package, Tortilla cruda especial with 20 units per package, Tortilla Cruda Pirata with 20 units per package
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1973-2025·2025-06-18

    BD TEXIUM Closed Male Luer Drug Transfer Device Recall

    BD TEXIUM Closed Male Luer devices may leak at the interface between the closed male luer component and needle-free connector. The leak could cause procedure delays, treatment interruptions, exposure to hazardous drugs, and underdosing of medication.

    Product
    BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1939-2025·2025-06-18

    Femoral Nail T2 GTN Left and Right Versions Mislabeled

    Stryker GmbH is recalling certain Femoral Nail T2 GTN devices because some labeled as left version contained right nails, and vice versa. This mislabeling could result in incorrect surgical implantation.

    Product
    Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2025·2025-06-18

    Tecfen Medical 2.0mm Crescent Knife Ophthalmic Device Recall

    Tecfen Medical is recalling 2.0mm Crescent Knife ophthalmic surgical instruments (Model QKN1010, Lot ZGY24071501-03) due to sterility assurance concerns. The affected devices were distributed in the US and internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent kn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1970-2025·2025-06-18

    Alaris Pump Infusion Sets may leak at male luer connections

    BD Switzerland is recalling multiple Alaris Pump Infusion Set models worldwide due to potential leaks at the connection between the closed male luer component and needle-free connector, which could delay procedures, interrupt treatment, expose patients to hazardous drugs, or result in underdosing.

    Product
    Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0935-2025·2025-06-18

    Instant Milk Tea Brown Sugar Powder recalled for undeclared milk allergen

    R&M Refresher brand Instant Milk Tea Brown Sugar Flavor is recalled because the ingredients contain milk (Whey Powder, Sodium Caseinate) but the label does not declare milk as an allergen.

    Product
    Instant Milk Tea Brown Sugar Flavor, R&M Refresher brand, B0D725TXQW, net wt. 1lb. Product is sold in 3-pack. Parent ASIN #B0D728CZWS 3-pack ASIN #B0D72FQVDR Ingredients: Non-Dairy Creamer (Glucose Syrup, Vegetable Oil, Whey Powder, Sodium Caseinate***). Product of China. Dis
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2025·2025-06-18

    OEC Elite and OEC 3D Mobile C-Arms X-ray Field Size Exceeds Limit

    GE Medical Systems is recalling certain OEC Elite and OEC 3D mobile C-arm systems that may produce X-ray fields exceeding acceptable limits. Some units also lack proper acceptance limits in their service manuals.

    Product
    OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1920-2025·2025-06-18

    SOLTIVE Pro SuperPulsed Laser System surgical instrument thermal incident

    Olympus Corporation of the Americas is recalling the SOLTIVE Pro SuperPulsed Laser System due to risk of unexpected smoke, sparks, burning, or unsteady flames caused by fiber fracturing during clinical use.

    Product
    Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0934-2025·2025-06-18

    Instant Milk Tea Powder lacks milk allergen declaration

    R&M Trading LLC is recalling Instant Milk Tea Original Flavor because the label does not declare milk, despite containing whey powder and sodium caseinate, which are milk-derived ingredients.

    Product
    Instant Milk Tea Original Flavor, R&M Refresher brand, B0D71YHZX4, net wt. 1lb. Product is sold in 1-pack or 3-pack. Parent ASIN #B0D728CZWS 1-pack ASIN #B0D71YHZX4 3-pack ASIN #B0D72BLQRW Label declares Ingredients: Non-Dairy Creamer (Glucose Syrup, Vegetable Oil, Whey Powder
    Category
    Food
    Distribution
    Distributed nationwide

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