The Recall Desk

Archive

October 2025 recalls

804 recalls were announced in October 2025.

What the numbers show

Critical
179
Severe
78
High
390
Moderate
154
Low
3

Of the 804 recalls this month scored against our rubric, 22% are Critical, 10% are Severe.

601–700 of 804

  • SevereCPSC·26008·2025-10-09

    Portable waist fans recalled after four reports of melting or fire

    About 48,000 Living Glow five-in-one portable waist fans are being recalled because the lithium-ion batteries can overheat while charging; four fans have melted or caught fire.

    Product
    Living Glow portable waist fan
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V677000·2025-10-09

    Braun Ambulances Recall 2023-2026 Models Due to Cruise Control Defect

    Braun Industries is recalling 2023-2026 ambulances because a damaged brake pedal switch may prevent cruise control from disengaging, increasing crash risk.

    Product
    BRAUN AMBULANCES — BRAUN AMBULANCES LIBERTY TYPE I, EXPRESS PLUS TYPE I, CHIEF XL TYPE I, SELECT CHIEF XL I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V676000·2025-10-09

    Nissan and Chevrolet Vans Recalled for Fuel Pump Fuse Short Circuit Risk

    Nissan is recalling 2013-2021 NV200 and 2015-2018 Chevrolet City Express vans because a misrouted sensor harness may damage wires, causing a short circuit that could stall the engine.

    Product
    NISSAN — NISSAN, CHEVROLET NV200, NV200 TAXI, CITY EXPRESS, CHEVEROLET SS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V680000·2025-10-09

    Genesis Supreme Recalls One Fifth Wheel Trailer Due to Fire Risk

    Genesis Supreme RV is recalling one 2024 Supreme 28IKS fifth wheel trailer because the air conditioner soft start device may overheat and cause a fire.

    Product
    GENESIS SUPREME — GENESIS SUPREME FIFTH WHEEL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2662-2025·2025-10-08

    MAGNETOM Skyra Fit BioMatrix systems recalled over magnet vent ice blockage

    Siemens is recalling 39 MAGNETOM Skyra Fit BioMatrix systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2659-2025·2025-10-08

    MAGNETOM Prisma MRI systems recalled over helium venting ice blockage

    Siemens is recalling 101 MAGNETOM Prisma MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Prisma. Model Number: 10849582.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2617-2025·2025-10-08

    Atlan A350XL anesthesia workstations recalled after piston ventilator failures during use

    Draeger is recalling 223 Atlan A350XL anesthesia workstations that either indicated a piston ventilator failure before use or suffered a mechanical ventilation failure during use.

    Product
    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ve
    Category
    Medical Device
    Distribution
    25 states
  • CriticalFDA (Devices)·Z-2668-2025·2025-10-08

    MAGNETOM Vida Fit MRI systems recalled over magnet vent ice blockage

    Siemens is recalling 41 MAGNETOM Vida Fit MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Vida Fit. Model Number: 11410481.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2664-2025·2025-10-08

    MAGNETOM Verio MRI systems recalled over magnet venting ice blockage risk

    Siemens is recalling 154 MAGNETOM Verio MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Verio. Model Number: 10276755.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2667-2025·2025-10-08

    MAGNETOM Vida MRI systems recalled over ice blockage in magnet venting

    Siemens is recalling 498 MAGNETOM Vida (DE) MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2658-2025·2025-10-08

    MAGNETOM Lumina MRI systems recalled over helium venting ice blockage risk

    Siemens is recalling 130 MAGNETOM Lumina (DE) MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Lumina (DE). Model Number: 11344916.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2660-2025·2025-10-08

    MAGNETOM Skyra MRI systems recalled over ice blockage in venting system

    Siemens is recalling 586 MAGNETOM Skyra (DE) MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2663-2025·2025-10-08

    MAGNETOM Spectra MRI systems recalled over helium venting ice blockage

    Siemens is recalling three MAGNETOM Spectra MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2612-2025·2025-10-08

    Reprocessed electrophysiology catheters recalled over residual particulates on patient surfaces

    Medline is recalling 7,913 reprocessed Inquiry Steerable Diagnostic Catheters because specific lots may carry small residual particulates on patient-contacting surfaces.

    Product
    Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 81104RH 81107RH 81174RH 81402RH 81404RH 81405RH 81472RH 81473RH 81474RH 81531RH 81532RH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2666-2025·2025-10-08

    MAGNETOM Verio Dot Upgrade systems recalled over magnet venting ice blockage

    Siemens is recalling 78 MAGNETOM Verio Dot Upgrade systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2655-2025·2025-10-08

    BIOGRAPH One scanner recalled over ice blockage in magnet venting system

    Siemens is recalling one BIOGRAPH One (DE) system because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    BIOGRAPH One (DE). Model Number: 11689172.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2656-2025·2025-10-08

    MAGNETOM Cima.X systems recalled over ice blockage in helium venting system

    Siemens is recalling 22 MAGNETOM Cima.X (DE) systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Cima.X (DE). Model Number: 11647158.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2611-2025·2025-10-08

    Reprocessed cardiac mapping catheters recalled over residual particulates on device surfaces

    Medline is recalling 7,913 reprocessed Webster CS 10-electrode catheters because specific lots may carry small residual particulates on patient-contacting surfaces.

    Product
    Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2654-2025·2025-10-08

    Biograph mMR scanners recalled over ice blockage in magnet venting

    Siemens is recalling 27 Biograph mMR systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    Biograph mMR. Model Number: 10433372.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2613-2025·2025-10-08

    Reprocessed cardiac imaging catheters recalled over residual particulates on device surfaces

    Medline is recalling 7,913 reprocessed ViewFlex Xtra ICE catheters because specific lots may carry small residual particulates on patient-contacting surfaces.

    Product
    Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2661-2025·2025-10-08

    MAGNETOM Skyra fit MRI systems recalled over magnet vent ice blockage

    Siemens is recalling 56 MAGNETOM Skyra fit MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Skyra fit. Model Number: 10849580.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2610-2025·2025-10-08

    Reprocessed steerable electrophysiology catheters recalled over residual particulates on surfaces

    Medline is recalling 7,913 reprocessed Livewire Steerable Electrophysiology Catheters because specific lots may carry small residual particulates on patient-contacting surfaces.

    Product
    Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH 401915RH 401918RH 401932RH 401933RH 401934RH 401938RH 401939RH 401940RH 401941
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2592-2025·2025-10-08

    Surgical convenience kits recalled after being labeled sterile without sterilization process

    Medline is recalling 22 Major Pack L-F and LB Basic Custom Pack convenience kits that were labeled as sterile but never went through the sterilization process.

    Product
    Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
    Category
    Medical Device
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-2614-2025·2025-10-08

    Reprocessed ultrasound catheters recalled over residual particulates on patient contacting surfaces

    Medline is recalling 7,913 reprocessed ACUSON AcuNav ultrasound catheters because specific lots may carry small residual particulates on patient-contacting surfaces.

    Product
    Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac interventio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2665-2025·2025-10-08

    MAGNETOM Verio Dot systems recalled over magnet venting ice blockage risk

    Siemens is recalling 59 MAGNETOM Verio Dot systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Verio Dot. Model Number: 10684333.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2616-2025·2025-10-08

    Atlan A350 anesthesia workstations recalled after mechanical ventilation failures were reported

    Draeger is recalling 530 Atlan A350 anesthesia workstations that either indicated a piston ventilator failure before use or suffered a mechanical ventilation failure during use.

    Product
    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical vent
    Category
    Medical Device
    Distribution
    25 states
  • CriticalFDA (Devices)·Z-2657-2025·2025-10-08

    MRI scanner recalled over ice blockage in magnet helium venting system

    A MAGNETOM Connectom.X MRI system is being recalled because an ice blockage in the magnet venting system could prevent helium from escaping during a quench.

    Product
    MAGNETOM Connectom.X. Model Number: 11371480.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2670-2025·2025-10-08

    Surgical valve pack kits recalled after cannulas may not retain shape

    Medline is recalling 828 VALVE PACK-LF kits because they contain lots of cannula products where the catheter may not retain its shape.

    Product
    Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0647-2025·2025-10-08

    Sheep milk tomme cheese recalled after Listeria found in production batch

    Goot Essa is recalling 62 lbs of Der Mutterschaf sheep tomme style cheese after a sample from the batch tested positive for Listeria monocytogenes.

    Product
    Goot Essa, Der Mutterschaf Cheese, Sheep Tomme Style. 4 and 8 OZ. ( Pasteurized Sheep Milk, Salt, Vegetable Enzymes, Cheese Cultures ).
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·H-0002-2026·2025-10-08

    Granola recalled after incorrect label omitted wheat, sesame and cashew allergens

    Whole Foods Market is recalling six one-pound containers of Blueberry Almond Granola sold at a single Philadelphia store because a labeling error left wheat, sesame and cashew undeclared.

    Product
    Whole Foods Market Blueberry Almond Granola, PLU 86032, packaged in a clear plastic container.
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·25V672000·2025-10-08

    BMW motorcycles recalled over cardan shaft that may lose drive power

    BMW is recalling three 2026 R 1300 RT motorcycles whose cardan shaft may not have been sufficiently hardened, allowing the universal joint to slip and causing a loss of drive power.

    Product
    BMW — BMW R 1300 RT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V671000·2025-10-08

    2026 BMW X6 and X4 Vehicles Recalled for Windshield Seal Defect

    BMW is recalling 2026 X6 and X4 vehicles because the windshield may not be sealed properly, allowing water to enter electrical components and potentially causing loss of lights, door functions, or fire.

    Product
    BMW — BMW X4, X6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2026·2025-10-08

    Reprocessed 1.4mm rapid exchange atherectomy catheters recalled for packaging breaches

    Northeast Scientific is recalling 1,019 reprocessed 1.4mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0638-2025·2025-10-08

    Shrimp cocktail bowls recalled over possible cesium 137 contamination at Kroger stores

    Kroger is recalling 8,400 cases of shrimp cocktail bowls made under insanitary conditions in which the product may have been contaminated with Cesium-137.

    Product
    Shrimp Cocktail Bowl; 7oz clear plastic retail packaging. UPC: 011110622952 Shrimp Cocktail Bowl; 17oz clear plastic retail packaging. UPC: 011110624840
    Category
    Food
    Distribution
    16 states
  • HighFDA (Food)·H-0010-2026·2025-10-08

    Diet green tea bottles recalled after being filled with sugared citrus tea

    PepsiCo is recalling 2,854 cases of Lipton tea because bottles labeled Diet Green Tea Mixed Berry with 0g sugar contain Green Tea Citrus with 25g sugar.

    Product
    Lipton Green Tea Citrus. 16.9 ounce PET Bottle. sold as 12pk. Outer case label reads as , "*** Lipton Green Tea Citrus (25g sugar)***" Individual bottle label reads as "*** Lipton Diet Green Tea Mixed Berry (0g sugar)***). Shelf stable.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·H-0037-2026·2025-10-08

    Vitamin B12 gummies recalled for undeclared peanuts under two brand names

    9,657 bottles of raspberry flavored vitamin B12 gummies sold as Black Girl Vitamins and Rise-N-Shine are being recalled because the product may contain undeclared peanuts.

    Product
    vitamins B12 dietary supplement Raspberry Flavored sold under the following brand names: 1. Black Girl Vitamins 60 gummies UPC 8 60008 57505 0 Manufactured for: Black Girl Vitamins 601 W Harrison St., Chicago, IL 60607. 2. Rise-N-Shine 17 Woodport Road, Sparta, NJ 07871 UPC
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0639-2025·2025-10-08

    Frozen cooked shrimp bags recalled over possible cesium 137 contamination

    Kroger is recalling 4,871 cases of frozen cooked tail-on shrimp made under insanitary conditions in which the product may have been contaminated with Cesium-137.

    Product
    16/25 Frozen Cooked Tail-On Farm Raised Shrimp; 12oz clear plastic retail bag. UPC: 011110649812 51/60 Frozen Cooked Tail-On Farm Raised Shrimp; 32oz clear plastic retail bag. UPC: 011110967015
    Category
    Food
    Distribution
    16 states
  • HighFDA (Food)·H-0001-2026·2025-10-08

    Sourdough batard bread recalled because it may contain undeclared sesame seeds

    Oven Artisans is recalling four pallets of Orwashers Soho Sourdough XL Batard because the product was mislabeled and may contain undeclared sesame seeds.

    Product
    Orwashers brand Soho Sourdough XL Batard; contains: wheat; 6-46.4oz PIECES PER CASE
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0676-2025·2025-10-08

    Glaucoma eye drops recalled over sterility assurance and bottle sealing concerns

    Apotex is recalling 151,034 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution because atypical weight loss from improper bottle sealing raises sterility concerns.

    Product
    BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION — BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2637-2025·2025-10-08

    Junctional tourniquet devices recalled over manufacturing defect affecting structural integrity

    North American Rescue is recalling 552 Junctional Emergency Treatment Tools over a potential manufacturing defect that may compromise structural integrity and performance during use.

    Product
    JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2026·2025-10-08

    Reprocessed 1.7mm laser atherectomy catheters recalled over sterile barrier breaches

    Northeast Scientific is recalling 616 reprocessed 1.7mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2026·2025-10-08

    Reprocessed 2.0mm laser atherectomy catheters recalled for sterile packaging breaches

    Northeast Scientific is recalling 141 reprocessed 2.0mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0017-2026·2025-10-08

    Dental implants recalled after import under non compliant temperature and storage conditions

    S.I.N. Implant System is recalling 4,367 Epikut Plus dental implants imported under temperature and storage conditions that do not comply with the instructions for use.

    Product
    IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2026·2025-10-08

    Reprocessed 2.0mm over the wire atherectomy catheters recalled for packaging breaches

    Northeast Scientific is recalling 199 reprocessed 2.0mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2026·2025-10-08

    Washer disinfectors recalled over overheating risk from incorrect pressure calibration

    Getinge is recalling 902 88-Series washer-disinfectors that can overheat during operation if the circulation pressure calibration was not performed, or was performed incorrectly.

    Product
    Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2026·2025-10-08

    Vascular grafts recalled after delamination reports prompt instructions for use update

    W. L. Gore is recalling 52,306 GORE ACUSEAL Vascular Grafts following reports of graft delamination, and is updating the instructions for use with expanded warnings.

    Product
    GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
    Category
    Medical Device
    Distribution
    51 states
  • HighNHTSA·25T017000·2025-10-08

    Continental Recalls Specific Tires Due to Tread Detachment Risk

    Continental is recalling specific tire models because the wrong rubber compound was used, which may cause the tread to detach and increase crash risk.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0030-2026·2025-10-08

    Radiology software recalled because reports may not display fully when viewed

    Change Healthcare is recalling 12 programs running Radiology Solutions software version 14.2.2 because a software issue means radiology reports may not be fully displayed.

    Product
    Change Healthcare Radiology Solutions software version 14.2.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0640-2025·2025-10-08

    Frozen raw shrimp recalled after product on FDA nitrofuran hold shipped

    Five cases of frozen raw easy peel shrimp are being recalled after product that was on FDA hold for high levels of nitrofuran was inadvertently distributed.

    Product
    Frozen Raw Easy Peel shrimp, IQF, 2-lb bag, 10 bags/case; Generic Brown cardboard box UPC: 021130123223
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2671-2025·2025-10-08

    Antimicrobial susceptibility test cards recalled over false colistin resistance results

    bioMerieux is recalling 235,269 VITEK 2 Gram-negative AST cards containing colistin formulation cs02n because they may give false resistant results for multi-drug-resistant organisms.

    Product
    VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export o
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0020-2026·2025-10-08

    Reprocessed 1.7mm over the wire atherectomy catheters recalled for sterility breaches

    Northeast Scientific is recalling 165 reprocessed 1.7mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2026·2025-10-08

    Reprocessed 0.9mm over the wire atherectomy catheters recalled for packaging breaches

    Northeast Scientific is recalling 561 reprocessed 0.9mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0022-2026·2025-10-08

    Reprocessed 0.9mm rapid exchange atherectomy catheters recalled for sterile barrier breaches

    Northeast Scientific is recalling 795 reprocessed 0.9mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2026·2025-10-08

    Reprocessed 1.4mm over the wire atherectomy catheters recalled for sterility breaches

    Northeast Scientific is recalling 173 reprocessed 1.4mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is no
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2673-2025·2025-10-08

    Ophthalmic imaging software recalled over measured areas smaller than actual values

    MedicalCommunications GmbH is recalling 474 units of HEYEX 2 / HEYEX PACS software because a measured value may be smaller than the actual area.

    Product
    Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0014-2026·2025-10-08

    Allura Xper CV20 X-ray systems recalled after BIOS battery halts startup

    Philips is recalling 53 Allura Xper CV20 interventional X-ray systems because the BIOS battery may deplete faster than designed, preventing the system from starting.

    Product
    Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0012-2026·2025-10-08

    Allura Xper FD20/20 X-ray systems recalled for BIOS battery startup failure

    Philips is recalling 115 Allura Xper FD20/20 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0011-2026·2025-10-08

    Allura Xper FD20/15 OR Table systems recalled over BIOS battery depletion

    Philips is recalling eight Allura Xper FD20/15 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up without warning.

    Product
    Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0005-2026·2025-10-08

    Allura Xper FD20 X-ray systems recalled over premature BIOS battery depletion

    Philips is recalling 5,067 Allura Xper FD20 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.

    Product
    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0003-2026·2025-10-08

    Allura Xper FD10/10 X-ray systems recalled for BIOS battery startup failure

    Philips is recalling 585 Allura Xper FD10/10 interventional X-ray systems because the BIOS battery may deplete faster than designed, stopping the system from starting.

    Product
    Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2638-2025·2025-10-08

    Vein ablation generators recalled over software falsely flagging working catheters

    BD is recalling 1,725 Venclose digiRF generators running software 3.35 because the catheter verification check produces false positive failures on properly functioning catheters.

    Product
    Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0008-2026·2025-10-08

    Allura Xper FD20 OR Table systems recalled over BIOS battery depletion

    Philips is recalling 298 Allura Xper FD20 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0034-2026·2025-10-08

    Collagen vascular grafts recalled over unapproved bovine raw material supplier

    LeMaitre Vascular is recalling 28 Artegraft Collagen Vascular Grafts because the bovine carotid arteries used to make them came from a supplier not reviewed and approved by the appropriate regulatory authority.

    Product
    Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0032-2026·2025-10-08

    Clinical chemistry analyzer modules recalled over stalled test status and delays

    Beckman Coulter is recalling 116 DxC 500 AU modules because a clinical chemistry sample can remain In Progress with no error when an immunoassay test is processed between chemistry tests.

    Product
    DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2640-2025·2025-10-08

    Hip stems recalled over potential mix of two catalog numbers in packaging

    Howmedica Osteonics is recalling 55 Exeter V40 hip stems because packages labeled for one catalog number may contain the other size, and patient labels may also be affected.

    Product
    1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0007-2026·2025-10-08

    Allura Xper FD20 Biplane OR Table systems recalled for BIOS battery failure

    Philips is recalling four Allura Xper FD20 Biplane OR Table systems because the BIOS battery may deplete faster than designed, stopping the system starting.

    Product
    Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0002-2026·2025-10-08

    Allura Xper FD10 X-ray systems recalled over premature BIOS battery depletion

    Philips is recalling 2,317 Allura Xper FD10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.

    Product
    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0008-2026·2025-10-08

    Raspberry peach jam cookies recalled for undeclared Red 3 and Blue 1

    Vanilla Cookies with Raspberry Peach Jam are being recalled because the colour additives Red 3 and Blue 1 are not declared on the label. The recall covers 172 cases.

    Product
    Vanilla Cookies with Raspberry Peach Jam
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0006-2026·2025-10-08

    Allura Xper FD20 Biplane systems recalled over premature BIOS battery depletion

    Philips is recalling 501 Allura Xper FD20 Biplane interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0015-2026·2025-10-08

    Allura Centron cardiovascular X-ray systems recalled over BIOS battery depletion

    Philips is recalling 313 Cardio Vascular-Allura Centron systems because the BIOS battery may deplete faster than designed, halting start-up with no warning message.

    Product
    Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0013-2026·2025-10-08

    Allura Xper FD20/20 OR Table systems recalled over BIOS battery depletion

    Philips is recalling five Allura Xper FD20/20 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0001-2026·2025-10-08

    Allura Xper FD10C X-ray systems recalled over premature BIOS battery depletion

    Philips is recalling Allura Xper FD10C interventional X-ray systems because the BIOS battery may deplete faster than designed, halting system start-up with no prior warning.

    Product
    Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide

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