The Recall Desk

Archive

November 2025 recalls

538 recalls were announced in November 2025.

What the numbers show

Critical
62
Severe
48
High
306
Moderate
118
Low
4

Of the 538 recalls this month scored against our rubric, 12% are Critical, 9% are Severe.

301–400 of 538

  • HighFDA (Devices)·Z-0421-2026·2025-11-12

    Curved extension catheter trays recalled over header bag seal integrity

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays, 12 Fr x 13 cm, over a potential issue with the seal integrity of the header bag packaging.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0151-2026·2025-11-12

    Amoxicillin clavulanate oral suspension recalled as subpotent in the clavulanate component

    Teva Pharmaceuticals USA is recalling 4,680 cartons of Amoxicillin and Clavulanate Potassium for Oral Suspension 200 mg/28.5 mg per 5 mL because the clavulanate component is subpotent.

    Product
    Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-22
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-0426-2026·2025-11-12

    Straight extension catheter trays recalled over header bag seal integrity

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions, 12 Fr x 24 cm, over header bag seal integrity.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2026·2025-11-12

    Twenty centimetre straight catheter trays recalled over header bag seal integrity

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions, 12 Fr x 20 cm, over header bag seal integrity.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0158-2026·2025-11-12

    Cooked peeled tail off shrimp recalled over potential Cesium-137 contamination

    AquaStar is recalling 3,600 cases of Kroger Mercado Cooked Medium Peeled Tail-Off Shrimp because the shrimp may be contaminated with Cesium-137.

    Product
    Kroger Mercado Cooked Medium Peeled Tail-Off Shrimp, net wt. 2lbs. UPC 011110626196. Product is packaged in clear plastic bag and has a white label with green stripes on top of each bag.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0416-2026·2025-11-12

    Cardiology records system recalled over data saved to the wrong patient

    Spacelabs Healthcare is recalling 142 Sentinel V11 cardiology information systems because patient demographics may default to a previous patient and test data may be saved under another patient's record.

    Product
    Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardiology Information Management System is intended to connect to supported m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2026·2025-11-12

    Size G hip bearings recalled over commingled implant sizes in packaging

    Zimmer is recalling 63 Dual Mobility Vivacit-E bearings labelled Size G 46 mm because the package contents and label may be commingled with the Size F 44 mm bearing.

    Product
    Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0423-2026·2025-11-12

    Curved extension catheter trays 20 cm recalled over header bag seals

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with curved extensions, 12 Fr x 20 cm, over header bag seal integrity.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2026·2025-11-12

    Immunoassay analyzers recalled over gantry defect that pauses the instrument

    Beckman Coulter is recalling 80 UniCel DxI 600 analyzers because defective gantry sub-components can cause a z-axis motion error that halts the analyzer and delays results.

    Product
    Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0162-2026·2025-11-12

    Frozen raw white shrimp recalled over potential Cesium-137 contamination

    AquaStar is recalling 7,200 cases of AquaStar 16/20 Frozen Raw EZ-Peel White Shrimp, sold at WinCo, because the shrimp may be contaminated with Cesium-137.

    Product
    AquaStar 16/20 Frozen Raw EZ-Peel White Shrimp, net wt. 5 lbs. UPC 731149654075. Product was sold at WinCo.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0418-2026·2025-11-12

    Hip bearings recalled because size F packages contain size G implants

    Zimmer is recalling 72 Dual Mobility Vivacit-E bearings labelled Size F 44 mm because the implant inside the package is a Size G 46 mm, and the reverse also occurred.

    Product
    Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Food)·H-0161-2026·2025-11-12

    Waterfront Bistro shrimp recalled over potential Cesium-137 contamination

    AquaStar is recalling 3,600 cases of Waterfront Bistro Frozen Raw EZ-Peel White Shrimp 21/25 because the shrimp may be contaminated with Cesium-137.

    Product
    Waterfront Bistro Frozen Raw EZ-Peel White Shrimp 21/25, net wt. 2lbs., UPC 021130123223. Product was sold at Shaw s and Star Market, Albertson's, Eagle, Carrs-Safeway, and Safeway.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0151-2026·2025-11-12

    Veggie burgers recalled after equipment tested positive for Listeria

    Dr. Praeger's Sensible Foods is recalling 648 master cases of California Veggie Burgers because the product was made on equipment that tested positive for Listeria.

    Product
    Dr. Praeger's, California Veggie Burgers, 10oz, Plastic wrapped burgers inside of a retail box. 6 packages per master case. Keep Frozen
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·H-0148-2026·2025-11-12

    Crawfish stuffed potatoes recalled over undeclared Yellow 5 and Yellow 6

    Quality Poultry & Seafood is recalling 342 cases of Specialty Stuft Meats Crawfish Stuft Potato over undeclared Yellow 5 and Yellow 6 colour additives.

    Product
    Specialty Stuft Meats Crawfish Stuft Potato, Net Wt .72 lbs, individually packaged in vacuum-sealed plastic, UPC 642176000172
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0437-2026·2025-11-12

    bkActiv ultrasound systems recalled over battery guidance missing from manuals

    B-K Medical is recalling 567 Ultrasound System 2300 bkActiv units because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.

    Product
    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0435-2026·2025-11-12

    Flex Focus ultrasound carts recalled over incomplete battery safety instructions

    B-K Medical is recalling 4,426 1202 Flex Focus ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.

    Product
    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0436-2026·2025-11-12

    bkSpecto ultrasound systems recalled over battery guidance gaps in manuals

    B-K Medical is recalling 1,697 Ultrasound System 1300 bkSpecto units because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.

    Product
    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0439-2026·2025-11-12

    bk3500 ultrasound systems recalled over incomplete battery safety instructions

    B-K Medical is recalling 124 bk3500 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.

    Product
    bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0438-2026·2025-11-12

    bk3000 ultrasound systems recalled over incomplete battery replacement guidance

    B-K Medical is recalling 496 bk3000 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.

    Product
    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0440-2026·2025-11-12

    Ultrasound systems recalled over battery guidance missing from the manuals

    B-K Medical is recalling 895 bk5000 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.

    Product
    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0315-2026·2025-11-12

    T2Plus dental X-ray systems recalled over a missing certification statement

    OSSTEM Implant is correcting labeling for its Dental X-Ray System T2Plus because the certification statement required under the radiological health regulations may have been omitted.

    Product
    Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0314-2026·2025-11-12

    T2 dental X-ray systems recalled over an omitted certification statement

    OSSTEM Implant is correcting labeling for its Dental X-Ray System T2 because the certification statement required under the radiological health regulations may have been omitted.

    Product
    Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0313-2026·2025-11-12

    Dental X-ray systems recalled over a missing radiological certification statement

    OSSTEM Implant is correcting labeling for its Dental X-Ray System T1 because the certification statement required under the radiological health regulations may have been omitted.

    Product
    Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·25V773000·2025-11-10

    Nova Bus Recalls 2024-2025 LFS Transit Buses for Seat Belt Defect

    Nova Bus is recalling 2024-2025 LFS transit buses because the driver's seat belt may be pinched by the partition, preventing proper retraction and increasing injury risk.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25E074000·2025-11-07

    AROW Emergency Exit Window Latch Failure Recall

    AROW Global Corp is recalling emergency exit windows because the latch can fail during a crash, increasing the risk of passenger injury.

    Product
    STRUCTURE:EMERGENCY:ESCAPE/EGRESS/EXIT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V765000·2025-11-06

    RAM pickup trucks steering column control module air bag risk

    Chrysler is recalling certain 2021–2022 RAM 1500, 2500, 3500, 4500, and 5500 vehicles because the steering column control module may prevent the driver's side air bag from deploying in a crash, increasing injury risk.

    Product
    RAM — RAM 3500, 2500, 4500, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V766000·2025-11-06

    Jeep Grand Cherokee and Wrangler 4XE vehicles engine debris recall

    Chrysler is recalling certain 2023–2025 Jeep Grand Cherokee 4XE and 2024–2025 Jeep Wrangler 4XE vehicles due to debris inside the engine that may cause engine failure, loss of drive power, and engine compartment fire.

    Product
    JEEP — JEEP WRANGLER 4XE, GRAND CHEROKEE 4XE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V764000·2025-11-06

    GM Recalls 2014 Buick Verano and Chevrolet Cruze for Air Bag Defect

    General Motors is recalling 2,099 vehicles because side roof-rail air bag inflators may rupture, potentially causing sharp metal fragments to enter the vehicle.

    Product
    BUICK — BUICK, CHEVROLET VERANO, CRUZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V768000·2025-11-06

    GM Recalls 2019-2020 Chevrolet Silverado Medium Duty Trucks for Brake Wiring Defect

    General Motors is recalling 2019-2020 Chevrolet Silverado 4500, 5500, and 6500 trucks because a brake jumper wire harness may lack protective tape, risking power brake assist failure.

    Product
    CHEVROLET — CHEVROLET SILVERADO 6500, SILVERADO 5500, SILVERADO 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V769000·2025-11-06

    GMC Recalls 2026 Hummer EV Models Due to Air Bag Wiring Defect

    General Motors is recalling 2026 GMC Hummer EV Pickup and SUV vehicles because an improperly crimped wire may prevent the front passenger air bag from deploying.

    Product
    GMC — GMC HUMMER EV SUV, HUMMER EV PICKUP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26070·2025-11-06

    Children's scooters recalled after 18 reports of a front wheel detaching

    About 50 three-wheeled children's scooters are being recalled after 18 reports of the left front wheel detaching during use, resulting in three injuries.

    Product
    Three-Wheeled Children's Scooter with Foot Brake
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·26068·2025-11-06

    Prosecco bottles recalled after ten reports of shattering and one laceration

    About 941,400 bottles of Kirkland Signature Valdobbiadene Prosecco DOCG are being recalled because the bottles can break or shatter; ten reports include one laceration injury.

    Product
    Kirkland Signature Valdobbiadene Prosecco DOCG bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·26067·2025-11-06

    Exercise bikes recalled after seat posts broke and riders fell

    About 833,000 Peloton Original Series Bike+ units are being recalled after three reports of the seat post breaking and detaching during use, including two fall injuries.

    Product
    Peloton Original Series Bike+ Model PL02
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26074·2025-11-06

    Baby swings recalled for exceeding the incline limit for infant sleep

    About 1,020 Vevor baby swings are being recalled because they were marketed for infant sleep with an incline angle greater than 10 degrees, posing a suffocation risk.

    Product
    Vevor Baby Swings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26075·2025-11-06

    Plush alpaca toys recalled because the eyes can detach and choke

    About 64,000 Inkari plush alpaca toys are being recalled because the eyes can detach, violating the small parts ban and posing a choking hazard to children.

    Product
    Inkari Plush Alpaca Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26081·2025-11-06

    WYBITNY children's bed rails recalled over multiple entrapment openings

    About 120 WYBITNY children's portable bed rails are being recalled because a child can become entrapped in the enclosed openings and in openings beside and above the mattress.

    Product
    Children's WYBITNY Bed Rails
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V767000·2025-11-06

    2022-2024 Toyota Tundra and Lexus LX/GX Engine Failure Recall

    Toyota is recalling certain 2022–2024 Tundra and Lexus LX/GX vehicles with V35A engines due to potential manufacturing debris contamination that can cause engine failure and loss of drive power, increasing crash risk.

    Product
    LEXUS — LEXUS, TOYOTA LX, GX, TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V763000·2025-11-06

    International Recalls 2019-2020 CV Vehicles Due to Brake Harness Defect

    International is recalling 2019-2020 CV vehicles because a brake pressure switch harness may lack protective material, potentially causing a short circuit and reduced brake performance.

    Product
    INTERNATIONAL — INTERNATIONAL CV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·26069·2025-11-06

    Aftermarket crib and play yard mattresses recalled over deadly entrapment gaps

    About 117,900 Criblike aftermarket play yard and non-full-sized crib mattresses are being recalled because they may not fit properly, posing a deadly entrapment hazard.

    Product
    Criblike aftermarket play yard and non-full sized crib mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26072·2025-11-06

    Backpack blowers recalled because the fan wheel can break apart

    About 47,800 STIHL BR 800 Magnum backpack blowers are being recalled because the fan wheel inside the blower can break apart, posing a laceration hazard.

    Product
    STIHL BR 800 Backpack Blower
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26079·2025-11-06

    Bioethanol fuel containers recalled for lacking required flame mitigation devices

    About 14,000 Y'all Can DIY bioethanol fireplace fuel containers are being recalled because they lack the flame mitigation devices required under the Portable Fuel Container Safety Act.

    Product
    Y'all Can DIY Liquid Bioethanol Fireplace Fuel Containers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0163-2026·2025-11-05

    MRI operating suites recalled over ice blockage in the magnet venting system

    IMRIS is recalling the IMRIS iMRI 3T V Operating Suite because an ice blockage in the Siemens 3 Tesla magnet's venting system could rupture the helium containment system during a quench. The FDA classified it Class I.

    Product
    IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0188-2026·2025-11-05

    Distal access catheters recalled after coating material lifting inside the lumen

    Balt USA is recalling 207 MEGA Ballast Distal Access Platform catheters over a manufacturing defect in which coating material lifts within the catheter's distal lumen. The FDA has classified it Class I.

    Product
    Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flex
    Category
    Medical Device
    Distribution
    12 states
  • CriticalFDA (Food)·H-0136-2026·2025-11-05

    Chocolate nonpareils recalled over an undeclared milk allergen in bulk cases

    Weaver Nut Company is recalling 1,760 cases of semi-sweet chocolate nonpareils with white seeds over an undeclared milk allergen. The FDA has classified the recall as Class I.

    Product
    D2645 - Nonpareils, Semi-Sweet Chocolate (White Seeds), 25lb Bulk Cases Packaged into Various Size Units After distribution.
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·H-0137-2026·2025-11-05

    Frozen carrot bundt cakes recalled over an undeclared wheat allergen

    Doan's Dessert And Coffee is recalling its 4 lb Carrot Bundt Cake over an undeclared wheat allergen in ready-to-eat frozen cakes. The FDA has classified the recall as Class I.

    Product
    Carrot Bundt Cake - Net Weight 4 lbs Contains: Wheat, Soy, Milk, Eggs, Tree Nuts No UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0143-2026·2025-11-05

    Veggie spring rolls recalled over undeclared shrimp in retail cartons

    Tai Foong USA is recalling 1,261 cases of Fusia Asian Inspirations Veggie Spring Rolls over undeclared shrimp. The FDA has classified the recall as Class I.

    Product
    Fusia Asian Inspirations brand Veggie Spring Rolls. Net weight: 10 oz (283.5 g).) retail package identified by UPC 4099100222258. Type of packaging: Paperboard carton with inner poly bag; 12 ct corrugated master case. Responsible firm on label: ALDI Inc. Batavia, IL 60510 (U.S
    Category
    Food
    Distribution
    23 states
  • CriticalFDA (Devices)·Z-0164-2026·2025-11-05

    InVision operating suite recalled over ice blockage in magnet venting paths

    IMRIS is recalling the InVision 3T Operating Suite because an ice blockage in the Siemens 3 Tesla Vida magnet's venting system could rupture the helium containment system during a quench.

    Product
    IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0161-2026·2025-11-05

    Neuro operating suites recalled over ice blockage in magnet venting paths

    IMRIS is recalling the Neuro III-SV iMRI and iMRX systems because an ice blockage in the Siemens 3 Tesla Verio magnet's venting system could rupture the helium containment system during a quench.

    Product
    IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0162-2026·2025-11-05

    MRI operating suites with Skyra magnet recalled over venting system blockage

    IMRIS is recalling the IMRIS iMRI 3T S Operating Suite because an ice blockage in the Siemens 3 Tesla Skyra magnet's venting system could rupture the helium containment system during a quench.

    Product
    IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0168-2026·2025-11-05

    Bulk frozen scrambled eggs recalled over potential Listeria monocytogenes contamination

    Echo Lake Foods is recalling 824 cases, 23,072 pounds, of bulk cage free precooked scrambled eggs over potential Listeria monocytogenes contamination. The FDA classified it Class I.

    Product
    EchoLakeFoods MF 3067 CNFREE Cage Free Precooked IAF Scrambled Eggs Net Wt. 28 lbs. Bulk. Keep Frozen. Manufactured by: Echo Lake Foods, Inc., 2319 Raymond Ave. Franksville, WI 53126.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0318-2026·2025-11-05

    Glucose monitoring app recalled because it can terminate and miss alerts

    Dexcom is recalling version 1.15.0 of the G6 and G6 Pro Android CGM app because a software defect can terminate the app, stopping glucose values, alarms and alerts. The FDA classified it Class I.

    Product
    Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexc
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·H-0138-2026·2025-11-05

    White chocolate coconut bundt cakes recalled over an undeclared wheat allergen

    Doan's Dessert And Coffee is recalling its 3 lb 12 oz White Chocolate Coconut Bundt Cake over an undeclared wheat allergen. The FDA has classified the recall as Class I.

    Product
    White Chocolate Coconut Bundt Cake - Net Weight 3 lbs 12 oz Contains: Wheat, Soy, Milk, Eggs No UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0135-2026·2025-11-05

    Christmas chocolate nonpareils recalled over an undeclared milk allergen

    Weaver Nut Company is recalling 849 cases of semi-sweet chocolate nonpareils with Christmas seeds over an undeclared milk allergen. The FDA has classified the recall as Class I.

    Product
    47518 - Nonpareil, Semi-Sweet Chocolate (Christmas Seeds), 25lb Bulk Cases Packaged into Various Size Units After distribution.
    Category
    Food
    Distribution
    14 states
  • SevereNHTSA·25E073000·2025-11-05

    Bendix Recalls EC80 Electronic Control Units Due to Electrical Noise Issues

    Bendix is recalling specific EC80 Electronic Control Units because electrical noise may cause the unit to malfunction, potentially disabling critical vehicle safety systems.

    Product
    SERVICE BRAKES, AIR:ANTILOCK:CONTROL UNIT/MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0332-2026·2025-11-05

    Integrated drip chamber administration sets recalled over port weld separation risk

    ICU Medical is recalling 11,000 administration sets with a 20-drop integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.

    Product
    ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0341-2026·2025-11-05

    Chemotherapy bag spikes recalled because port weld may separate and leak

    ICU Medical is recalling 7,850 ChemoLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Bag Spike REF: CL-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0109-2026·2025-11-05

    Desipramine 50 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 5,880 bottles of Desipramine Hydrochloride Tablets USP 50 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0342-2026·2025-11-05

    Double port syringe transfer sets recalled over port weld separation risk

    ICU Medical is recalling 4,000 Double ChemoLock Port Syringe Transfer Sets because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0338-2026·2025-11-05

    Anti-siphon smallbore extension sets recalled over port weld separation risk

    ICU Medical is recalling 950 45-inch smallbore extension sets with an anti-siphon valve because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2026·2025-11-05

    Pyxis Pro auxiliary drawers recalled over fluid ingress causing smoke or fire

    CareFusion is recalling 32 BD Pyxis Pro 7-Drawer Auxiliary units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.

    Product
    Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2026·2025-11-05

    Purple cap administration sets recalled over port weld separation risk

    ICU Medical is recalling 11,000 31-inch administration sets with an integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.

    Product
    ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0322-2026·2025-11-05

    SyncAR navigation platform recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling 14 units of its SyncAR SNAP platform because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2026·2025-11-05

    Parathyroid hormone assay recalled over falsely depressed results at low range

    Siemens Healthcare Diagnostics is recalling 3,318 units of the IMMULITE 2000 Intact PTH assay over the potential for falsely depressed patient results at the low end of the assay range.

    Product
    Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2026·2025-11-05

    20mm vented vial spikes recalled over port weld separation risk

    ICU Medical is recalling 11,200 ChemoLock Vented Vial Spikes, 20mm, because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2026·2025-11-05

    Cardiac control material recalled over vial to vial troponin variability

    Microgenics is recalling 4,462 units of Thermo Scientific MAS Omni CARDIO control after customers reported vial-to-vial variability with high sensitivity Troponin I assays.

    Product
    Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0316-2026·2025-11-05

    Soft tissue markers recalled over potential contamination with cotton fibers

    Endomagnetics is recalling 1,760 Magseed Pro 7 cm soft tissue markers because of the potential for contamination with cotton fibers.

    Product
    Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0355-2026·2025-11-05

    Mini bag spike connectors recalled over port weld separation risk

    ICU Medical is recalling 400 ChemoLock connectors with Mini Bag Spike because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2026·2025-11-05

    Universal vented vial spikes recalled over port weld separation risk

    ICU Medical is recalling 16,850 ChemoLock Universal Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2026·2025-11-05

    Graduated adapter extension sets recalled over port weld separation risk

    ICU Medical is recalling 5,700 7.5-inch extension sets with a ChemoLock port and graduated adapter because the port weld may separate or break during use and leak.

    Product
    ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2026·2025-11-05

    Dialysis connectivity software recalled because prescription changes may not reach cyclers

    Vantive is recalling the Sharesource Connectivity Platform for Homechoice Claria because a software defect may stop updated prescription settings from saving on the patient's cycler.

    Product
    Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0137-2026·2025-11-05

    Testosterone and triamcinolone 200 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 264,664 sterile Testosterone / Triamcinolone Acetonide 200MG/40MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2026·2025-11-05

    Six inch extension sets recalled because port weld may separate and leak

    ICU Medical is recalling 1,600 6-inch extension sets with MicroClave Clear and ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0101-2026·2025-11-05

    Unit dose prazosin 1 mg cartons recalled over nitrosamine impurity

    Amerisource Health Services is recalling 1,970 unit dose cartons of Prazosin Hydrochloride Capsules 1 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0102-2026·2025-11-05

    Unit dose prazosin 2 mg cartons recalled over nitrosamine impurity

    Amerisource Health Services is recalling 1,818 unit dose cartons of Prazosin Hydrochloride Capsules 2 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0142-2026·2025-11-05

    Frozen riced cauliflower recalled over potential Listeria monocytogenes contamination

    Nate's Fine Foods is recalling 336 cases, 10,080 pounds, of 30-pound bulk frozen riced cauliflower over potential contamination with Listeria monocytogenes.

    Product
    RICED CAULIFLOWER IQF NET WEIGHT: 30lbs (13.60 kg) PACK DATE: 08/04/2025 BEST BY: 08/04/2026 INGREDIENTS: CAULIFLOWER PERISHABLE KEEP FROZEN
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0304-2026·2025-11-05

    Vitrectomy probe accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 577 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2026·2025-11-05

    Controlled substance safe towers recalled over fluid ingress causing smoke or fire

    CareFusion is recalling 443 BD Pyxis CII Safe ES Tower Main units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.

    Product
    All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2026·2025-11-05

    ChemosafeLock bag spikes recalled over port weld separation risk

    ICU Medical is recalling 134,700 ChemosafeLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0320-2026·2025-11-05

    Surgical navigation platform recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling 17 units of its Surgical Navigation Advanced Platform because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0336-2026·2025-11-05

    Oncology kits with ChemoLock port recalled over port weld separation

    ICU Medical is recalling 150 Oncology Kits with ChemoLock and ChemoLock Port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0146-2026·2025-11-05

    Roasted mixed nuts recalled over hazelnuts missing from the allergen statement

    Severn Peanut Company is recalling 528 cases of 8 oz Roasted No Salt Mixed Nuts after finding hazelnuts were not listed in the allergen statement.

    Product
    MIXED NUTS Roasted No Salt NET WT 8 OZ (227g) INGREDIENTS: ALMONDS, WALNUTS, PEANUTS***CASHEWS***HAZELNUTS, BRAZIL NUTS CONTAINS: ALMONDS, BRAZIL NUTS, CASHEWS, PEANUTS, WALNUTS UPC 8 10111 02237 8 DIST BY: HAMPTON FARMS 180 AVOCADO ST. SPRINGFIELD, MA 01104
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0143-2026·2025-11-05

    Sodium chloride injection bags recalled over potential flexible container leaks

    Otsuka ICU Medical is recalling 509,360 100 mL bags of 0.9% Sodium Chloride Injection from one lot for lack of assurance of sterility due to potential flexible container leaks.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0337-2026·2025-11-05

    Oncology transfer kits recalled over port weld separation risk

    ICU Medical is recalling 600 Oncology Transfer Kits with ChemoClave and ChemoLock ports because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0104-2026·2025-11-05

    Prazosin 1 mg capsules recalled over nitrosamine impurity above intake limit

    Teva Pharmaceuticals USA is recalling 181,659 bottles of Prazosin Hydrochloride Capsules 1 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0345-2026·2025-11-05

    13mm vented vial spikes recalled over port weld separation risk

    ICU Medical is recalling 9,004 ChemoLock Vented Vial Spikes, 13mm, because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0135-2026·2025-11-05

    Testosterone and triamcinolone 87.5 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 21,324 sterile Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0127-2026·2025-11-05

    Testosterone 200 mg pellets recalled over potential presence of metal particulate

    FarmaKeio Outsourcing is recalling 4,929 sterile Testosterone 200 mg pellets over the potential presence of metal particulate matter.

    Product
    Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0381-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0113-2026·2025-11-05

    Compounded pain injection syringes recalled over presence of particulate matter

    QuVa Pharma is recalling 75,885 syringes of its R.E.C.K. periarticular injection over the presence of particulate matter.

    Product
    R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land,
    Category
    Drug
    Distribution
    Distributed nationwide

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