The Recall Desk

Archive

August 2025 recalls

523 recalls were announced in August 2025.

What the numbers show

Critical
39
Severe
106
High
239
Moderate
138
Low
1

Of the 523 recalls this month scored against our rubric, 7% are Critical, 20% are Severe.

401–500 of 523

  • SevereNHTSA·25V502000·2025-08-06

    2018–2025 International and IC Bus vehicles recalled for fire risk

    International Motors is recalling certain 2018–2025 International 4000 Series, MV, 1300 FBC, and IC Bus TC and CECB vehicles. A leaking brake pressure switch assembly may cause an electrical short circuit that increases fire risk while driving or parked.

    Product
    IC BUS — IC BUS, INTERNATIONAL CECB, MV, 1300FBC, 4000 SERIES 4300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V504000·2025-08-06

    Freightliner Business Class M2 Steering Shaft Detachment Risk

    Fontaine Modification is recalling 2022–2024 Freightliner Business Class M2 vehicles because welds on the intermediate steering shaft may crack and fail, causing loss of steering control and crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER BUSINESS CLASS M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0347-2025·2025-08-06

    Drycapot cookies recalled over undeclared almond and macadamia tree nuts

    Drycapot cookies, net weight 1.15 oz, are being recalled because of undeclared tree nuts, specifically almond and macadamia nut. 28 units are affected.

    Product
    Drycapot cookie, net weight: 1.15 oz UPC#: 4 942737 210191
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·H-0334-2025·2025-08-06

    Sheehan Brothers pepperoni pizza mini subs recalled over undeclared sesame

    Sheehan Brothers Vending Pepperoni Pizza Mini Subs, 4.8 oz, are being recalled because of undeclared sesame. 614 individual units are affected.

    Product
    Sheehan Brothers Vending Pepperoni Pizza Mini Sub, 4.8 oz (136g), in a brown paper boat and individually wrapped in plastic, UPC: 100000222584
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2167-2025·2025-08-06

    Hamilton coaxial breathing circuits may have a crack in blue tubing

    Coaxial breathing circuit sets for HAMILTON-C1, T1 and MR1 ventilators are being recalled because the blue tubing that delivers fresh gas may be cracked, which can cause rebreathing of exhaled gases. 2,560 units affected.

    Product
    Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0333-2025·2025-08-06

    Sheehan Brothers Italian mini subs recalled over undeclared sesame

    Sheehan Brothers Vending Italian Mini Subs, 6.1 oz, are being recalled because of undeclared sesame. 696 individual units are affected.

    Product
    Sheehan Brothers Vending Italian Mini Sub, 6.1 oz (174g), in a brown paper boat and individually wrapped in plastic, UPC: 100000952412
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2159-2025·2025-08-06

    SafeStar 55 Plus breathing filters show a slow rising CO2 curve

    SafeStar 55 Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 9,885,139 units affected.

    Product
    SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2160-2025·2025-08-06

    HME TwinStar HEPA Plus filters show a slow rising CO2 curve

    HME TwinStar HEPA Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 1,019,782 units affected.

    Product
    HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0331-2025·2025-08-06

    Sheehan Brothers vending cheeseburgers recalled over undeclared sesame

    Sheehan Brothers Vending Cheeseburgers, 4.7 oz, are being recalled because of undeclared sesame. 824 individual units are affected.

    Product
    Sheehan Brothers Vending Cheeseburger, 4.7 oz (132g), individually wrapped in plastic, UPC: 100000952375
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·H-0336-2025·2025-08-06

    Sheehan Brothers BBQ riblet sandwiches recalled over undeclared sesame

    Sheehan Brothers Vending BBQ Riblet Sandwich with Coleslaw, 8 oz, is being recalled because of undeclared sesame. 209 individual units are affected.

    Product
    Sheehan Brothers Vending BBQ Riblet Sandwich with Coleslaw, 8 oz (226g), in a plastic tray/2 oz cup and individually wrapped in plastic, UPC: 100000222744
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2161-2025·2025-08-06

    SafeStar 60A Plus breathing filters show a slow rising CO2 curve

    SafeStar 60A Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 374,700 units affected.

    Product
    SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2025·2025-08-06

    SmartPath to dStream 3.0T gradient coils may act as heat source

    SmartPath to dStream for 3.0T systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 15 units affected.

    Product
    SmartPath to dStream for 3.0T Model Number (REF): 782145;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2178-2025·2025-08-06

    HarmonyAIR E-Series monitor yokes may detach from the spring arm

    Dual Flat Panel Monitor accessories for HarmonyAIR E-Series Surgical Lighting Systems are being recalled because the yoke assembly may detach from the spring arm. 59 units are affected.

    Product
    Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2223-2025·2025-08-06

    Blood agar plates may carry Listeria monocytogenes surface contamination

    Blood Agar with 5% Sheep Blood, product number R01202, is being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 1,552 units affected.

    Product
    Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2177-2025·2025-08-06

    HarmonyAIR dual flat panel monitor yokes may detach from spring arm

    Dual Flat Panel Monitor accessories for HarmonyAIR A-Series Surgical Lighting Systems are being recalled because the yoke assembly may detach from the spring arm. 167 units are affected.

    Product
    Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2025·2025-08-06

    LVP dual Y-site administration sets have potential for external cassette leaks

    LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, are being recalled because of the potential for external cassette leaks. 348,150 units are affected.

    Product
    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2205-2025·2025-08-06

    Philips Ingenia 1.5T S gradient coils may act as heat source

    Ingenia 1.5T S MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 136 units are affected.

    Product
    Ingenia 1.5T S Model Number (REF): 781347;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2218-2025·2025-08-06

    Philips MR 7700 upgrade gradient coils may act as a heat source

    Upgrade to MR 7700 systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 26 units are affected.

    Product
    Upgrade to MR 7700 Model Number (REF): 782130;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2025·2025-08-06

    Osteotec silicone finger implants may contain foreign material

    Osteotec Silicone Finger Implants in sizes 3, 4 and 5 are being recalled because there is the potential that the silicone implant may contain foreign material. 15,573 units are affected.

    Product
    Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2025·2025-08-06

    Philips MR 5300 gradient coils may act as a heat source

    MR 5300 systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 551 units are affected.

    Product
    MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2200-2025·2025-08-06

    Philips Achieva 3.0T gradient coils may act as a heat source

    Achieva 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 460 units are affected.

    Product
    Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2025·2025-08-06

    Philips Allura R8.2.x systems may temporarily lose x-ray imaging functionality

    Philips Allura R8.2.x systems are being recalled because of the potential for temporary loss of imaging (X-ray) functionality due to a software issue. 4,508 units are affected.

    Product
    Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2025·2025-08-06

    Philips MRI Machine Intera 3.0T Quasar Dual Recalled for Fire Risk

    Philips is recalling its Intera 3.0T Quasar Dual MRI system due to a potential fire hazard from gradient coil failures. The recall affects one unit distributed worldwide.

    Product
    Intera 3.0T Quasar Dual Model Number (REF): 781150;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2204-2025·2025-08-06

    Philips Ingenia 1.5T gradient coils may act as a heat source

    Ingenia 1.5T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 2,279 units are affected.

    Product
    Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0545-2025·2025-08-06

    Bicillin L-A 2.4 million unit vials recalled after particulates found

    Bicillin L-A (penicillin G benzathine injectable suspension) 2,400,000 units per 4 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 19,279 vials affected.

    Product
    BICILLIN L-A — BICILLIN L-A (PENICILLIN G BENZATHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2025·2025-08-06

    RAPIDPoint 500 wash waste cartridge lot biases seven blood analytes

    A lot of RAPIDPoint 500 Systems Wash/Waste Cartridges is being recalled because a manufacturing error causes positive and negative bias across seven analytes. 1,477 units are affected.

    Product
    RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2220-2025·2025-08-06

    Celsior cold storage solution recalled over sterility assurance during aseptic manufacturing

    Celsior Cold Storage Solution is being recalled because of the potential risk of microbiological contamination due to an inability to ensure sterility assurance throughout aseptic manufacturing. 1,532 units affected.

    Product
    Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2201-2025·2025-08-06

    Philips Achieva XR gradient coils may act as a heat source

    Achieva XR MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 40 units are affected.

    Product
    Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2199-2025·2025-08-06

    SwabFlush prefilled syringes carry SwabCaps with a compromised seal

    SwabFlush Prefilled Syringes with ICU Medical SwabCaps are being recalled because a manufacturing issue affects the SwabCap seal, which may reduce disinfection of the luer access valve. 1,427,100 units affected.

    Product
    SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2025·2025-08-06

    SmartPath to Ingenia Elition X gradient coils may overheat

    SmartPath to Ingenia Elition X systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 33 units affected.

    Product
    SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0352-2025·2025-08-06

    Blue fin tuna processed under insanitary conditions in Georgia facility

    Blue Fin Tuna sold in 50 lb boxes is being recalled because ready-to-eat fish was processed under insanitary conditions, as notified by the Georgia Department of Agriculture. 59 lb affected.

    Product
    Blue Fin Tuna, Net WT (variable weight) 50 lb brown corrugated carboard box. Boxes contain ice for temperature control. Keep Refrigerated.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·H-0351-2025·2025-08-06

    Fresh Scottish salmon fillets processed under insanitary conditions in Georgia

    Fresh Scottish Salmon Fillets sold in 50 lb boxes are being recalled because ready-to-eat fish was processed under insanitary conditions, as notified by the Georgia Department of Agriculture.

    Product
    Fresh Scottish Salmon Fillet, Net WT (variable weight) 50 lb brown corrugated carboard box (up to 6 fillets per box). Boxes contain ice for temperature control. Keep Refrigerated.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·H-0350-2025·2025-08-06

    Fresh Chilean salmon fillets processed under insanitary conditions in Georgia

    Fresh Chilean Salmon Fillets sold in 50 lb boxes are being recalled because ready-to-eat fish was processed under insanitary conditions, as notified by the Georgia Department of Agriculture.

    Product
    Fresh Chilean Salmon Fillet, Net WT (variable weight) 50 lb brown corrugated carboard box (up to 6 fillets per box). Boxes contain ice for temperature control. Keep Refrigerated.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·H-0353-2025·2025-08-06

    Yellow fin tuna processed under insanitary conditions in Georgia facility

    Yellow Fin Tuna sold in 50 lb boxes is being recalled because ready-to-eat fish was processed under insanitary conditions, as notified by the Georgia Department of Agriculture. 68.10 lb affected.

    Product
    Yellow Fin Tuna, Net WT (variable weight) 50 lb brown corrugated carboard box. Boxes contain ice for temperature control. Keep Refrigerated.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2226-2025·2025-08-06

    Blood MacConkey biplates may carry Listeria monocytogenes surface contamination

    Blood/MacConkey Biplates, product number R02049, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 611 units are affected.

    Product
    Blood/MacConkey Biplate 100/PK, Product Number R02049
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0377-2025·2025-08-06

    Reisman's cinnamon babka slices recalled over undeclared wheat and soy

    Reisman's Cinnamon Babka Slices 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Cinnamon Babka Slices 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2233-2025·2025-08-06

    LVP blood administration sets have potential for external cassette leaks

    LVP Blood Products Administration Sets are being recalled because of the potential for external cassette leaks. 14,280 units are affected.

    Product
    LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0368-2025·2025-08-06

    Reisman's cinnamon danishes recalled over undeclared wheat and soy

    Reisman's Cinnamon Danishes 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Cinnamon Danishes 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0356-2025·2025-08-06

    Reisman's jumbo chocolate chip cookies recalled over undeclared wheat

    Reisman's Jumbo Chocolate Chip Cookies 3 oz are being recalled because of undeclared wheat. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Jumbo Chocolate Chip Cookies 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2224-2025·2025-08-06

    Strep Selective II Agar plates may carry Listeria monocytogenes contamination

    Strep Selective II Agar, product number R01859, is being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 371 units are affected.

    Product
    Strep Selective II Agar, Product Number R01859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2206-2025·2025-08-06

    Philips Ingenia 3.0T gradient coils may act as a heat source

    Ingenia 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 1,467 units are affected.

    Product
    Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2234-2025·2025-08-06

    LVP primary administration sets have potential for external cassette leaks

    LVP Primary Administration Sets, Single Outlet Low Sorbing, are being recalled because of the potential for external cassette leaks. 35,925 units are affected.

    Product
    LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2025·2025-08-06

    Inseego dongle kit flash drives carry outdated patient monitor software

    Inseego USB8 4G Dongle Kits for the Tempus Pro Monitor are being recalled because the kit's USB flash drive contains outdated software that could revert the monitor and reintroduce a previous issue. 55 units affected.

    Product
    Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2025·2025-08-06

    Philips Ingenia Ambition S gradient coils may act as heat source

    Ingenia Ambition S MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 611 units are affected.

    Product
    Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2207-2025·2025-08-06

    Philips Ingenia 3.0T CX gradient coils may act as heat source

    Ingenia 3.0T CX MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 350 units are affected.

    Product
    Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0358-2025·2025-08-06

    Reisman's jumbo pink and white cookies recalled over undeclared wheat

    Reisman's Jumbo Pink & White Cookies 3 oz are being recalled because of undeclared wheat. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Jumbo Pink & White Cookies 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2188-2025·2025-08-06

    LIFEPEARL microspheres are smaller than specification, risking non-targeted embolization

    LIFEPEARL Drug Elutable Microspheres are being recalled because their actual average diameter is smaller than specification, which may lead to non-targeted embolization. 1,451 units affected.

    Product
    LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2214-2025·2025-08-06

    Philips MR 7700 gradient coils may act as a heat source

    MR 7700 systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 82 units are affected.

    Product
    MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2025·2025-08-06

    LVP dual-inlet administration sets have potential for external cassette leaks

    LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site, are being recalled because of the potential for external cassette leaks. 19,225 units are affected.

    Product
    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2216-2025·2025-08-06

    SmartPath to dStream XR gradient coils may act as heat source

    SmartPath to dStream for XR and 3.0T systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 294 units affected.

    Product
    SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0366-2025·2025-08-06

    Reisman's chocolate snack recalled over undeclared wheat and soy

    Reisman's Chocolate Snack 3 oz is being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Chocolate Snack 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2221-2025·2025-08-06

    Volcano Visions IVUS catheters can entangle with the guide wire

    Volcano Visions Digital IVUS Catheters are being recalled following reports of catheter and guide wire entanglement during radial-to-peripheral procedures, which may require surgical removal. 233,817 units affected.

    Product
    Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2025·2025-08-06

    Blood EMB Levine plates may carry Listeria monocytogenes contamination

    Blood/EMB Levine plates, product number R02041, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 750 units are affected.

    Product
    Blood/EMB, Levine 100/PK, Product Number R02041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2025·2025-08-06

    HeartSine samaritan public access defibrillators may not deliver shocks properly

    HeartSine SAM 350P, 360P and 450P public access defibrillators are being recalled because a component manufacturing issue means the device may not function properly to deliver shocks. 190,516 units affected.

    Product
    HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2209-2025·2025-08-06

    Philips Ingenia Ambition X gradient coils may act as heat source

    Ingenia Ambition X MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 690 units are affected.

    Product
    Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2198-2025·2025-08-06

    CoSense sampling sets may carry residual carbon monoxide from insufficient aeration

    Precision Sampling Sets for the CoSense End-Tidal Carbon Monoxide Monitor are being recalled because residual carbon monoxide may remain in the cannula filter, which may raise ETCOc scores. 2,160 units affected.

    Product
    Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2203-2025·2025-08-06

    Philips Evolution Upgrade 3.0T gradient coils may act as heat source

    Evolution Upgrade 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 50 units are affected.

    Product
    Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2025·2025-08-06

    Philips Ingenia Elition S gradient coils may act as a heat source

    Ingenia Elition S MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 242 units are affected.

    Product
    Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2025·2025-08-06

    Philips Evolution Upgrade 1.5T gradient coils may act as a heat source

    Evolution Upgrade 1.5T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 93 units are affected.

    Product
    Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0359-2025·2025-08-06

    Reisman's brownie bars recalled over undeclared wheat and soy

    Reisman's Brownie Bars 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Brownie Bars 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0357-2025·2025-08-06

    Reisman's jumbo black and white cookies recalled over undeclared wheat

    Reisman's Jumbo Black & White Cookies 3 oz are being recalled because of undeclared wheat. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Jumbo Black & White Cookies 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0360-2025·2025-08-06

    Reisman's fudge bars recalled over undeclared wheat and soy

    Reisman's Fudge Bars 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Fudge Bars 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0373-2025·2025-08-06

    Reisman's chocolate flaky wrap recalled over undeclared wheat and soy

    Reisman's Chocolate Flaky Wrap 3 oz is being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Chocolate Flaky Wrap 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0371-2025·2025-08-06

    Reisman's cinnamon wrap recalled over undeclared wheat and soy

    Reisman's Cinnamon Wrap 3 oz is being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Cinnamon Wrap 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0367-2025·2025-08-06

    Reisman's chocolate danishes recalled over undeclared wheat and soy

    Reisman's Chocolate Danishes 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Chocolate Danishes 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0375-2025·2025-08-06

    Reisman's soft chip cookie two-packs recalled over undeclared wheat

    Reisman's 2/pk Soft Chip Cookie with fudge filling, 3 oz, is being recalled because of undeclared wheat. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's 2/pk Soft Chip Cookie (with fudge filling) 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0378-2025·2025-08-06

    Reisman's Candy Blast brownie snacks recalled over undeclared wheat

    Reisman's Candy Blast Brownie Snack 3 oz is being recalled because of undeclared wheat. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Candy Blast Brownie Snack 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0376-2025·2025-08-06

    Reisman's chocolate babka slices recalled over undeclared wheat and soy

    Reisman's Chocolate Babka Slices 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Chocolate Babka Slices 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0364-2025·2025-08-06

    Reisman's cinnamon croissants recalled over undeclared wheat and soy

    Reisman's Cinnamon Croissants 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Cinnamon Croissants 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0370-2025·2025-08-06

    Reisman's chocolate wrap recalled over undeclared wheat and soy

    Reisman's Chocolate Wrap 3 oz is being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Chocolate Wrap 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0354-2025·2025-08-06

    Bunge European style butter blend recalled over undeclared milk allergen

    NH European Style Butter Blend from Bunge, 1 lb blocks, is being recalled because of undeclared milk. 64,800 pounds across 1,800 cases are affected.

    Product
    NH EUROPEAN STYLE BUTTER BLEND, BUNGE, NET WT 1 LB, MFD IN USA BY: Bunge Oils, Chesterfield, MO 63017, packed in white paperboard cases (36 blocks to a case) OW NH EURO BLEND SOLIDS 2015918
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·H-0361-2025·2025-08-06

    Reisman's cappuccino bars recalled over undeclared wheat and soy

    Reisman's Cappuccino Bars 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Cappuccino Bars 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0349-2025·2025-08-06

    Casa Mamita churro bites recalled after cheese stick found in bag

    Casa Mamita Churro Bites Filled with Chocolate Hazelnut Cream are being recalled for undeclared milk after a consumer found a breaded halloumi cheese stick in a bag. 19,080 sell units affected.

    Product
    Casa Mamita, Churro Bites Filled with Chocolate Hazelnut Cream, 7.5 oz , Cardboard Box, 12 boxes per case, Keep Frozen Until Ready For Use
    Category
    Food
    Distribution
    6 states
  • HighFDA (Drugs)·D-0544-2025·2025-08-06

    Bicillin L-A penicillin vials recalled after particulates found during visual inspection

    Bicillin L-A (penicillin G benzathine injectable suspension) 1,200,000 units per 2 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 50,855 vials affected.

    Product
    BICILLIN L-A — BICILLIN L-A (PENICILLIN G BENZATHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2211-2025·2025-08-06

    Philips Ingenia Elition X gradient coils may act as heat source

    Ingenia Elition X MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 632 units are affected.

    Product
    Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0345-2025·2025-08-06

    Suspiros German cake contains goat milk labeled only as milk

    Suspiros German Cake is being recalled because it contains goat milk, which was labeled simply as "milk". 93 units are affected.

    Product
    Suspiros German Cake. 15 P: 37.5 servings (2062 gr), 4P: 10 servings (550gr). UPC= 15 P: 1342, 4P: 6971. Type of packaging: Plastic dome and plate (15P and 4P). Firm name: NOVACAB SAPI de CV. Address listed on label: El paso, TX 79901, USA.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2192-2025·2025-08-06

    Phasor neurosurgical drills may have a reverse battery orientation

    The Phasor Drill, used in neurosurgical procedures, is being recalled because it may have a reverse battery orientation, which may increase surgical time. 1,064 units are affected.

    Product
    Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-2219-2025·2025-08-06

    ASPIRE Cristalle mammography systems shipped with unapproved slabbing software enabled

    ASPIRE Cristalle Mammography Systems with the Digital Breast Tomosynthesis option are being recalled because devices had an unapproved slabbing software function enabled for use. 293 units affected.

    Product
    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0381-2025·2025-08-06

    Pure Monk Fruit Sweetener bottles actually contain mislabeled stevia powder

    Pure Monk Fruit Sweetener, 0.71 oz, is being recalled because the product is stevia powder but the bottle was mislabeled as Pure Monk Fruit Sweetener. 78 bottles are affected.

    Product
    Pure Monk Fruit Sweetener, net wt. 0.71oz. UPC 7 39223 00187 6. Product is packaged in a plastic bottle with white cap. Ingredient: Monk Fruit (Luo Han Guo) Extract. Monk Fruit is so much sweeter than sugar, a pinch is all you need. Suggested Use: Add to sweeten your food or be
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0346-2025·2025-08-06

    Cajeta cupcakes contain goat milk labeled only as milk

    Cajeta cupcakes and other cake products are being recalled because they contain goat milk, which was labeled simply as "milk". 24 units are affected.

    Product
    Cajeta cupcakes (Box). Vanilla cake decorated with suspiros cream and dulce de leche-milk caramel filling. Blister plastic tray with lid (Box). Box: 6 servings (438 gr). Box: SKU89
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2196-2025·2025-08-06

    IontoPatch STAT nonwoven pads do not absorb the saline solution

    IontoPatch STAT On-the-Go Patch Therapy is being recalled because the nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with it. 80,928 units affected.

    Product
    IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2190-2025·2025-08-06

    BostonSight scleral lenses made with sagittal height or haptic errors

    BostonSight SCLERAL Lenses are being recalled because select orders were manufactured with errors impacting sagittal height, haptics, or both. 441 units are affected.

    Product
    BostonSight SCLERAL Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0380-2025·2025-08-06

    Organic Pure Stevia bottles actually contain mislabeled monk fruit powder

    Organic Pure Stevia, 1 oz, is being recalled because the product is monk fruit powder but the bottle was mislabeled as Organic Pure Stevia. 78 bottles are affected.

    Product
    Organic Pure Stevia, net wt. 1oz. UPC 7 39223 00204 0. Product is packaged in a plastic bottle with white cap. Ingredient: Organic Stevia Extract. Sprinkle a pinch for the perfect sweetness. Suggested Use: 1/64 tsp tastes as sweet as 1 tsp of sugar. Distributed by: NuNaturals, I
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2197-2025·2025-08-06

    IontoPatch 80 nonwoven pads do not absorb the saline solution

    IontoPatch 80 On-the-Go Patch Therapy is being recalled because the nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with it. 63,936 units affected.

    Product
    IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2172-2025·2025-08-06

    Sterilizable Drill Stop Kits were shipped containing incorrect components

    The Drill Stop Kit, a version of the Mini Sterilizable Tray used to store, sterilize and verify drill stop length, is being recalled because it contains incorrect components. 45 kits affected.

    Product
    The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops
    Category
    Medical Device
    Distribution
    Distributed nationwide

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