The Recall Desk

Archive

February 2025 recalls

506 recalls were announced in February 2025.

What the numbers show

Critical
7
Severe
125
High
354
Moderate
20

Of the 506 recalls this month scored against our rubric, 1% are Critical, 25% are Severe.

301–400 of 506

  • HighFDA (Devices)·Z-1046-2025·2025-02-12

    X-Ray Imaging System May Continue Exposure Beyond Safety Limit

    GE Medical Systems' Optima XR646 HD X-Ray imaging systems may allow continued radiation exposure beyond the safety limit without operator confirmation. A warning message displays but does not prevent the excess exposure.

    Product
    Optima XR646 HD. X-Ray imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V078000·2025-02-12

    Porsche Recalls 2023 911 Models Due to Rear Seat Belt Bolt Issue

    Porsche is recalling 2023 911 vehicles because rear seat belt buckle bolts may not be tightened properly, which could reduce occupant restraint during a crash.

    Product
    PORSCHE — PORSCHE 911
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0507-2025·2025-02-12

    ESL Cinnamon Fries Recalled for Potential Listeria Contamination

    ESL Cinnamon Fries (item 8201871) produced on December 13, 2024 and prior are being recalled due to potential contamination with Listeria monocytogenes. Approximately 2 million cases were distributed nationwide in the US and Canada.

    Product
    item 8201871 ESL CINNAMON FRIES 60x3OZ, NET WT 10.13 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0520-2025·2025-02-12

    Yeast Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling yeast donuts nationwide and in Canada due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.

    Product
    item 8201919 BAR YST DONUT UNFLD PFD 74x3OZ, NET WT 12.49 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0493-2025·2025-02-12

    Frozen Persian Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling frozen Persian donuts due to potential Listeria monocytogenes contamination. The recall affects 2,017,614 cases distributed nationwide in the US and Canada.

    Product
    item 8201844 GEN GLD PERSIAN DONUT DGH FRZ 132x2.5OZ, NET WT 18.56 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1081-2025·2025-02-12

    Philips AlluraXper FD20 Biplane Patient Table Finger Entrapment Risk

    Philips AlluraXper FD20 Biplane patient tables may cause finger entrapment between the tabletop and guiding rails during manual repositioning, affecting operators and service personnel.

    Product
    AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0219-2025·2025-02-12

    Hydralazine Hydrochloride Tablets Recalled Due to Impurities and Degradation

    SKY Packaging recalls Hydralazine Hydrochloride 25 mg tablets nationwide due to failed quality specifications for impurities and degradation.

    Product
    HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0529-2025·2025-02-12

    FGF Vanilla Mini Cake Donut Rings Recalled for Listeria Contamination Risk

    FGF, LLC is recalling 2,017,614 cases of vanilla mini cake donut rings due to potential Listeria monocytogenes contamination. The affected product was produced on or before December 13, 2024, and distributed nationwide in the US and Canada.

    Product
    item 8202891 PLAIN VANILLA MINI CAKE DONUT RING BULK 240X1.25OZ, NET WT 16.88 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0215-2025·2025-02-12

    Prescription Carvedilol recalled for manufacturing impurity exceeding FDA specifications

    Glenmark Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide due to a manufacturing quality issue with impurity levels exceeding FDA recommended limits. Multiple lot numbers and expiration dates from February 2025 through February 2026 are affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1080-2025·2025-02-12

    Philips recalls AlluraXper FD20 patient tables due to finger entrapment hazard

    Philips is recalling AlluraXper FD20 patient tables due to a finger entrapment hazard. During manual repositioning, fingers can get trapped between the tabletop and rails, risking injury to operators and service personnel.

    Product
    AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0480-2025·2025-02-12

    French Crullers Recalled Nationwide for Potential Listeria Contamination

    FGF, LLC is recalling French Crullers sold nationwide and in Canada due to potential Listeria monocytogenes contamination. All product with expiration dates from 12/13/24 and earlier is affected.

    Product
    item 8201812 FRENCH CRULLERS 72x 1.6 OZ, NET WT 6.48 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0506-2025·2025-02-12

    FGF Fluff Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling 2,017,614 cases of item 8201870 Fluff Donuts due to potential Listeria monocytogenes contamination. The affected product was produced on or before December 13, 2024, and distributed nationwide in the US and Canada.

    Product
    item 8201870 GEN BAR FLUFF DONUT ZGT PFD 78x3OZ, NET WT 13.16 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1107-2025·2025-02-12

    Patient Monitor May Fail to Alarm on Ventilator Disconnect

    Philips IntelliVue Patient Monitor MX400 may fail to alarm when a Hamilton ventilator is disconnected. 28 units affected in the US and internationally.

    Product
    IntelliVue Patient Monitor MX400. Model Number: 866060
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0483-2025·2025-02-12

    Raspberry Paczki Recalled Nationwide for Potential Listeria Monocytogenes Contamination

    FGF, LLC is recalling 2,017,614 cases of Naturally and Artificially Flavored Raspberry Paczki nationwide due to potential contamination with Listeria monocytogenes. Consumers should not consume the product.

    Product
    item 8201815 NATURALLY AND ARTIFICIALLY FLAVORED RASPBERRY PACZKI 66x4 OZ, NET WT 14.85 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0503-2025·2025-02-12

    FGF Pumpkin Cake Rings Recalled Due to Listeria Contamination Risk

    FGF's Just Baked Pumpkin Cake Rings are being recalled due to potential listeria monocytogenes contamination. Consumers should discard the product or return it to the point of purchase.

    Product
    item 8201866 JUST BAKED PUMPKIN CAKE RINGS 144x2.45 OZ, NET WT 22.05 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0526-2025·2025-02-12

    Apple Fritter Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling Apple Fritter Donuts (item 8201927) due to potential Listeria monocytogenes contamination. The recall affects 2,017,614 cases distributed nationwide in the US and Canada.

    Product
    item 8201927 APPLE FRITTER DONUT PFD 70 X 3.5OZ, NET WT 13.78 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2025·2025-02-12

    Dental implants recalled for manufacturing defect affecting sterile packaging

    Nobel Biocare recalled N1 TiUltra TCC dental implants due to a manufacturing defect that may puncture the sterile blister packaging. The defect is a sharp pin created during injection molding that could compromise product sterility.

    Product
    . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0513-2025·2025-02-12

    FGF Persian Yeast Donuts Recalled Nationwide for Potential Listeria Contamination

    FGF, LLC is recalling Persian yeast donuts due to potential Listeria monocytogenes contamination. The recall affects all product produced on or before December 13, 2024.

    Product
    item 8201884 PERSIAN YST DONUT PFD 46x3.5 OZ, NET WT 9.06 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0528-2025·2025-02-12

    Unfilled Bismarck Donuts Recalled Due to Listeria Contamination Risk

    FGF, LLC is recalling over 2 million cases of unfilled Bismarck donuts due to potential Listeria monocytogenes contamination. The recall affects products distributed nationwide in the US and Canada.

    Product
    item 8202731 UNFLD BISMARK DONUT PFD 78X3OZ, NET WT 13.16 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0482-2025·2025-02-12

    Bavarian Paczki Recalled for Listeria Monocytogenes Contamination Risk

    FGF, LLC is recalling Bavarian Paczki (item 8201814) due to potential Listeria monocytogenes contamination. The recall affects 2,017,614 cases distributed nationwide in the US and Canada.

    Product
    item 8201814 BAVARIAN PACZKI 66x4OZ, NET WT 14.85 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0460-2025·2025-02-12

    Monkey Spit BBQ Sauce recalled for undeclared milk allergen

    Monkey Spit Monkey Mop BBQ Sauce is recalled because it contains undeclared milk from butter, a common allergen. Consumers with milk allergies should not consume this product.

    Product
    Monkey Spit "Monkey Mop" BBQ Sauce, 12 fl oz (355ml) glass bottle, 12 bottles/case; Refrigerate after opening; Manufactured by Smith House MFG. 146-A S. Thompson Ave. Nipomo, CA 93444 (805)619-7959 Monkey Spit, LLC, UPC#8 54540 00206 8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0487-2025·2025-02-12

    JUST BAKED Yeast Munchkins Recalled for Potential Listeria Contamination

    FGF, LLC is recalling JUST BAKED Yeast Munchkins nationwide due to potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    item 8201835 JUST BAKED YEAST MUNCHKINS 350x0.39 OZ, NET WT 8.49 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1113-2025·2025-02-12

    Sysmex PS-10 Sample Preparation System Recalled for False Test Results

    Sysmex PS-10 Sample Preparation Systems may produce false test results due to sporadic omission of the probe wash step during antibody pipetting. Thirty-two units have been recalled nationwide.

    Product
    Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0502-2025·2025-02-12

    Just Baked Apple Fritters Recalled Due to Listeria Contamination Risk

    FGF, LLC is recalling Just Baked Apple Fritters nationwide due to potential Listeria monocytogenes contamination. Consumers should discard affected products.

    Product
    item 8201865 JUST BAKED APPLE FRITTERS 72x3OZ, NET WT 13.50 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0524-2025·2025-02-12

    Donut Product Recalled for Potential Listeria Monocytogenes

    FGF, LLC is recalling approximately 2 million cases of its BAV CRM BAR DONUT product nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume the product and should dispose of it or return it to the retailer.

    Product
    item 8201923 BAV CRM BAR DONUT PFD 78 X 3OZ, NET WT 13.16 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0500-2025·2025-02-12

    Just Baked Eclairs Recalled Nationwide Due to Listeria Contamination Risk

    FGF, LLC is recalling Just Baked Eclairs nationwide in the US and Canada due to potential Listeria monocytogenes contamination. All products produced on 12/13/24 or earlier are affected.

    Product
    item 8201863 JUST BAKED ECLAIRS 84x2.36 OZ, NET WT 12.39 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2025·2025-02-12

    Philips AlluraXper FD20 operating room surgical table finger entrapment risk

    Philips AlluraXper FD20 operating room tables can trap fingers during manual repositioning, risking injury. The hazard affects both operators and service personnel worldwide.

    Product
    AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0521-2025·2025-02-12

    FDA Recalls Apple Crisp Cake Donuts for Potential Listeria Contamination

    FGF, LLC recalls Apple Crisp Cake Donuts for potential Listeria monocytogenes contamination. Approximately 2,017,614 cases are affected.

    Product
    item 8201920 APPLE CRISP CK DONUT PFD 78x3OZ, NET WT 13.16 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0496-2025·2025-02-12

    Frozen donuts recalled for potential listeria monocytogenes contamination

    FGF, LLC is recalling frozen donuts nationwide due to potential contamination with listeria monocytogenes. Consumers should not consume the product and should discard or return it.

    Product
    item 8201848 GEN HEX RG DONUT DGH FRZ 96x2.75OZ, NET WT 14.86 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1115-2025·2025-02-12

    Beckman Coulter DxI 9000 immunoassay analyzer recalled for software-related motion errors

    Beckman Coulter is recalling 61 DxI 9000 immunoassay analyzers worldwide due to a software error causing tray gripper motion errors that result in intermittent hard stops and delays in patient test results.

    Product
    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0465-2025·2025-02-12

    FDA Recalls Greenwise Organic Pecan Halves for Undeclared Walnuts

    The FDA has recalled Greenwise Organic Pecan Halves (8-ounce bags) due to undeclared walnuts, a major allergen. The affected product was distributed in eight southeastern states.

    Product
    Greenwise Organic Pecan Halves 8 ounce, plastic printed package marked with lot # 18228 and with a best by date of April.23.2025 stamped on front UPC: 041415212336
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1109-2025·2025-02-12

    IntelliVue Patient Monitor MX500 may fail to generate critical alarms

    Philips IntelliVue Patient Monitor MX500 units may fail to generate "No Device Data" alarms when a Hamilton ventilator disconnects, potentially delaying notification of loss of connectivity. 45 units distributed in the US and internationally.

    Product
    IntelliVue Patient Monitor MX500. Model Number: 866064
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·25V079000·2025-02-12

    Porsche Recalls 2025 911 Models Due to Headlight Glare Software Error

    Porsche is recalling 878 2025 911 vehicles because a software error causes low beam headlights to create excessive glare for oncoming traffic, increasing crash risk.

    Product
    PORSCHE — PORSCHE 911
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1118-2025·2025-02-12

    Spine Surgery Planning Software Calculation Errors in Rod Planning Parameters

    Medicrea International is recalling UNiD Spine Analyzer software due to calculation errors in rod planning parameters. The software experienced anomalies resulting in incorrect values for surgical classification and measurement parameters used in spine surgery planning.

    Product
    UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a…
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1111-2025·2025-02-12

    Temporary Titanium Abutments May Fracture in Dental Implants

    DDS Lab temporary titanium abutments may have been installed in some dental implant restoration cases instead of definitive abutments. The components may fracture, risking restoration loosening, oral tissue injury, and aspiration.

    Product
    Temporary Titanium Abutments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1044-2025·2025-02-12

    Medical X-Ray System Permits Bypass of Radiation Exposure Control

    GE Medical Systems' Discovery XR656HD X-Ray imaging systems can allow radiation exposures to exceed the Automatic Exposure Control limit without blocking further exposure. Approximately 3,149 units are affected worldwide, including 1,697 in the United States.

    Product
    Discovery XR656HD. X-Ray imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-02122025-01·2025-02-12

    Frozen Ready-to-Eat Meat and Poultry Pasties Recalled for Undeclared Egg Allergen

    USDA FSIS issued a public health alert for The Pasty Oven frozen pasties due to an undeclared egg allergen. No illnesses have been reported.

    Product
    The Pasty Oven, Inc. — FSIS Issues Public Health Alert for Frozen Ready-To-Eat Meat and Poultry Pasties Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1095-2025·2025-02-12

    Hologic Rapid fFN Specimen Collection Tubes May Contain Incorrect Extraction Buffer Volumes

    Hologic Rapid fFN Specimen Collection Tubes from three lots may contain incorrect amounts of extraction buffer, potentially causing invalid test results or diagnostic errors in preterm delivery assessment.

    Product
    The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2025·2025-02-12

    ECG cable shipped with incomplete cleaning and disinfection instructions

    Physio-Control is recalling 245 LIFEPAK 35 ECG cables (Lot 0224) because the shipped instructions do not include proper cleaning and disinfection procedures, creating potential cross-contamination risks.

    Product
    LIFEPAK 35 ECG cable REF 11111-000041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0505-2025·2025-02-12

    FGF Twist Donuts Recalled Due to Listeria Contamination Risk

    FGF's Twist Donuts are being recalled nationwide in the US and Canada due to potential Listeria monocytogenes contamination. The recall affects approximately 2 million cases produced on or before December 13, 2024.

    Product
    item 8201868 GEN TWIST DONUT ZGT PFD 84x1.75 OZ, NET WT 12.93 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2025·2025-02-12

    Philips AlluraXper Operating Room Table Finger Entrapment Hazard

    The Philips AlluraXper FD20 operating room table can trap fingers between the guiding rails and tabletop during manual repositioning, potentially injuring operators and service personnel.

    Product
    AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0512-2025·2025-02-12

    FGF LLC Recalls Unfilled Bismarck Donuts for Listeria Contamination Risk

    FGF LLC is recalling 2,017,614 cases of unfilled Bismarck donuts nationwide due to potential listeria monocytogenes contamination. Consumers should not consume the affected product.

    Product
    item 8201883 UNFLD BISMARK DONUT PFD 57x2.75OZ, NET WT 8.82 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1076-2025·2025-02-12

    Philips Allura CV20 patient tables risk finger entrapment during repositioning

    The Philips Allura CV20 System patient tables (AD7 and AD7X models) pose a finger entrapment hazard during manual repositioning. Fingers can become caught between the tabletop and guiding rails, potentially injuring operators and service personnel.

    Product
    Allura CV20 System Code: 722031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V081000·2025-02-12

    Volkswagen Atlas transmissions may have been manufactured incorrectly

    Volkswagen is recalling certain 2025 Atlas and Atlas Cross Sport vehicles because the transmission may have been manufactured incorrectly, which can result in a loss of drive power.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS, ATLAS CROSS SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0220-2025·2025-02-12

    HydrALAZINE Hydrochloride tablets recalled for failed purity and degradation specifications

    SKY PACKAGING is recalling HydrALAZINE Hydrochloride 50mg tablets nationwide due to failed impurities and degradation specifications. Four affected lot numbers have expiration dates from April 2025 to February 2026.

    Product
    HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0504-2025·2025-02-12

    Just Baked Pumpkin Cake Munchkins recalled for potential Listeria contamination

    FGF, LLC is recalling Just Baked Pumpkin Cake Munchkins nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume this product.

    Product
    item 8201867 JUST BAKED PUMPKIN CAKE MUNCHKINS 440x0.47 OZ, NET WT 12.93 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0498-2025·2025-02-12

    FGF LLC Just Baked Cake Rings Recalled for Potential Listeria Contamination

    FGF, LLC recalls approximately 2,017,614 cases of Just Baked Cake Rings distributed nationwide due to potential contamination with Listeria monocytogenes.

    Product
    item 8201859 JUST BAKED CAKE RING 144x2.45 OZ, NET WT 22.05 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2025·2025-02-12

    Philips Azurion and Allura Patient Tables: Finger Entrapment Hazard

    Philips patient tables on Azurion and Allura imaging systems can trap fingers between the tabletop and rails during manual repositioning. Operators and service personnel are at risk of finger injury.

    Product
    Azurion 3 M12 System Code: (1) 722063 (2) 722221
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0501-2025·2025-02-12

    FGF LLC Recalls Just Baked Coffee Rolls Over Listeria Contamination Risk

    FGF LLC is recalling 2,017,614 cases of Just Baked Coffee Rolls (78 x 3oz packages) due to potential Listeria monocytogenes contamination. The affected product was produced on or before 12/13/24 and distributed nationwide in the US and Canada.

    Product
    item 8201864 JUST BAKED COFFEE ROLLS 78x3OZ, NET WT 14.62 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0485-2025·2025-02-12

    Apple-Filled Paczki from FGF, LLC recalled for potential Listeria contamination

    FGF, LLC is recalling apple-filled paczki sold nationwide due to potential contamination with Listeria monocytogenes. Affected units were produced on or before December 13, 2024.

    Product
    item 8201817 APPLE FILLED PACZKI 66x4 OZ, NET WT 14.85 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2025·2025-02-12

    IntelliBridge EC10 Module may fail to alarm on ventilator disconnection

    The IntelliBridge EC10 Module may fail to sound an alarm when a Hamilton ventilator is disconnected. This could allow unnoticed disconnections that could affect patient monitoring.

    Product
    IntelliBridge EC10 Module. Model Number: 865115
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1079-2025·2025-02-12

    Philips Allura patient tables recall due to finger entrapment risk

    Philips recalls AD7 and AD7X patient tables in Allura and Azurion systems due to finger entrapment risk during manual repositioning. Operators and service personnel could suffer finger injuries.

    Product
    Allura Xper FD10C System Code: (1) 722001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2025·2025-02-12

    GE Discovery XR656 HD X-ray system AEC control malfunctions during imaging

    GE Medical Systems is recalling the Discovery XR656 HD X-ray imaging system due to a malfunction in the Automatic Exposure Control (AEC) feature. The defect allows continued X-ray exposure beyond intended limits without requiring operator acknowledgment.

    Product
    Discovery XR656 HD. X-Ray imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0491-2025·2025-02-12

    Frozen Donuts Recalled Due to Listeria Contamination Risk

    FGF, LLC is recalling 2,017,614 cases of frozen donuts nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume this product.

    Product
    item 8201842 GEN BAR DONUT DGH FRZ 132x2OZ, NET WT 14.85 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0517-2025·2025-02-12

    FGF Chocolate Cake Rings Recalled for Potential Listeria Contamination

    FGF, LLC is recalling 2,017,614 cases of JUST BAKED Chocolate Cake Rings distributed nationwide in the US and Canada due to potential Listeria monocytogenes contamination.

    Product
    item 8201904 JUST BAKED CHOCOLATE CAKE RINGS ARTIFICIALLY FLAVORED 144x2.5OZ, NET WT 22.5 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1090-2025·2025-02-12

    Philips Azurion 5 M20 Patient Tables Recalled for Finger Entrapment Hazard

    Philips Azurion 5 M20 x-ray system patient tables can trap fingers between the tabletop and guiding rails during repositioning. The hazard may cause finger injury to operators and service personnel.

    Product
    Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0522-2025·2025-02-12

    French Cruller Recall Due to Listeria Contamination Risk

    FGF, LLC is recalling French Crullers (item 8201921) distributed nationwide in the US and Canada due to potential Listeria monocytogenes contamination.

    Product
    item 8201921 FRENCH CRULLER PFD 72x1.6 OZ, NET WT 6.48 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1078-2025·2025-02-12

    Philips AlluraXper Patient Tables Pose Finger Entrapment Risk

    Philips is recalling AD7 and AD7X patient tables used in Allura and Azurion fluoroscopy systems. Manual repositioning can trap fingers between the tabletop and rails, risking injury to operators and service personnel.

    Product
    AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0479-2025·2025-02-12

    Sour Cream Cake Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling Old Fashioned Sour Cream Cake Donuts due to potential Listeria monocytogenes contamination. The recall affects 2,017,614 cases distributed nationwide in the US and Canada.

    Product
    item 8201811 OLD FASHIONED NATURALLY AND ARTIFICIALLY FLAVORED SOUR CREAM CAKE DONUTS 90x2.5 OZ, NET WT 12.66 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0518-2025·2025-02-12

    Just Baked Blueberry Cake Ring Recalled for Potential Listeria Contamination

    FGF, LLC is recalling Just Baked Blueberry Cake Ring products for potential Listeria monocytogenes contamination. Approximately 2.0 million cases distributed nationwide to the US and Canada with production dates on or before December 13, 2024.

    Product
    item 8201905 JUST BAKED BLUEBERRY CAKE RING NATURALLY AND ARTIFICIALLY FLAVORED 135x2.5OZ, NET WT 21.09 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1105-2025·2025-02-12

    NeiMed NasoGel nasal spray recalled due to stability failure

    Neilmed Pharmaceuticals is recalling NasoGel for Dry Noses due to stability failure that may allow microbial growth. The product was distributed across 30 U.S. states and to five countries.

    Product
    NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0490-2025·2025-02-12

    Frozen Persian Donuts Recalled Due to Listeria Contamination Risk

    FGF, LLC is recalling frozen Persian donuts nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.

    Product
    item 8201841 GEN PERSIAN DONUT DGH FRZ 168x2OZ, NET WT 18.90 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1114-2025·2025-02-12

    Endodontic Files Recalled for Excess Irradiation Causing Package Integrity Issues

    US Endodontics is recalling endodontic files due to irradiation above specification, which may compromise package integrity. The recall affects 789,729 devices distributed in the US and internationally.

    Product
    Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP145253PK AP145313PK AP1GP213PK AP1GP253PK AP1GP313PK O.U.S. Products: EdgeFile X7…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0473-2025·2025-02-12

    Apple fritter recall due to potential Listeria monocytogenes contamination

    FGF LLC is recalling apple fritters nationwide due to potential Listeria monocytogenes contamination. All product produced on or before December 13, 2024 is affected.

    Product
    item 8201805 APPLE FRITTER 60x2.5 OZ, NET WT 8.44 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0481-2025·2025-02-12

    FGF Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling dual-filled chocolate and Bavarian yeast ring donuts due to potential Listeria monocytogenes contamination. The recall affects 2,017,614 cases distributed in the US and Canada.

    Product
    item 8201813 DUAL FILLED NATURALLY & ARTIFICIALLY FLAVORED CHOCOLATE AND BAVARIAN FILLED YEAST RING DONUT 80x3.1OZ, NET WT 13.97 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0511-2025·2025-02-12

    French Crullers Recalled for Potential Listeria Contamination

    FGF, LLC is recalling JUST BAKED FRENCH CRULLERS nationwide due to potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    item 8201882 JUST BAKED FRENCH CRULLERS 96x1.6 OZ, NET WT 9.60 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2025·2025-02-12

    VNS Therapy Generators May Stop Delivering Stimulation Due to Component Failure

    The SenTiva and SenTiva Duo vagus nerve stimulation generators may stop delivering therapy due to an internal mechanical component becoming stuck, causing potential loss of seizure and depression control.

    Product
    SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
    Category
    Medical Device
    Distribution
    41 states
  • HighNHTSA·25V080000·2025-02-12

    Audi Q5 and A7 high voltage batteries may overheat

    Volkswagen is recalling certain 2021-2024 Audi Q5 and 2022 A7 e plug-in hybrid vehicles because the high-voltage battery may overheat, increasing the risk of a fire.

    Product
    AUDI — AUDI Q5, A7 E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0510-2025·2025-02-12

    FGF Donuts Recalled Nationwide Due to Listeria Contamination Risk

    FGF ring donuts recalled nationwide for potential Listeria monocytogenes contamination. The recall covers 2,017,614 cases produced through December 13, 2024.

    Product
    item 8201879 RING RND DONUT ZGT PDF 96x2.25 OZ, NET WT 12.15 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0499-2025·2025-02-12

    FGF Sour Cream Cake Donuts Recalled Due to Listeria Contamination Risk

    FGF's Just Baked Sour Cream Cake Donuts are being recalled nationwide due to potential Listeria monocytogenes contamination. Approximately 2 million cases produced on or before December 13, 2024 are affected.

    Product
    item 8201860 JUST BAKED SOUR CREAM CAKE DONUTS 120x2.5 OZ, NET WT 18.75 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1097-2025·2025-02-12

    PERMA-HAND Silk Sutures Recalled for Packaging Sterility Breach

    Ethicon is recalling PERMA-HAND Silk Sutures that may have open seals on packaging due to manufacturing defects, risking sterility compromise and patient infection. Approximately 78,792 units were distributed nationwide and internationally.

    Product
    PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0478-2025·2025-02-12

    Fluff Bars Recalled Due to Potential Listeria Monocytogenes Contamination

    FGF, LLC is recalling item 8201810 Fluff Bars distributed nationwide to the US and Canada due to potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    item 8201810 FLUFF BAR 78x2.75 OZ, NET WT 12.07 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0492-2025·2025-02-12

    FGF Frozen Bismark Donuts Recalled Due to Listeria Contamination Risk

    FGF, LLC is recalling frozen Bismark donuts due to potential Listeria monocytogenes contamination. The recall affects 2,017,614 cases distributed nationwide in the US and Canada.

    Product
    item 8201843 GEN BISMARK DONUT DGH FRZ 144x2OZ, NET WT 16.20 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0470-2025·2025-02-12

    Cake Donut Rings Recalled for Potential Listeria Contamination

    FGF, LLC is recalling cake donut rings due to potential contamination with Listeria monocytogenes. Distribution included nationwide US and Canada.

    Product
    item 8201779 GEN PLN CAKE DONUT RINGS PFD 90x2.5 OZ, NET WT 12.66LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0525-2025·2025-02-12

    Donuts Recalled for Potential Listeria Monocytogenes Contamination

    FGF LLC is recalling egg-shaped donuts nationwide due to potential Listeria monocytogenes contamination. Approximately 2,017,614 cases were distributed in the US and Canada.

    Product
    item 8201926 FBALL/EGG SHPD DONUT PFD 78 X 2OZ, NET WT 8.78 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2025·2025-02-12

    Surgical sutures recalled for potential sterility breach

    Ethicon is recalling ETHIBOND EXCEL Polyester Sutures due to open packaging seals that could compromise sterility and allow pathogen contamination. No illnesses have been reported.

    Product
    ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1094-2025·2025-02-12

    Philips Azurion and Allura Patient Table Finger Entrapment Risk

    Philips Azurion 7 M20 and Allura patient tables pose a finger entrapment risk during manual repositioning. Fingers can get caught between the tabletop and guiding rails, potentially causing finger injury to operators and service personnel.

    Product
    Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0509-2025·2025-02-12

    Pumpkin-shaped donuts recalled for potential Listeria contamination

    FGF, LLC is recalling pumpkin-shaped donuts distributed nationwide due to potential contamination with Listeria monocytogenes. Consumers should not consume the product.

    Product
    item 8201876 PMPKN SHAPE DONUT ZGT PFD 84x1.75OZ, NET WT 8.27 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0469-2025·2025-02-12

    Dierbergs Kitchen Mac & Cheese recalled for undeclared wheat allergen

    Dierbergs Markets recalls 298 packages of Mac & Cheese due to labeling errors that fail to disclose wheat allergens. The product was distributed to Missouri and Illinois retailers with a use-by date of 1/9/2025.

    Product
    Dierbergs Kitchen 16 oz Mac & Cheese packaged in a black plastic container with a clear plastic lid with a white label, The label states "Dierbergs Kitchen Homestyle Mashed Potatoes UPC 231220-006538"
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1103-2025·2025-02-12

    Nitrous Oxide Cartridges Recalled Due to Premature Valve Opening

    Integra Miltex CryoSolutions N2O cartridges are recalled because the valve may open prematurely, causing partial or complete cartridge emptying before use. Affected units were distributed nationwide and to Canada.

    Product
    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0214-2025·2025-02-12

    Timolol Maleate eye drops recalled for defective dropper cap

    FDC Limited is recalling Timolol Maleate ophthalmic solution because the dropper cap spike may become lodged in the bottle nozzle, preventing access to the medication. The recall affects one lot distributed to a single U.S. distributor in New Jersey.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0222-2025·2025-02-12

    Guaifenesin and Codeine Cough Syrup Recalled for Superpotent Strength

    PAI Pharmaceutical Associates is recalling Guaifenesin and Codeine Phosphate Oral Solution because the product contains higher-than-labeled active ingredient concentrations. The affected product was distributed in Ohio.

    Product
    GUAIFENESIN AND CODEINE PHOSPHATE — GUAIFENESIN AND CODEINE PHOSPHATE (GUAIFENESIN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1112-2025·2025-02-12

    Beckman Coulter Access PCT Reagent Pack Recalled for Calibration Failures

    Beckman Coulter Inc. is recalling specific lots of Access PCT Reagent Pack due to high rates of calibration failures that delay test result reporting on immunoassay systems used in healthcare and laboratory settings.

    Product
    Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1104-2025·2025-02-12

    Integra Miltex Cryosolutions Cartridges Recalled for Premature Valve Opening

    The Integra Miltex Cryosolutions Cartridges (Model C-CA-23) are being recalled because the valve may open prematurely during assembly, causing the cartridge to empty before use. Approximately 3,352 units were distributed nationwide in the US and Canada.

    Product
    Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V075000·2025-02-10

    Winnebago LP tank mounting fasteners may be improperly tightened

    Winnebago is recalling certain 2025 recreational vehicles because the LP tank mounting bracket fasteners may have been improperly tightened, causing the tank to detach.

    Product
    WINNEBAGO — WINNEBAGO NAVION, MINNIE WINNIE, VITA, VIEW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V050000·2025-02-07

    Mercedes-Benz 2024 EQB 250 Electric Vehicle Battery Fire Risk

    Mercedes-Benz is recalling certain 2022–2025 EQB 250, EQB 300 4MATIC, and EQB 350 4MATIC models due to a high-voltage battery that may fail internally and cause vehicle fire while parked or driving.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ EQB 350 4MATIC, EQB 250+, EQB 250, EQB 300 4MATIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V070000·2025-02-07

    Storyteller Overland Recalls MODE XO Vehicles Due to Seat Mounting Defect

    Storyteller Overland is recalling 2024-2025 MODE XO vehicles because improperly welded seat floor mounting systems may loosen or detach, increasing injury risk.

    Product
    STORYTELLER OVERLAND — STORYTELLER OVERLAND MODE XO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V071000·2025-02-07

    2025 Volvo EX90 Headlight Shutter Software Defect Recall

    Volvo is recalling 2025 EX90 vehicles because a software error in the low power controller may cause headlight shutters to close while driving, reducing visibility and increasing crash risk.

    Product
    VOLVO — VOLVO EX90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V074000·2025-02-07

    2022–2025 Husqvarna and GASGAS motorcycles recalled for brake caliper cracking

    KTM North America is recalling 2022–2025 Husqvarna FE 350S and FE 501S motorcycles, along with 2024–2025 GASGAS ES 350 and ES 500 models, due to front brake calipers that may crack and cause loss of front brake function.

    Product
    HUSQVARNA — HUSQVARNA, GASGAS FE 350S, ES 500, ES 350, FE 501S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V073000·2025-02-07

    Nikola TRE FCEV Hydrogen Tank Mounting Bolts May Cause Fuel Leak

    Nikola is recalling certain 2024–2025 TRE FCEV trucks because hydrogen tank mounting block bolts may be too long and damage the tank, creating a fire risk.

    Product
    NIKOLA — NIKOLA TRE FCEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V072000·2025-02-07

    Entegra and Jayco Recreational Vehicles Fuel Tank Support Bracket Fire Risk

    Jayco, Inc. is recalling certain 2021–2025 Entegra Launch and Jayco Terrain recreational vehicles. Grey water tank support brackets may contact and damage the fuel tank, causing a leak and fire risk.

    Product
    ENTEGRA — ENTEGRA, JAYCO LAUNCH, TERRAIN, TERRAIN LE, LAUNCH LE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V067000·2025-02-07

    Zeekr Recalls One 2025 RT Vehicle for Air Bag Software Defect

    Zeekr is recalling one 2025 RT vehicle because the occupant weight sensor software may misclassify passengers or disable the air bag, increasing crash injury risk.

    Product
    ZEEKR — ZEEKR RT (OJAI)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V061000·2025-02-07

    Grand Design Solitude Fifth Wheel Trailers Step Tread Defect Recall

    Grand Design is recalling certain 2019–2024 Solitude fifth wheel trailers because the step tread joints may be unsupported, causing the tread to break and increasing the risk of injury.

    Product
    GRAND DESIGN — GRAND DESIGN SOLITUDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V069000·2025-02-07

    2024–2025 Forest River Rockport work trucks E-Track system fastener failure recall

    Forest River is recalling certain 2024–2025 Rockport work trucks because incorrect fasteners may have been used to install the optional E-Track Cargo Tie Down system. The fasteners can fail, causing the system to detach from the wall and increase the risk of injury.

    Product
    FOREST RIVER — FOREST RIVER ROCKPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V068000·2025-02-07

    Zeekr Recalls One 2025 RT Vehicle for Air Bag Protection Defect

    Zeekr is recalling one 2025 RT vehicle because the seat position may prevent side curtain and passenger air bags from providing adequate neck protection during a crash.

    Product
    ZEEKR — ZEEKR RT (OJAI)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V066000·2025-02-07

    Zeekr Recalls One 2025 RT Vehicle for Air Bag Deployment Issue

    Zeekr is recalling one 2025 RT vehicle because the C-Pillar trim may prevent the side curtain air bag from fully deploying, increasing injury risk.

    Product
    ZEEKR — ZEEKR RT (OJAI)
    Category
    Vehicle
    Distribution
    Distributed nationwide

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