The Recall Desk

Archive

July 2025 recalls

632 recalls were announced in July 2025.

What the numbers show

Critical
4
Severe
232
High
244
Moderate
144
Low
8

Of the 632 recalls this month scored against our rubric, 1% are Critical, 37% are Severe.

401–500 of 632

  • SevereFDA (Food)·H-0183-2025·2025-07-09

    Zenshi salmon and cucumber sashimi sampler used recalled cucumbers

    Zenshi Handcrafted Sushi Sashimi Sampler with salmon and cucumber is being recalled over cucumbers recalled for possible Salmonella. 70 trays are affected.

    Product
    ZENSHI HANDCRAFTED SUSHI Sashimi Sampler - Salmon w/Cucumber 6pc Net Wt. 4.5oz UPC 0 23012 94305 9
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0155-2025·2025-07-09

    Zenshi salmon avocado and rainbow duo combo used recalled cucumbers

    Zenshi Handcrafted Sushi Duo Combo with Salmon Avocado and Rainbow Roll is being recalled over cucumbers recalled for possible Salmonella. 6,499 trays are affected.

    Product
    ZENSHI HANDCRAFTED SUSHI Duo Combo - Salmon Avocado & Rainbow Roll 10pc Net Wt 7.9oz UPC 0 23012 94207 6
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2041-2025·2025-07-09

    HardyCHROM CRE Culture Medium Recalled for Quality Control Failure

    Hardy Diagnostics is recalling HardyCHROM CRE culture medium (Catalog No. G323) distributed across 22 US states and Puerto Rico. The product failed quality control testing due to breakthrough growth of Klebsiella pneumoniae.

    Product
    HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
    Category
    Medical Device
    Distribution
    22 states
  • SevereFDA (Food)·H-0207-2025·2025-07-09

    Fruit and Vegetable Trays Recalled for Potential Salmonella Contamination

    JFE Franchising Inc. is recalling multiple fruit and vegetable tray products because cucumbers may be contaminated with Salmonella. The affected products were distributed in seven states with a sell-by date of May 20, 2025.

    Product
    Fruit & Vegetable Tray - 64 oz 63912394047 Mixed Melon, Cucumbers & Tajin - 18oz 63912394007 Watermelon & Cucumber w/ Tajin - 18oz 63912394036 Small Vegetable Tray - 19.5 oz 63912388045 Small Party Tray with Dip - 19 oz 63912388046 Large Vegetable Tray - 42 oz 63912
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·H-0145-2025·2025-07-09

    Zenshi crunchy shrimp roll trays made with recalled cucumbers

    Zenshi Handcrafted Sushi Crunchy Roll with shrimp is being recalled over cucumbers recalled for possible Salmonella. 6,523 trays are affected.

    Product
    ZENSHI HANDCRAFTED SUSHI Crunchy Roll - Shrimp 10pc Net Wt 10.0oz UPC 0 23012 95042 2
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0185-2025·2025-07-09

    Zenshi spicy California brown rice rolls made with recalled cucumbers

    Zenshi Handcrafted Sushi Spicy California Roll on brown rice is being recalled over cucumbers recalled for possible Salmonella. 4,906 trays are affected.

    Product
    ZENSHI HANDCRAFTED SUSHI Spicy California Roll 10pc (Brown Rice) Net Wt. 7.4oz UPC 0 23012 94405 6 & UPC 0 23012 95145 0
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0127-2025·2025-07-09

    Harris Teeter ZENSHI Handcrafted Sushi Chef Sampler recalled for Salmonella

    Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Chef Sampler A#4 (15pc, 14.6oz) because the cucumbers used in the product were recalled due to possible Salmonella contamination.

    Product
    ZENSHI HANDCRAFTED SUSHI Chef Sampler A#4 (Chili, Rainbow, Crunchy Dragon) 15pc Net Wt. 14.6oz (414g) UPC 0 23012 94332 5
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0139-2025·2025-07-09

    Harris Teeter ZENSHI Handcrafted Sushi Crunchy CA Roll Salmonella Recall

    Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Crunchy CA Roll (Brown Rice) due to possible Salmonella contamination from recalled cucumbers used in the product.

    Product
    ZENSHI HANDCRAFTED SUSHI Crunchy CA Roll 10pc (Brown Rice) Net Wt 8.1oz UPC 0 23012 94284 7 & UPC 0 23012 95143 6
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0198-2025·2025-07-09

    Harris Teeter ZENSHI HANDCRAFTED SUSHI Vegetable Roll recalled for Salmonella

    Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Vegetable Roll 10pc trays due to possible Salmonella contamination from recalled cucumbers used in the product.

    Product
    ZENSHI HANDCRAFTED SUSHI Vegetable Roll 10pc Net Wt. 7.1oz UPC 0 23012 94327 1 & UPC 0 23012 95151 1
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0197-2025·2025-07-09

    Zenshi ultimate chili tuna roll trays made with recalled cucumbers

    Zenshi Handcrafted Sushi Ultimate Chili Roll with tuna is being recalled over cucumbers recalled for possible Salmonella. 1,365 trays are affected.

    Product
    ZENSHI HANDCRAFTED SUSHI Ultimate Chili Roll - Tuna 10pc Net Wt. 10.4oz UPC 0 23012 94413 1
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0187-2025·2025-07-09

    ZENSHI Handcrafted Sushi Spicy Roll Salmon recalled for Salmonella

    Harris Teeter is recalling ZENSHI Handcrafted Sushi Spicy Roll - Salmon 10pc due to possible Salmonella contamination from recalled cucumbers used in the product.

    Product
    ZENSHI HANDCRAFTED SUSHI Spicy Roll - Salmon 10pc Net Wt. 7.1oz UPC 0 23012 94312 7 & 0 23012 95148 1
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2014-2025·2025-07-09

    Servo-n ventilators may measure patient circuit compliance inaccurately

    The Servo-n Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 7,688 units affected.

    Product
    Servo-n Ventilator System. Model Number: 6694800.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0190-2025·2025-07-09

    Harris Teeter ZENSHI Handcrafted Sushi Spicy Roll Shrimp Recall

    Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Spicy Roll - Shrimp 10pc (Brown Rice) due to possible Salmonella contamination from recalled cucumbers used in the product.

    Product
    ZENSHI HANDCRAFTED SUSHI Spicy Roll - Shrimp 10pc (Brown Rice) Net Wt. 7.1oz UPC 0 23012 94317 2
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0156-2025·2025-07-09

    Harris Teeter ZENSHI Handcrafted Sushi Duo Combo Recalled for Salmonella

    Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Duo Combo (Spicy Tuna & CA Salad Roll) due to possible Salmonella contamination from recalled cucumbers used in the product.

    Product
    ZENSHI HANDCRAFTED SUSHI Duo Combo - Spicy Tuna & CA Salad Roll 10pc Net Wt 7.1oz UPC 0 23012 94211 3
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0159-2025·2025-07-09

    ZENSHI Handcrafted Sushi Field Goal Platter Recalled for Salmonella Risk

    Harris Teeter is recalling ZENSHI Handcrafted Sushi Field Goal Platter because cucumbers used to make the sushi were recalled due to possible Salmonella contamination.

    Product
    ZENSHI HANDCRAFTED SUSHI Field Goal Platter 21pc Net Wt 19.3oz UPC 0 23012 93865 9
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0151-2025·2025-07-09

    Harris Teeter Zenshi Handcrafted Sushi Duo Combo Salmonella Recall

    Harris Teeter is recalling Zenshi Handcrafted Sushi Duo Combo due to possible Salmonella contamination from recalled cucumbers used in the product.

    Product
    ZENSHI HANDCRAFTED SUSHI Duo Combo - CA Salad & Salmon Avocado Roll 10pc Net Wt 7.0oz UPC 0 23012 94209 0
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0162-2025·2025-07-09

    ZENSHI HANDCRAFTED SUSHI Happy Heart Platter recalled for possible Salmonella

    Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Happy Heart Platter #1 (Rainbow Dragon Seaside) due to possible Salmonella contamination from recalled cucumbers used in the product.

    Product
    ZENSHI HANDCRAFTED SUSHI Happy Heart Platter #1 (Rainbow Dragon Seaside) 23pc Net Wt. 19.2oz UPC 0 23012 94360 8
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0186-2025·2025-07-09

    ZENSHI Handcrafted Sushi Spicy Grilled Salmon Roll recalled for Salmonella

    Harris Teeter is recalling ZENSHI Handcrafted Sushi Spicy Grilled Salmon Roll (10pc, 9.1oz) due to possible Salmonella contamination from recalled cucumbers used in the product.

    Product
    ZENSHI HANDCRAFTED SUSHI Spicy Grilled Salmon Roll 10pc Net Wt. 9.1oz UPC 0 23012 94243 4
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0178-2025·2025-07-09

    Harris Teeter ZENSHI Handcrafted Sushi Sampler Salmonella Recall

    Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Premium Chef Sampler #1 due to possible Salmonella contamination from recalled cucumbers used in the sushi.

    Product
    ZENSHI HANDCRAFTED SUSHI Premium Chef Sampler #1 (Rainbow, Salmon, Dragon, Dynamite) 20pc Net Wt. 19.9oz UPC 0 23012 94302 8
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0192-2025·2025-07-09

    Harris Teeter ZENSHI Handcrafted Sushi Spicy Roll Tuna Salmonella Recall

    Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Spicy Roll - Tuna 10pc (Brown Rice) due to possible Salmonella contamination from recalled cucumbers used in the product.

    Product
    ZENSHI HANDCRAFTED SUSHI Spicy Roll - Tuna 10pc (Brown Rice) Net Wt. 7.1oz UPC 0 23012 94319 6 & UPC 0 23012 95149 8
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0140-2025·2025-07-09

    Harris Teeter ZENSHI Handcrafted Sushi Crunchy Dragon Roll Recalled for Salmonella

    Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Crunchy Dragon Roll (10pc, 9.6oz) due to possible Salmonella contamination from recalled cucumbers used in the product.

    Product
    ZENSHI HANDCRAFTED SUSHI Crunchy Dragon Roll 10pc Net Wt. 9.6oz UPC 0 23012 94461 2
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2015-2025·2025-07-09

    Servo-u MR Ventilator System inaccurate patient circuit compliance measurement

    Servo-u MR Ventilator System (Model 6888800) may measure patient circuit compliance inaccurately due to incorrect pre-use leakage testing and incorrect active humidifier use.

    Product
    Servo-u MR Ventilator System. Model Number: 6888800.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0504-2025·2025-07-09

    Zicam cold remedy nasal swabs recalled over fungal contamination

    Zicam Cold Remedy Medicated Nasal Swabs are being recalled because of fungal contamination of the swabs. All lots are affected, covering 3,374,918 cartons.

    Product
    ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0201-2025·2025-07-09

    Zenshi yuzu teriyaki tuna roll trays made with recalled cucumbers

    Zenshi Handcrafted Sushi Yuzu Teriyaki Tuna Roll is being recalled because it was made with cucumbers recalled over possible Salmonella. 5,409 trays are affected.

    Product
    ZENSHI HANDCRAFTED SUSHI Yuzu Teriyaki Tuna Roll 10pc Net Wt. 3oz UPC 0 23012 95033 0
    Category
    Food
    Distribution
    8 states
  • HighNHTSA·25V461000·2025-07-09

    Prevost Recalls 2018-2019 X3-45 Commuters for Incorrect Window Glazing

    Prevost is recalling 2018-2019 X3-45 Commuter vehicles because incorrect entrance door window glazing may reduce driver visibility and increase crash risk.

    Product
    PREVOST — PREVOST X3-45 COMMUTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2025·2025-07-09

    Bard Urologist's Tray Recalled Over Incorrect French Size Labeling

    C.R. Bard Inc is recalling 63 units of the Bard Urologist's Tray due to cather packaging that may contain the incorrect French size, which could affect device use.

    Product
    REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2045-2025·2025-07-09

    Medline retinal packs recalled because catheter needle may fail to retract

    Medline RETINAL PACK-LF convenience kits are being recalled because the BD Insyte Autoguard catheter needle inside may be slow to retract or fail to retract during insertion. 80 units affected.

    Product
    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2025·2025-07-09

    Cardiology hemodynamics software update may cause unexpected system shutdowns

    Change Healthcare Cardiology Hemodynamics Software version 15.0.1 is being recalled because, following complaints, a software update may cause the software to unexpectedly shut down.

    Product
    Change Healthcare Cardiology Hemodynamics Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2079-2025·2025-07-09

    BD FACS 7-Color Setup Beads Recalled Due to Spectral Overlap Errors

    Becton, Dickinson and Company is recalling BD FACS 7-Color Setup Beads (REF 666289, Lots 85637 and 85638) because errors in the spectral overlap factors table may prevent accurate setup of flow cytometry instruments.

    Product
    REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Food)·H-0211-2025·2025-07-09

    Meijer dark chocolate almonds recalled for undeclared cashews in packaging

    Frederik's by Meijer Dark Chocolate Almonds are being recalled because of undeclared cashews. 3,301 cases are affected across six states.

    Product
    Frederik's by Meijer Dark Chocolate Almonds 12 oz. resealable bag, UPC 7 08820 68730 1, 6 retail units per wholesale case. Frederik's by Meijer Dark Chocolate Almond 12 oz. box of 8, 1.5 oz. individual serving pouches, UPC 7 19283 11923 0, 6 retail units per wholesale case.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2040-2025·2025-07-09

    VITROS 4600 chemistry systems may report results using expired diluent packs

    VITROS 4600 Chemistry Systems are being recalled because a software anomaly can allow results to be reported using diluent packs the system treats as expired, which can produce erroneous results.

    Product
    Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0212-2025·2025-07-09

    Vita Warehouse Vitamin B12 Gummies Recalled for Undeclared Peanut

    Vita Warehouse Corp. is recalling four Vitamin B12 gummy products nationwide due to undeclared peanut allergen. Consumers with peanut allergies should not use the affected products.

    Product
    1. Welby Vitamin B12 Adult Gummies 140 Count 2. Berkely Jensen¿ Vitamin B12 1000 mcg Gummies 250 count 3. VitaGlobe" Vitamin B12 Extra Strength Gummies 140 count 3. Vita Labs Vitamin B-12 Gummies Bulk 500 count
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0115-2025·2025-07-09

    Choco Mousse cups recalled for undeclared allergens

    Sabores Fit Bakery is recalling Choco Mousse cups because the label does not fully disclose allergens including milk, eggs, soy, wheat, tree nuts (almonds, hazelnuts).

    Product
    Choco Mousse, NET WT 8 OZ (230g), Sabores Bakery, Plastic Cups, 3.5-inch-wide x 3.75 in high, Keep refrigerated, PRODUCED EXCLUSIVELY BY: SABORES FIT BAKERY LLC. ORLANDO, FL 32836, UPC 7 35816 97176 2
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2069-2025·2025-07-09

    Apex Knee System components recalled over loss of sterile packaging integrity

    Apex Knee System components are being recalled because the age of the nylon packaging material has caused a loss of integrity of some pouches. 341 units are affected.

    Product
    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0117-2025·2025-07-09

    Three Milk Mousse cups recalled for undeclared allergens

    Sabores Fit Bakery is recalling Three Milk Mousse cups because the label fails to declare allergens including milk, eggs, soy, wheat, and tree nuts. Consumers with allergies to these ingredients should not consume the product.

    Product
    Three Milk Mousse, NET WT 8 OZ (230g), Sabores Bakery, Plastic Cups, 3.5-inch-wide x 3.75 in high, Keep refrigerated, PRODUCED EXCLUSIVELY BY: SABORES FIT BAKERY LLC. ORLANDO, FL 32836, UPC 7 35816 97176 2
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2044-2025·2025-07-09

    Medline IV Catheter Kits Recalled Over Needle Retraction Issue

    Medline is recalling 36 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN due to a potential needle retraction failure during insertion.

    Product
    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0500-2025·2025-07-09

    Compounded ketamine injection recalled over lack of sterility assurance concerns

    Ketamine Hydrochloride Injection compounded by Medivant Healthcare is being recalled for lack of assurance of sterility after an FDA inspection raised concerns about the sterile manufacturing process.

    Product
    KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2039-2025·2025-07-09

    VITROS XT 7600 Chemistry Analyzer Software Anomaly Causing Erroneous Test Results

    Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated System analyzers due to a software anomaly that can report test results as expired when reagent shelf expiration dates are omitted during manual loading, potentially causing erroneous or delayed test results.

    Product
    Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0203-2025·2025-07-09

    Peak Cocktails blood orange spritz cans may overpressurize and explode

    Peak Cocktails Blood Orange Spritz in 8.4 fl oz cans is being recalled because of overpressurization leading to exploding cans. 16,128 units are affected.

    Product
    Peak Cocktails Blood Orange Spritz 8.4 fl oz aluminum cans sold as an individual flavor and in variety packs of 12, 24, and 48 cans. Batch Codes: B25127, B25128; Packaging Date: 05/07/2025, 05/08/2025
    Category
    Food
    Distribution
    50 states
  • HighFDA (Food)·H-0119-2025·2025-07-09

    Strawberry Mousse Recalled for Undeclared Allergens

    Sabores Bakery is recalling Strawberry Mousse (8 oz plastic cups) because the label fails to declare milk, eggs, soy, wheat, and tree nuts (almonds, hazelnuts). Consumers with allergies to these ingredients should not consume the product.

    Product
    Strawberry Mousse, NET WT 8 OZ (230g), Sabores Bakery, Plastic Cups, 3.5-inch-wide x 3.75 in high, Keep refrigerated, PRODUCED EXCLUSIVELY BY: SABORES FIT BAKERY LLC. ORLANDO, FL 32836, UPC 7 35816 97176 2
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0498-2025·2025-07-09

    Compounded preservative-free lidocaine vials lack assurance of sterility

    Preservative-free Lidocaine HCl Injection 1%, compounded by Medivant Healthcare, is being recalled for lack of assurance of sterility. 29,700 vials are affected.

    Product
    LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 8522
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2025·2025-07-09

    ADVIA Hematology System Control Product Recall for Platelet Value Error

    Siemens Healthcare Diagnostics is recalling 3,266 units of ADVIA 120/2120/2120i 3-in-1 TESTpoint Control worldwide due to incorrect platelet value assignments that could affect test results.

    Product
    ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2058-2025·2025-07-09

    Philips S5-1 Ultrasound Transducers Refurbished Beyond Useful Life

    Philips Ultrasound is recalling Philips S5-1 Transducers because they were refurbished beyond their useful life, which may affect device performance and safety.

    Product
    Philips S5-1 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2025·2025-07-09

    Medline IV Catheters Recalled for Needle Retraction Failure

    Medline Industries is recalling specific Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters because the needle may be slow to retract or fail to retract during catheter insertion.

    Product
    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0116-2025·2025-07-09

    Passion Fruit Mousse Recalled for Undeclared Allergens

    Sabores Fit Bakery is recalling Passion Fruit Mousse (8 oz cups) because the label fails to declare milk, eggs, soy, wheat, and tree nuts allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Passion Fruit Mousse, NET WT 8 OZ (230g), Sabores Bakery, Plastic Cups, 3.5-inch-wide x 3.75 in high, Keep refrigerated, PRODUCED EXCLUSIVELY BY: SABORES FIT BAKERY LLC. ORLANDO, FL 32836, UPC 7 35816 97176 2
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0502-2025·2025-07-09

    Compounded lidocaine with epinephrine vials lack assurance of sterility

    Lidocaine HCl Sterile Injection 1% with epinephrine 1:100,000, compounded by Medivant Healthcare, is being recalled for lack of assurance of sterility. 2,825 vials affected.

    Product
    LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0144-2025·2025-07-09

    Harris Teeter Sushi Rolls Recalled Over Salmonella Risk

    Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Crunchy Roll - Salmon products due to possible Salmonella contamination from recalled cucumbers used in production.

    Product
    ZENSHI HANDCRAFTED SUSHI Crunchy Roll - Salmon 10pc Net Wt. 10.0oz UPC 0 23012 95040 8
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2020-2025·2025-07-09

    Siemens Interventional Fluoroscopic X-Ray System Software Communication Failure

    Siemens interventional fluoroscopic x-ray systems may fail to communicate dose information between sensor and software, causing incorrect high-dose reporting. The manufacturer is recalling affected units worldwide.

    Product
    interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2074-2025·2025-07-09

    BD Heyman Follower Straight Tip catheters with incorrect French size packaging

    C.R. Bard Inc is recalling BD Heyman Follower Straight Tip catheters because packaging may contain an incorrect French size designation, which could lead to use of the wrong catheter size.

    Product
    BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0138-2025·2025-07-09

    Harris Teeter Sushi Rolls Recalled Over Salmonella Risk

    Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Crunchy CA Roll trays because the cucumbers used in the sushi may be contaminated with Salmonella.

    Product
    ZENSHI HANDCRAFTED SUSHI Crunchy CA Roll 10pc Net Wt 8.1oz UPC 0 23012 94283 0 & UPC 0 23012 95144 3
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2051-2025·2025-07-09

    Philips C9-5EC Ultrasound Transducer Devices Recalled

    Philips Ultrasound, Inc. is recalling Philips C9-5EC transducer devices that were refurbished beyond their useful life, which may affect device performance and safety.

    Product
    Philips C9-5EC Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0501-2025·2025-07-09

    Compounded ketamine multi-dose vials recalled over sterility assurance concerns

    Ketamine Hydrochloride Injection 500 mg/5 mL multi-dose vials compounded by Medivant Healthcare are being recalled for lack of assurance of sterility. 14,725 vials are affected.

    Product
    KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0130-2025·2025-07-09

    Harris Teeter Sushi Recall Over Possible Salmonella Contamination

    Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Chef Sampler B#2 (Dragon Salmon Cheese) due to possible Salmonella contamination from recalled cucumbers used in the sushi.

    Product
    ZENSHI HANDCRAFTED SUSHI Chef Sampler B#2 (Dragon Salmon Cheese) 15pc Net Wt. 11.9oz (337g) UPC 0 23012 94338 7
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2019-2025·2025-07-09

    ARTIS angiography systems may incorrectly report a high radiation dose

    ARTIS angiography systems are being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.

    Product
    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography,
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2071-2025·2025-07-09

    Change Healthcare Cardiology Hemo Software Unexpected Shutdown Risk

    Change Healthcare is recalling Cardiology Hemo Software (version 14.3.2 and 15.0.1) because a software update may cause the system to unexpectedly shut down. The recall affects 29 systems distributed across multiple US states and international locations.

    Product
    Change Healthcare Cardiology Hemo Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2075-2025·2025-07-09

    BD Heyman Coude Tip Catheters Recalled Over French Size Labeling Error

    C.R. Bard Inc is recalling certain BD Heyman Follower Coude Tip catheters because the packaging may display the incorrect French size, which could lead to use of the wrong size device.

    Product
    BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2038-2025·2025-07-09

    VITROS 5600 Integrated System software anomaly reported

    Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System due to a software anomaly that can report test results using expired reagents even when the use-expired-reagents setting is disabled, potentially causing erroneous or delayed test results.

    Product
    Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2077-2025·2025-07-09

    ColoSense Test Kit Components Recalled for Control Failures

    Geneoscopy, Inc. is recalling ColoSense Test Kit Part No. 80-001 (Lot 80-001-A2501) due to multiple plate failures caused by Low Positive Template Control being too high and out of range.

    Product
    ColoSense Test Kit, Part No. 80-001, component of ColoSense test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2070-2025·2025-07-09

    HemoCue glucose microcuvettes experienced transit time outside of specified limits

    Four boxes of HemoCue Glucose 201 Microcuvettes are being recalled because transit time fell outside limits, so stability through the microcuvette lifetime can no longer be guaranteed.

    Product
    The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2087-2025·2025-07-09

    ADVIA hematology control lots carry incorrect platelet value assignments

    ADVIA 120/2120/2120i 3-in-1 TESTpoint Control lots are being recalled because they have the incorrect platelet value assignments for ADVIA hematology systems. 4,214 units affected.

    Product
    ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2022-2025·2025-07-09

    Fluoroscopic x-ray system recalled over dose sensor communication failure

    An interventional fluoroscopic x-ray system is being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.

    Product
    interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2056-2025·2025-07-09

    Philips L8-4 Ultrasound Transducers Recalled for Refurbishment Beyond Useful Life

    Philips Ultrasound is recalling 5,230 L8-4 transducer units that were refurbished beyond their useful life, which may affect device safety and performance. The units were distributed nationwide and internationally.

    Product
    Philips L8-4 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2021-2025·2025-07-09

    Interventional fluoroscopic x-ray systems may incorrectly report a high dose

    An interventional fluoroscopic x-ray system is being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.

    Product
    interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2073-2025·2025-07-09

    VITROS opiate reagent lots may give low quality control results

    VITROS Chemistry Products OP Reagent Gen 15 lots are being recalled because they may generate lower than expected quality control results. 2,017 units are affected.

    Product
    VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2050-2025·2025-07-09

    Philips C5-2 Ultrasound Transducers Refurbished Beyond Useful Life

    Philips Ultrasound, Inc. is recalling Philips C5-2 Transducers because they were refurbished beyond their useful life. The affected devices were distributed domestically nationwide and internationally across 49 countries.

    Product
    Philips C5-2 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2025·2025-07-09

    ADVIA Hematology Control Recalled for Incorrect Platelet Value Assignments

    Siemens Healthcare Diagnostics is recalling ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) units because they have incorrect platelet value assignments for the hematology systems.

    Product
    ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2068-2025·2025-07-09

    Philips XL14-3 Ultrasound Transducer Refurbished Beyond Useful Life

    Philips Ultrasound, Inc. is recalling Philips XL14-3 Transducers because they were refurbished beyond their useful life, which may affect device performance and patient safety during ultrasound examinations.

    Product
    Philips XL14-3 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2055-2025·2025-07-09

    Philips L12-4 Ultrasound Transducers Refurbished Beyond Useful Life

    Philips Ultrasound, Inc. is recalling 5,230 Philips L12-4 ultrasound transducer devices that were refurbished beyond their useful life. Affected units were distributed domestically and to numerous countries worldwide.

    Product
    Philips L12-4 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0507-2025·2025-07-09

    Gabapentin Capsules 100 mg recalled for defective blister packaging

    The Harvard Drug Group LLC is recalling 23,232 cartons of Gabapentin Capsules 100 mg (Lot# M05205, Exp Date 10/2026) distributed nationwide due to inadequately sealed blister packaging that may compromise product integrity.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2025·2025-07-09

    ADVIA hematology calibrator lots carry incorrect platelet value assignments

    ADVIA 120/2120/2120i SETpoint Calibrator lots are being recalled because they have the incorrect platelet value assignments for ADVIA hematology systems. 2,020 units are affected.

    Product
    ADVIA¿ 120/2120/2120i SETpoint Calibrator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2042-2025·2025-07-09

    My3D Personalized Solutions Humeral Cup lacks required inspections

    Onkos Surgical is recalling the My3D Personalized Solutions Humeral Cup, Model C24-0223-0003, because required inspections were not performed on finished product prior to release and distribution.

    Product
    My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2052-2025·2025-07-09

    Philips eL18-4 Ultrasound Transducers Recalled for Defective Refurbishment

    Philips Ultrasound is recalling Philips eL18-4 Transducers because they were refurbished beyond their useful life, which may affect device performance and patient safety.

    Product
    Philips eL18-4 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2078-2025·2025-07-09

    BD FACS setup beads have errors in spectral overlap factors table

    BD FACS 7-Color Setup Beads are being recalled because errors in the spectral overlap factors table may affect accurate setup of the flow cytometry instrument. 590 units affected.

    Product
    REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
    Category
    Medical Device
    Distribution
    37 states
  • ModerateFDA (Devices)·Z-2059-2025·2025-07-09

    Philips S7-2 Transducer Ultrasound Devices Recalled for Refurbishment

    Philips Ultrasound, Inc. is recalling Philips S7-2 Transducer ultrasound devices that were refurbished beyond their useful life. The affected devices have been distributed domestically and internationally.

    Product
    Philips S7-2 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0529-2025·2025-07-09

    Pitavastatin Tablets Recalled for Failed Impurity and Degradation Specifications

    AvKARE is recalling Pitavastatin 2 mg tablets nationwide due to failed impurity and degradation specifications. The affected lots do not meet quality standards for chemical purity.

    Product
    PITAVASTATIN — PITAVASTATIN (PITAVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2046-2025·2025-07-09

    Valeda light therapy devices shipped with European Union electrical configuration

    Eight Valeda Light Delivery Systems are being recalled because US customers were shipped devices configured for the European Union that could not be plugged into the outlet.

    Product
    Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V456000·2025-07-08

    Motiv Recalls 2021-2024 F-59 BEV Chassis Due to Battery Seal Defect

    Motiv Power Systems is recalling 2021-2024 F-59 BEV chassis vehicles because improperly sealed high-voltage battery packs may allow liquid entry, increasing the risk of fire or shock.

    Product
    MOTIV — MOTIV F-59 BEV CHASSIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25E039000·2025-07-07

    Ford Recalls 1.5L EcoBoost Cylinder Heads and Long Block Engines

    Ford is recalling certain 1.5L EcoBoost cylinder heads and long block engines sold as replacement parts because improper manufacturing may cause oil leaks, increasing the risk of fire or loss of drive power.

    Product
    ENGINE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V411000·2025-07-07

    Reading Truck Equipment Recalls 2021 Rail Gear HD Trucks for Weld Defects

    Reading Truck Group is recalling 2021 Rail Gear HD trucks because welds may crack, causing the front rail gear to shift and drag on the road, increasing crash risk.

    Product
    READING TRUCK EQUIPMENT — READING TRUCK EQUIPMENT RAIL GEAR TRUCKS HD
    Category
    Vehicle
    Distribution
    Distributed nationwide

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