The Recall Desk

Archive

January 2025 recalls

559 recalls were announced in January 2025.

What the numbers show

Critical
13
Severe
104
High
395
Moderate
44
Low
3

Of the 559 recalls this month scored against our rubric, 2% are Critical, 19% are Severe.

401–500 of 559

  • HighFDA (Food)·F-0353-2025·2025-01-08

    Gracie's Kitchen Cauliflower Florets Recalled Due to Listeria Risk

    Gracie's Kitchens Inc. is recalling Gracie's Kitchen brand Cauliflower Florets due to potential Listeria monocytogenes contamination. Affected product has sell-by dates from November 14-24, 2024, and was distributed in Connecticut and New York.

    Product
    a.) Gracie's Kitchen brand Cauliflower Florets; UPC: 85316-10012; 12 oz foam tray
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0329-2025·2025-01-08

    Diced White Onions Recalled for Potential Listeria Contamination

    Gracie's Kitchens Inc. is recalling diced white onion products due to potential Listeria monocytogenes contamination. Multiple brands (King Kullen, Wild By Nature, Gracie's Kitchen) are affected; products were distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Diced White Onion; UPC: 85316-10083; 12 oz plastic container b.) Wild By Nature brand Diced White Onion; UPC: 85316-10085; 12 oz plastic container c.) Gracie's Kitchen brand Diced White Onion; UPC: 85316-10018; 10 oz plastic container d.) Gracie's Kitchen br
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0167-2025·2025-01-08

    Levothyroxine Sodium tablets recalled for impurity specification failure

    Lupin Pharmaceuticals is recalling Levothyroxine Sodium 75 mcg tablets due to out-of-specification impurities detected in stability testing. Affected lot LA01276 (expiring 07/2026) was distributed to one Ohio distributor.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0323-2025·2025-01-08

    Multiple watermelon brands recalled due to Listeria contamination risk

    Gracie's Kitchens Inc. is recalling watermelon products from multiple brands due to potential Listeria monocytogenes contamination. Affected products were sold in Connecticut and New York with sell-by dates from November 9-21, 2024.

    Product
    a.) King Kullen brand Watermelon Slices; UPC 85316-10006; 20 oz foam tray b) Wild By Nature brand Watermelon Slices; UPC: 85316-10006; 20 oz foam tray c.) King Kullen brand Watermelon Chunks; UPC: 85316-10413; 12 oz plastic container d.) King Kullen brand Watermelon Slices; UPC:
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0346-2025·2025-01-08

    Fruit Platters Recalled Due to Potential Listeria Contamination

    Fruit Platters sold under King Kullen and Gracie's Kitchen brands may contain Listeria monocytogenes. Consumers in Connecticut and New York who purchased products with November 11-21, 2024 sell-by dates should not eat them.

    Product
    a.) King Kullen brand Large Fruit Platter; UPC: 85316-10402; 56 oz plastic container b.) Gracie's Kitchen brand Large Fruit Platter; UPC: 85316-10402; 56 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0326-2025·2025-01-08

    Honeydew Slices and Chunks Recalled for Listeria Contamination Risk

    Honeydew slices and chunks sold under King Kullen, Wild By Nature, and Gracie's Kitchen brands may be contaminated with Listeria monocytogenes. Affected products were distributed in Connecticut and New York with sell-by dates from November 9-21, 2024.

    Product
    a.) King Kullen brand Honeydew Slices; UPC 85316-10009; 20 oz foam tray b) Wild By Nature brand Honeydew Slices; UPC: 85316-10009; 20 oz foam tray c.) King Kullen brand Honeydew Chunks; UPC: 85316-10382; 16 oz plastic container d.) King Kullen brand Honeydew Chunks; UPC: 85316-10
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0781-2025·2025-01-08

    Medline Nasal Pack Procedure Kits Recalled for Potential Endotoxin Contamination

    Medline custom nasal pack procedure kits contain non-sterile surgical components with potential endotoxin contamination. Customers should discontinue use and contact Medline.

    Product
    Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0345-2025·2025-01-08

    Fruit Trays Recalled Due to Potential Listeria Contamination

    Multiple brands of fruit trays sold in Connecticut and New York are being recalled due to potential Listeria monocytogenes contamination. Consumers should not eat the affected products.

    Product
    a.) King Kullen brand Fruit Tray; UPC: 85316-10398; 42 oz plastic container b.) King Kullen brand Fruit Tray; UPC: 85316-10399; 1.65 plastic container c.) WIld by Nature Fruit Tray; UPC: 85316-10398; 42 oz plastic container d.) Wild by Nature Fruit Tray: UPC: 85316-10399; 1.65lb
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0787-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled Due to Sterility Concerns

    Medline is recalling custom surgical procedure kits that contain non-sterile surgical supplies with potential for endotoxin contamination. The kits were distributed worldwide, including the United States, United Arab Emirates, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF DYNJ80200B.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0331-2025·2025-01-08

    Peppers & Onions Products Recalled for Listeria Contamination Risk

    Multiple brands of peppers & onions products are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Peppers & Onions; UPC: 85316-10087; 12 oz plastic container b.) Wild by Nature brand Peppers & Onions; UPC: 85316-10087; 12 oz plastic container c.) Gracie's Kitchen brand Peppers & Onions; UPC: 85316-10001; 12 oz plastic container d.) Gracie's Kitchen brand
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0340-2025·2025-01-08

    Gracie's Kitchens Mango Berry Products Recalled for Listeria Risk

    Mango Berry smoothies sold under King Kullen, Wild By Nature, and Gracie's Kitchen brands may be contaminated with Listeria monocytogenes. Affected products have Sell By dates between 11/11/24 and 11/21/24.

    Product
    a.) King Kullen brand Mango Berry; UPC: 85316-10378; 12 oz plastic container b.) Wild By Nature brand Mango Berry; UPC: 85316-10378; 12 oz plastic container c.) Gracie's Kitchen brand Mango Berry; UPC: 85316-10325; 12 oz plastic container d.) Gracie's Kitchen brand Mango Berry Cu
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0776-2025·2025-01-08

    Baxter Infusion Pump Recalled for Incomplete Post-Repair Testing

    Baxter Healthcare is recalling certain infusion pumps that were released after repair without complete testing. Incomplete testing could affect how the device delivers medication to patients.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0339-2025·2025-01-08

    Mango Products Recalled for Potential Listeria Contamination

    Multiple mango brands sold in Connecticut and New York are being recalled due to potential Listeria monocytogenes contamination. Consumers should discard affected products or return them to retailers.

    Product
    a.) King Kullen brand Mango; UPC: 85316-10377; 12 oz plastic container b.) King Kullen brand Mango Spears; UPC: 85316-10387; 16 oz plastic container c.) Wild by Nature brand Mango; UPC: 85316-10377; 12 oz plastic container d.) Gracie's Kitchen brand Mango Spears; UPC: 85316-10337
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0355-2025·2025-01-08

    Gracie's Kitchen Mango & Blueberry Cup Recalled for Possible Listeria Contamination

    Gracie's Kitchen brand Mango & Blueberry Cup may be contaminated with Listeria monocytogenes. The recall affects 3,681 cases distributed in Connecticut and New York.

    Product
    a.) Gracie's Kitchen brand Mango & Blueberry Cup; UPC: 85316-10347; 12 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0350-2025·2025-01-08

    Fruit Spears from Multiple Brands Recalled for Listeria Contamination

    Gracie's Kitchens Inc. is recalling Wild by Nature and Gracie's Kitchen brand Fruit Spears due to potential Listeria monocytogenes contamination. Affected products were distributed in Connecticut and New York with sell-by dates from November 11 to November 21, 2024.

    Product
    a.) Wild by Nature brand Fruit Spears; UPC: 85316-10393; 24 oz plastic container b.) Gracie's Kitchen brand Fruit Spears; UPC: 85316-10393; 24 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0775-2025·2025-01-08

    Baxter SIGMA Spectrum Infusion Pump Recalled for Incomplete Post-Repair Testing

    Baxter is recalling SIGMA Spectrum Infusion Pump (Version 6) units that were released after repair without complete flow testing. The incomplete testing poses a risk of improper device operation.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0368-2025·2025-01-08

    Garden Salad with Dressing Recalled Due to Potential Salmonella Contamination

    Russ Davis Wholesale is recalling garden salads sold under Crazy Fresh and quick & easy brands due to potential Salmonella contamination in cucumbers. Affected products have sell-by dates of November 6-16, 2024.

    Product
    Garden Salad w/Ranch Dressing, Net Wt 9oz. Keep Refrigerated. UPC 7 95831-81023 3. Containing Lettuce, tomatoes, cucumbers, cheddar cheese, carrots and hard cooked egg. Sold under the following brands: 1. Crazy Fresh 2. quick & easy, Ready to Enjoy
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0322-2025·2025-01-08

    King Kullen and Wild by Nature vegetable platters recalled for Listeria

    Gracie's Kitchens Inc. is recalling King Kullen and Wild by Nature brand vegetable platters (44 oz) distributed in Connecticut and New York due to potential Listeria monocytogenes contamination. Affected products have sell-by dates from November 14-24, 2024.

    Product
    a.) King Kullen brand Vegetable Platter; UPC 85316-10005; 44oz plastic container b.) Wild by Nature brand Vegetable Platter; UPC 85316-10005; 44 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0327-2025·2025-01-08

    Stuffed Artichokes Recalled Due to Possible Listeria Contamination

    King Kullen and Gracie's Kitchen brand stuffed artichokes have been recalled because they may be contaminated with Listeria monocytogenes. Consumers should not eat these products.

    Product
    a.) King Kullen brand Stuffed Artichokes; UPC: 85316-10061; 16 oz foam tray b.) Gracie's Kitchen brand Stuffed Artichokes; UPC: 85316-10055; 16 oz foam tray
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0351-2025·2025-01-08

    Gracie's Kitchen Broccoli & Cauliflower Florets Recalled for Listeria

    Gracie's Kitchen brand Broccoli & Cauliflower Florets (12 oz foam trays) are being recalled due to potential Listeria monocytogenes contamination. The recalled products were distributed in Connecticut and New York.

    Product
    a.) Gracie's Kitchen brand Broccoli & Cauliflower Florets; UPC: 85316-1009; 12 oz foam tray
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0344-2025·2025-01-08

    Watermelon Halo Products Recalled for Potential Listeria Contamination

    King Kullen and Gracie's Kitchen brand Watermelon Halo products are being recalled due to potential Listeria monocytogenes contamination. The products were distributed in Connecticut and New York with sell-by dates from November 11 through November 21, 2024.

    Product
    a.) King Kullen brand Watermelon Halo; UPC: 85316-10392; 26 oz plastic container b.) Gracie's Kitchen brand Watermelon Halo; UPC: 85316-10392; 26 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0334-2025·2025-01-08

    King Kullen Tri Colored Noodles Recalled for Possible Listeria Contamination

    King Kullen brand Tri Colored Noodles may be contaminated with Listeria monocytogenes. The recall affects 3681 cases distributed in Connecticut and New York with sell-by dates from November 12–22, 2024.

    Product
    a.) King Kullen brand Tri Colored Noodles; UPC: 85316-10146; 14 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0779-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Non-Sterile Components

    Medline is recalling custom surgical procedure kits containing non-sterile surgical components with potential endotoxin contamination. The recall affects 1,402 units distributed in the US, Canada, and UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0338-2025·2025-01-08

    Mixed Fruit Products Recalled for Listeria Contamination Risk

    Gracie's Kitchens Inc. is recalling multiple brands of mixed fruit products due to potential Listeria monocytogenes contamination. Affected products were sold in Connecticut and New York with sell-by dates of November 11-21, 2024.

    Product
    a.) King Kullen brand Mixed Fruit; UPC: 85316-10376; 12 oz plastic container b.) King Kullen brand Mixed Fruit; UPC: 85316-10385; 16 oz plastic container c.) Wild By Nature brand Mixed Fruit; UPC: 85316-10376; 12 oz plastic container d.) Wild By Nature brand Mixed Fruit; UPC: 853
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0780-2025·2025-01-08

    Medline custom surgical procedure kits recalled for non-sterile components and endotoxin contamination

    Medline custom procedure kits containing non-sterile Codman Surgical Patties & Strips are being recalled due to potential endotoxin contamination. The recall affects 74 units distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2025·2025-01-08

    Medline custom surgical procedure kits recalled for non-sterile components

    Medline is recalling 182 custom surgical procedure kits containing non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. The kits were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR CERVICAL-CORPECTOMY, REF DYNJ904827.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0347-2025·2025-01-08

    King Kullen Papaya Chunks recalled for potential Listeria contamination

    King Kullen brand Papaya Chunks are being recalled due to potential Listeria monocytogenes contamination. Consumers should not consume the affected product.

    Product
    a.) King Kullen brand Papaya Chunks; UPC: 85316-10411; 12 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0348-2025·2025-01-08

    Wild by Nature Squash Noodles recalled for potential Listeria contamination

    Gracie's Kitchens Inc. is recalling Wild by Nature brand Squash Noodles due to potential Listeria monocytogenes contamination. The recalled product was distributed in Connecticut and New York.

    Product
    a.) WIld by Nature brand Squash Noodles; UPC: 85316-10022; 14 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0362-2025·2025-01-08

    Beef & Lamb Gyro Meal Kit Recalled for Salmonella Risk

    Reser's Fine Foods is recalling Beef & Lamb Gyro Sandwich Express Meal Kits due to potential Salmonella contamination in the tzatziki sauce. The recall affects 5,271 cases distributed across 19 states.

    Product
    Beef & Lamb Gyro Sandwich Express Meal Kit. Net wt. 31.8oz. UPC 0 13454 38313 1. Each kit contains 6 Pitas, Gyro Meat, Tzatziki Sauce 3oz. cups, Fire Feta Sauce, Feta Cheese Crumbles. Packaged in clear plastic clamshell. Distributed by Fresh Creative Foods, Vista CA.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0777-2025·2025-01-08

    Medline surgical procedure kits recalled for non-sterile supplies

    Medline is recalling custom medical procedure kits containing non-sterile surgical supplies with potential endotoxin contamination. The affected kits were distributed nationwide and internationally.

    Product
    Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0335-2025·2025-01-08

    Mirepoix Recall Due to Potential Listeria Contamination

    Gracie's Kitchens Inc. is recalling certain Mirepoix products sold under the King Kullen and Gracie's Kitchen brands due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Mirepoix; UPC: 85316-10167; 20 oz plastic container b.) Gracie's Kitchen brand Mirepoix; UPC: 85316-10167; 20 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0789-2025·2025-01-08

    Medline MICRODISECTOMY PACK recalled for endotoxin contamination

    Medline custom MICRODISECTOMY PACK kits containing non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination are being recalled. Approximately 1,494 units were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0797-2025·2025-01-08

    3M Unitek Orthodontic Primer Recalled Due to Bond Failures and Skin Irritation

    3M Unitek is recalling Transbond Plus Self-Etching Primer used in orthodontic bonding due to reports of bracket bond failures and skin irritation or blistering.

    Product
    3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2025·2025-01-08

    Medical Device Kits Recalled for Non-Sterile Surgical Components

    Medline Industries is recalling See DocMan custom convenience kits that contain non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. Approximately 48,655 units were distributed worldwide.

    Product
    See DocMan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2025·2025-01-08

    Medtronic SynchroMed II and III Implantable Pumps Recalled for Software Defects

    Medtronic is recalling SynchroMed II and III implantable pumps used with a clinician tablet app that has software issues in version 2.x. Approximately 319 systems were distributed worldwide.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2025·2025-01-08

    Rigid Intracardiac Sucker Units Recalled for Potential Sterility Breach

    Med Michigan Holding recalls SUC-4300S Rigid Intracardiac Suckers due to incomplete or partial pouch seals that may compromise sterility during cardiac surgery.

    Product
    SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0785-2025·2025-01-08

    Medline surgical procedure kits recalled for potential endotoxin contamination

    Medline is recalling three custom surgical procedure kits due to non-sterile Codman Surgical Patties and Strips that pose a potential endotoxin contamination risk. The affected kits were distributed in the US, Canada, and the UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF DYNJ40644A; 3) ENDO SINUS PACK, REF DYNJ66449.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0341-2025·2025-01-08

    Tropical Fruit Cup Products Recalled for Possible Listeria Contamination

    King Kullen and Gracie's Kitchen brand tropical fruit cups may contain Listeria monocytogenes. Affected products were distributed in Connecticut and New York with sell-by dates from 11/11 to 11/21/24.

    Product
    a.) King Kullen brand Tropical Fruit Cup; UPC: 85316-10384; 16 oz plastic container b.) King Kullen brand Tropical Fruit Cup; UPC: 85316-10403; 12 oz plastic container c.) Gracie's Kitchen brand Tropical Fruit Cup; UPC: 85316-10384; 16 oz plastic container d.) Gracie's Kitchen br
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0337-2025·2025-01-08

    Gracie's Kitchens Fiesta Bowl Salads Recalled for Listeria Contamination

    Gracie's Kitchens Inc. is recalling three brands of Fiesta Bowl salads (King Kullen, Wild By Nature, and Gracie's Kitchen) sold in Connecticut and New York due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Fiesta Bowl; UPC: 85316-10201; 64 oz plastic container b.) Wild By Nature brand Fiesta Bowl; UPC: 85316-10201; 64 oz plastic c.) Gracie's Kitchen brand Fiesta Bowl; UPC: 85316-10214; 60 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0336-2025·2025-01-08

    Watermelon Bowl Products Recalled for Potential Listeria Contamination

    Gracie's Kitchens Inc. is recalling King Kullen and Gracie's Kitchen branded Fiesta Watermelon Bowl products due to potential Listeria monocytogenes contamination. Affected products were distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Fiesta Watermelon Bowl; UPC: 85316-10200; 60 oz plastic container b.) Gracie's Kitchen brand Fiesta Watermelon Bowl; UPC: 85316-10202; 60 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0325-2025·2025-01-08

    Cantaloupe products recalled due to potential Listeria monocytogenes contamination

    Gracie's Kitchens Inc. is recalling cantaloupe slices and chunks sold under King Kullen, Wild By Nature, and Gracie's Kitchen brands due to potential Listeria monocytogenes contamination. Products were distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Cantaloupe Slices; UPC 85316-10008; 20 oz foam tray b) Wild By Nature brand Cantaloupe Slices; UPC: 85316-10008; 20 oz foam tray c.) King Kullen brand Cantaloupe Chunks; UPC: 85316-10379; 12 oz plastic container d.) King Kullen brand Cantaloupe Chunks; UPC:
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0354-2025·2025-01-08

    Gracie's Kitchen Diced Carrots recalled for potential Listeria monocytogenes contamination

    Gracie's Kitchen brand Diced Carrots may be contaminated with Listeria monocytogenes. The recall affects 3,681 cases distributed in Connecticut and New York with sell-by dates between November 12-22, 2024.

    Product
    a.) Gracie's Kitchen brand Diced Carrots; UPC: 85316-10019; 10 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0349-2025·2025-01-08

    Gracie's Kitchens and Wild by Nature Mixed Peppers Recalled for Listeria

    Gracie's Kitchens and Wild by Nature brand sliced and diced mixed peppers may be contaminated with Listeria monocytogenes. The recall affects products distributed in Connecticut and New York.

    Product
    a.) Wild by Nature brand Sliced Mixed Peppers; UPC: 85316-10102; 12 oz plastic container b.) Gracie's Kitchen brand Sliced Mixed Peppers; UPC: 85316-10007; 12 oz plastic container c.) Gracie's Kitchen brand Diced Tri Color Peppers; UPC: 85316-10023; 10 oz plastic container d.) Gr
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0332-2025·2025-01-08

    Fajita Mix Products Recalled for Potential Listeria Contamination

    Gracie's Kitchens Inc. is recalling King Kullen and Gracie's Kitchen brand Fajita Mix products distributed in Connecticut and New York due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Fajita Mix; UPC: 85316-11090; 12 oz plastic container b.) Gracie's Kitchen brand Fajita Mix; UPC: 85316-10002; 12 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0333-2025·2025-01-08

    Brussel Sprout Products Recalled for Potential Listeria Contamination

    Gracie's Kitchens Inc. is recalling brussel sprout products sold under King Kullen, Wild by Nature, and Gracie's Kitchen brands due to potential Listeria monocytogenes contamination. Affected products were distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Brussel Sprout Halves; UPC: 85316-10097; 12 oz plastic container b.) King Kullen brand Brussel Sprouts Shredded; UPC: 85316-10098; 12 oz plastic container c.) Wild by Nature brand Brussel Sprout Halves; UPC: 85316-10097; 12 oz plastic container d.) Gracie's
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0324-2025·2025-01-08

    Multiple pineapple products recalled for potential Listeria contamination

    Gracie's Kitchens Inc. is recalling pineapple products sold under King Kullen, Wild By Nature, and Gracie's Kitchen brands in Connecticut and New York due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Pineapple Slices; UPC 85316-10007; 20 oz foam tray b) Wild By Nature brand Pineapple Slices; UPC: 85316-10007; 20 oz foam tray c.) King Kullen brand Pineapple Chunks; UPC: 85316-10386; 16 oz plastic container d.) King Kullen brand Pineapple Spears; UPC: 8531
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0366-2025·2025-01-08

    Minnesota Milk Bank Donor Human Milk Recalled for Undetermined Foreign Material

    Minnesota Milk Bank for Babies is recalling 136 bottles of pasteurized donor human milk due to potential contamination with undetermined foreign material. The affected batch (002237-1) expires 01/01/2025.

    Product
    MN Milk Bank for Babies Pasteurize Donor Human Milk. Volume: 4 fl. oz. / 120 ml. Milk Type: 20 kcal/oz. 1.0 g/dL Total Protein. MN Milk Bank for Babies, Roseville, MN 55113
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0328-2025·2025-01-08

    Diced Celery Products Recalled Due to Potential Listeria Contamination

    Gracie's Kitchens Inc. is recalling multiple brands of diced celery sold in Connecticut and New York due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Diced Celery; UPC: 85316-10083; 12 oz plastic container b.) Wild By Nature brand Diced Celery; UPC: 85316-10083; 12 oz plastic container c.) Gracie's Kitchen brand Diced Celery: UPC: 85316-10020; 10 oz plastic container d.) Gracie's Kitchen brand Diced Celer
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0342-2025·2025-01-08

    Halo Bowl Recalled Due to Potential Listeria Monocytogenes Contamination

    Three brands of Halo Bowl (King Kullen, Wild by Nature, Gracie's Kitchen) are recalled for potential Listeria monocytogenes contamination. Affected products sold in CT and NY with Sell By dates 11/11–11/21/24.

    Product
    a.) King Kullen brand Halo Bowl; UPC: 85316-10390; 28 oz plastic container b.) Wild by Nature brand Halo Bowl; UPC: 85316-10390; 28 oz plastic container c.) Gracie's Kitchen brand Halo Bowl; UPC: 85316-10312; 28 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0320-2025·2025-01-08

    Chocolate Raspberry Bakery Products Recalled for Undeclared Allergens and Color Additives

    Lithuanian Bakery, Inc. is recalling Chocolate Raspberry baked goods in three sizes due to undeclared milk, soy, peanut, wheat, sulfites, and color dyes. Consumers with allergies should not consume these products.

    Product
    Chocolate Raspberry: Three sizes, 1. Small, Net Wt 1.25 lbs. (sub ingredients contain, yellow #5 and #6, and red #40 not declared on final product label) 2. Medium, Net Wt 2.75 lbs. (sub ingredients contain milk, yellow #5 and #6, and red #40 not declared on final product labe
    Category
    Food
    Distribution
    7 states
  • HighFDA (Drugs)·D-0172-2025·2025-01-08

    Dapsone Topical Gel Recalled Due to Crystallization Defect

    Viona Pharmaceuticals is recalling Dapsone Gel 7.5% (2760 packs) distributed nationwide due to crystallization in the formulation. The voluntary recall affects lots T400514 and T400808.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0174-2025·2025-01-08

    Injectable phenylephrine recalled due to defective tamper-evident seals nationwide

    Hikma Injectables is recalling phenylephrine injections nationwide because tamper-evident seals on some syringes were not properly attached. Affected lot 243120003D has a use-by date of 03/11/2025.

    Product
    phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0778-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Endotoxin Contamination Risk

    Medline Industries is recalling 2344 custom surgical kits with non-sterile components that may contain endotoxins. The kits were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2025·2025-01-08

    Medline Deep Brain Stimulation Surgical Kits Recalled for Non-Sterile Contamination

    Medline has recalled 128 Deep Brain Stimulation surgical kits for containing non-sterile Surgical Patties and Strips with potential endotoxin contamination. Affected units were distributed worldwide including the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2025·2025-01-08

    Medtronic Implantable Drug Pumps Recalled for Software Defects

    Medtronic has recalled 566 SynchroMed II and III implantable drug infusion pumps due to software issues in the controlling application. No injuries or illnesses have been reported.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2025·2025-01-08

    Surgical spears recalled for potential sterile barrier defect

    Carwild Corporation recalls 300 Ivalon cellulose surgical spears (Model Q604237) due to potential package seal defects that could compromise sterility during ophthalmic surgical procedures.

    Product
    Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0772-2025·2025-01-08

    SynchroMed II and III implantable pumps recalled for software issues

    Medtronic recalled SynchroMed II and III implantable pumps for software issues in the clinician tablet application. Fifty-nine systems are affected.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-01082025-01·2025-01-08

    Chicken Curry Empanadas Recalled For Undeclared Milk Allergen

    USDA FSIS issued a public health alert for Chicken Curry Empanadas that may contain undeclared milk. Consumers with milk allergies should not consume these products.

    Product
    Rajbhog Foods (NJ), Inc. — FSIS Issues Public Health Alert For Chicken Empanada Products Due To Misbranding And Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0343-2025·2025-01-08

    King Kullen and Gracie's Kitchen Tropical Delight Bowls recalled for potential Listeria contamination

    Gracie's Kitchens Inc. is recalling Tropical Delight Bowls distributed in Connecticut and New York due to potential Listeria monocytogenes contamination. Affected products have sell-by dates of November 11–21, 2024.

    Product
    a.) King Kullen brand Tropical Delight Bowl; UPC: 85316-10391; 28 oz plastic container b.) Gracie's Kitchen brand Tropical Delight Bowl; UPC: 85316-10313; 28 oz plastic container c.) Gracie's Kitchen brand Tropical Delight Bowl; UPC: 85316-10391; 28 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0173-2025·2025-01-08

    Ketamine injection syringes recalled due to missing tamper-evident seals

    Hikma Injectables is recalling 1,800 ketamine injection syringes nationwide because tamper-evident seals are not attached to several syringes, compromising sterility assurance.

    Product
    ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·25V004000·2025-01-08

    Blue Bird Recalls 2025 All American Bus for Wiring Defect

    Blue Bird is recalling one 2025 All American transit bus because incorrect wiring reverses high and low beams, potentially blinding other drivers.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V003000·2025-01-08

    Blue Bird Recalls 2024-2025 All American School Buses for Wiring Defect

    Blue Bird is recalling 2024-2025 All American school buses because incorrect wiring reverses high and low beams, potentially blinding other drivers.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0792-2025·2025-01-08

    Medline Medical Procedure Kits Recalled for Non-Sterile Component Contamination

    Medline Industries is recalling 2,664 custom medical procedure kits containing non-sterile surgical components with potential endotoxin contamination. The affected kits were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0786-2025·2025-01-08

    Medline Custom Surgical Kits Recalled for Non-Sterile Components with Endotoxin Risk

    Medline Industries is recalling 3,903 custom medical procedure kits due to non-sterile Codman Surgical Patties and Strips with potential for endotoxin contamination. The recall affects products distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE FLAP PACK-LF, REF DYNJ42833B; 4) TYMPANOPLASTY PACK, REF DYNJ50692C; 5) MAJOR CRANIOTOMY SAFETY, REF DYNJ54736B; 6) FREE FLAP CU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0798-2025·2025-01-08

    Ophthalmic Surgical Device Recalled for Potential Sterile Barrier Compromise

    Carwild Corporation is recalling Ivalon Eye Wick 20cm surgical devices due to package seals that are out of specification and cannot guarantee sterile barrier integrity for the life of the product.

    Product
    Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0783-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Non-Sterile Components

    Medline is recalling 943 custom surgical kits containing non-sterile Codman Surgical Patties and Strips that may be contaminated with endotoxin.

    Product
    Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2025·2025-01-08

    SynchroMed II and III Implantable Pumps Recalled for Software Issues

    Medtronic has recalled 3,981 SynchroMed implantable pumps worldwide due to software issues in application version 2.x used to program the devices.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0800-2025·2025-01-08

    Surgical Nasal Packing Devices Recalled for Sterile Barrier Defect

    Carwild is recalling Ivalon Anatomical Nasal Packing devices because the package seal may be defective, leaving the sterile barrier unable to be guaranteed. Lot 24F1638 with approximately 140 units was distributed across multiple U.S. states and internationally.

    Product
    Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-0352-2025·2025-01-08

    Gracie's Kitchen Broccoli Florets Recalled for Possible Listeria Contamination

    Gracie's Kitchen brand Broccoli Florets are being recalled due to possible contamination with Listeria monocytogenes. The recall affects 3,681 cases distributed in Connecticut and New York with sell-by dates between November 14-24, 2024.

    Product
    a.) Gracie's Kitchen brand Broccoli Florets; UPC: 85316-10011; 12 oz foam tray
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0784-2025·2025-01-08

    Medline Custom Surgical Procedure Kits Recalled for Potential Endotoxin Contamination

    Medline Industries is recalling custom medical procedure kits due to non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. Approximately 1,072 units were distributed in the US, Canada, and UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT ENDO SINUS WILMINGTON PACK, REF DYNJ66447; 4) ENDOSCOPIC SKULL BASE, REF DYNJ58648D; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648J.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·25088·2025-01-08

    Children's Bike Helmets Recalled for Failure to Meet Federal Safety Standards

    About 6,500 Wemfg children's bike helmets sold on Amazon fail to comply with federal safety standards for impact protection and stability. The helmets can fail to protect in crashes, posing a risk of head injury.

    Product
    Wemfg Children's Multi-Purpose Bike Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0330-2025·2025-01-08

    Gracie's Kitchens Diced Red Onion Recalled for Potential Listeria Contamination

    Diced red onion products from multiple brands manufactured by Gracie's Kitchens Inc. have been recalled due to potential Listeria monocytogenes contamination. The recall affects products distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Diced Red Onion; UPC: 85316-10086; 12 oz plastic container b.) Wild By Nature brand Diced Red Onion; UPC: 85316-10086; 12 oz plastic container c.) Gracie's Kitchen brand Diced Red Onion; UPC: 85316-10017; 10 oz plastic container d.) Gracie's Kitchen brand Di
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0171-2025·2025-01-08

    Dapsone Gel Recalled Nationwide for Crystallization

    Viona Pharmaceuticals is recalling Dapsone Gel 7.5% nationwide due to crystallization detected in multiple lots. Patients should contact their pharmacy or healthcare provider for guidance.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0176-2025·2025-01-08

    Eye drops recalled nationwide due to labeling mix-up

    AvKARE is recalling Polyvinyl Alcohol Ophthalmic Solution eye drops due to a labeling mix-up. The recall affects Lot #0160 and was distributed nationwide.

    Product
    POLYVINYL ALCOHOL — POLYVINYL ALCOHOL (POLYVINYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0168-2025·2025-01-08

    AvKARE Nitrofurantoin 100 mg Capsules Recalled for Dissolution Failures

    AvKARE is recalling Nitrofurantoin 100 mg capsules (NDC 50268-625-15, lot 47101, exp. 02/2026) nationwide because they failed dissolution specifications. Affected users should consult their healthcare provider.

    Product
    Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0175-2025·2025-01-08

    Carboxymethylcellulose sodium eye drops recalled for label mix-up

    AvKARE is recalling Carboxymethylcellulose Sodium Ophthalmic Solution eye drops due to a label mix-up. The recall affects 16,677 cartons distributed nationwide.

    Product
    CARBOXYMETHYLCELLULOSE SODIUM — CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0375-2025·2025-01-08

    Wegmans Jalapeno Baked Cheese Puffs Recalled for Undeclared MSG

    Herr Foods Inc is recalling Wegmans Jalapeno Baked Cheese Puffs due to undeclared monosodium glutamate and flavor compounds. Affected units have expiration dates from December 2024 through May 2025.

    Product
    Wegmans Jalapeno Baked Cheese Puffs, Jalapeno flavored, 10oz, (283 g), SKU #6877
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0770-2025·2025-01-08

    Auryon Laser Atherectomy System Recalled for Activation Failure

    Angiodynamics is recalling 138 units of the Auryon atherectomy laser system due to potential failure to advance to activation mode during use. This malfunction could cause procedural delays or interruptions.

    Product
    AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V002000·2025-01-06

    Tesla Model X, Model Y, Model S, and Model 3 Rearview Camera Loss

    Tesla is recalling certain 2023–2025 Model X, Model Y, Model S, and Model 3 vehicles because the computer circuit board may short, disabling the rearview camera image. This reduces rear visibility and increases crash risk.

    Product
    TESLA — TESLA MODEL Y, MODEL X, MODEL S, MODEL 3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-01052025-01·2025-01-05

    Frozen Raw Ground Beef Recalled for Foreign Matter Contamination

    USDA FSIS issued a public health alert for frozen raw ground beef from Stockyards Packing Co. due to possible hard plastic and metal contamination.

    Product
    Stockyards Packing Co LLC — FSIS Issues Public Health Alert for Frozen, Raw Ground Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·25V001000·2025-01-02

    Aston Martin Vehicles Recalled: Infotainment Display Obstructs Rearview Camera

    Aston Martin is recalling certain 2024-2025 DB12, Vantage, and DBX707 vehicles. The infotainment home screen menu may obstruct the rearview camera when in reverse, reducing rear visibility and increasing the risk of a crash.

    Product
    ASTON MARTIN — ASTON MARTIN VANTAGE, DBX707, DB12
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25081·2025-01-02

    Euqee Wintergreen Essential Oil Recalled for Unsafe Packaging

    Euqee Wintergreen Essential Oils sold on Amazon.com are recalled because their packaging is not child-resistant, violating federal law. Methyl salicylate in the oil could poison young children if swallowed.

    Product
    Euqee Wintergreen Essential Oils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25082·2025-01-02

    Yaomiao Children's Jewelry Sets Recalled for Dangerous Lead and Cadmium Levels

    Yaomiao children's jewelry sets sold on Amazon contain dangerous levels of lead and cadmium. Consumers should stop using them immediately, keep them away from children, and request a refund from the seller.

    Product
    Yaomiao Children's Jewelry Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25083·2025-01-02

    John Deere ZTrak Zero-Turn Mowers Recalled for Fire and Burn Hazards

    Kawasaki is recalling about 39,000 John Deere ZTrak zero-turn mowers with Kawasaki engines because the voltage regulator can fail, causing the engine to overheat and creating fire and burn hazards. No injuries have been reported to date.

    Product
    John Deere ZTrak™ Zero Turn Mowers with Kawasaki Engines
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0314-2025·2025-01-01

    Kirkland Signature Organic Eggs Recalled Due to Salmonella Risk

    Kirkland Signature Organic Eggs sold at Costco have been recalled due to potential Salmonella contamination. The recalled eggs were distributed to retail facilities in Alabama, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    Kirkland Signature ORGANIC EGGS PASTURE-RAISED 24 EGGS, GRADE A LARGE, NET WEIGHT 48OZ (3 LB) 1.36 kg, UPC 0 96619 10680 6, DISTRIBUTED BY: COSTCO WHOLESALE CORPORATION 730 LAKE DRIVE, ISSAQUAH, WA 98027
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0683-2025·2025-01-01

    Blood glucose ketone meter software bug causes erroneous result transmission

    Nova Biomedical's StatStrip glucose ketone hospital meter (Model 63910) has a software bug that may transmit erroneous results to healthcare systems. The issue affects 1,615 units distributed across the US and internationally.

    Product
    StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0682-2025·2025-01-01

    Blood Glucose Ketone Meter Firmware Bug Causes Inaccurate Test Results

    Software bug in StatStrip Glucose Ketone Hospital Meter System can cause incorrect blood glucose and ketone test results to be transmitted to healthcare data systems. 347 units affected.

    Product
    StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0313-2025·2025-01-01

    Raw Cucumbers Recalled for Potential Salmonella Contamination Risk

    SunFed Produce, Inc. is recalling raw cucumbers distributed nationally and internationally due to potential Salmonella contamination. The recall affects 71,070 cases.

    Product
    Raw cucumbers packaged in cardboard boxes or plastic boxes (RPC) with "SunFed", "Vegetables", or "Agrotato" labeling. 1 1/9 BU CAS Super Slicer Cucumber/10814780010749 1 1/9 BU CAS Select Slicer Cucumber/10814780010756 1 1/9 BU CAS Large Slicer Cucumber/10814780010763 1 1/9 BU
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0681-2025·2025-01-01

    Glucose Hospital Meter Software Bug Transmits Inaccurate Results

    StatStrip Glucose Hospital Meter software bug may transmit erroneous glucose values to healthcare systems, potentially leading to incorrect patient treatment. 2,365 units affected nationwide and internationally.

    Product
    StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0708-2025·2025-01-01

    Cardiac Monitoring Software Failed to Properly Route ECG Events

    Braemar Manufacturing's Monitoring Service Application (versions 6.5-7.4) failed to properly route and review ECG events from July 2022-July 2024 due to a disabled analysis step. This affected about 130,000 units with 41,282 customers nationwide.

    Product
    Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0717-2025·2025-01-01

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Medline Industries recalls specific lots of surgical patties and strips in MAJOR NEURO PACK-LF Convenience kits due to higher-than-expected endotoxin levels detected in raw materials, which may have resulted in out-of-specification finished products.

    Product
    MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0159-2025·2025-01-01

    Prescription chlorpromazine tablets recalled due to manufacturing quality defect

    Glenmark Pharmaceuticals is recalling chlorpromazine hydrochloride 10mg tablets nationwide due to manufacturing deviations that allowed excess N-nitroso impurity.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2025·2025-01-01

    Siemens magnesium reagent cartridges recalled for false measurement results

    Siemens is recalling two lots of Magnesium Flex reagent cartridges due to potential falsely low magnesium measurements. The intermittent error may not be detected by standard quality control procedures.

    Product
    Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0163-2025·2025-01-01

    DULoxetine tablets recalled for excess nitrosamine impurity

    PD-Rx Pharmaceuticals recalls DULoxetine DR 30 mg tablets due to excess nitrosamine impurity above acceptable limits. The affected lots were distributed in Florida, Mississippi, and Wisconsin.

    Product
    DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-0724-2025·2025-01-01

    Medline Surgical Patties and Strips Recalled for Out-of-Spec Endotoxin Contamination

    Medline is recalling surgical patties and strips in custom surgical kits due to higher-than-expected endotoxin levels in raw materials. These may result in out-of-specification endotoxin levels in finished sterile products.

    Product
    Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0746-2025·2025-01-01

    BD FACSLyric Flow Cytometer Power Supply May Fail During Use

    BD FACSLyric flow cytometers are recalled for power supply failures that may prevent the device from powering on, risking specimen loss and potential respiratory effects from fume inhalation.

    Product
    Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cy
    Category
    Medical Device
    Distribution
    Distributed nationwide

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