The Recall Desk

Archive

March 2025 recalls

446 recalls were announced in March 2025.

What the numbers show

Critical
7
Severe
95
High
303
Moderate
37
Low
4

Of the 446 recalls this month scored against our rubric, 2% are Critical, 21% are Severe.

1–100 of 446

  • SevereNHTSA·25E022000·2025-03-31

    Our Next Energy Recalls Aries LFP Battery Packs for Commercial Trucks

    Our Next Energy is recalling Aries LFP battery packs for commercial trucks because improper sealing may allow liquid entry, increasing the risk of fire or shock.

    Product
    ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·PHA-03312025-01·2025-03-31

    USDA Issues Public Health Alert for White Chicken Chili Imported Without Inspection

    USDA FSIS issued a public health alert for Allen Family Foods White Chicken Chili imported from Canada without required reinspection. No illnesses have been reported.

    Product
    FSIS Issues Public Health Alert for White Chicken Chili Imported Without the Benefit of Import Reinspection
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·25V198000·2025-03-28

    Ford 3.5L engines can leak oil rapidly from misaligned cup plug

    Ford is recalling certain 2024-2025 F-150, Expedition and 2024 Lincoln Navigator vehicles with 3.5L GTDI engines because a misaligned engine cup plug can cause a rapid oil leak.

    Product
    FORD — FORD, LINCOLN EXPEDITION, F-150, NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V200000·2025-03-28

    Great Dane Recalls 2025-2026 Champion Trailers Due to Tire Defect

    Great Dane is recalling 2025-2026 Champion Dry Van trailers equipped with specific Bridgestone tires that may fail due to incorrect manufacturing.

    Product
    GREAT DANE — GREAT DANE CHAMPION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V199000·2025-03-28

    Ford Recalls 2025 F-150 Hybrid Vehicles Due to Fuse Defect

    Ford is recalling 2025 F-150 Hybrid vehicles because an incorrect fuse in the high-voltage battery junction box may fail, causing a sudden loss of drive power.

    Product
    FORD — FORD F-150 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·009-2025·2025-03-28

    Cargill Recalls Liquid Egg Products Due to Unapproved Cleaning Solution

    Cargill Kitchen Solutions is recalling approximately 212,268 pounds of liquid egg products that may contain a cleaning solution with sodium hypochlorite.

    Product
    Cargill Kitchen Solutions, Inc. — Cargill Kitchen Solutions Recalls Liquid Egg Products Due to an Unapproved Substance
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·25200·2025-03-27

    Specialized E-Bikes Recalled Due to Chain Guard Entrapment Fall Hazard

    Specialized Vado and Como IGH e-bikes have defective chain/belt guards that do not fully cover the belt drive, allowing loose clothing to become entrapped and cause falls. About 32,400 units were sold in the US.

    Product
    Specialized Vado and Como IGH E-Bikes with Chain Guards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25202·2025-03-27

    Wooden dressers recalled for tip-over and entrapment hazards

    George Oliver wooden dressers sold on Wayfair.com are unstable without proper wall anchoring, posing tip-over and entrapment hazards. About 220 units were sold; no injuries reported.

    Product
    George Oliver Dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25201·2025-03-27

    NFH Iron Dietary Supplement Bottles Lack Required Child-Resistant Packaging

    About 17,660 NFH iron dietary supplement bottles lack child-resistant packaging required by federal law, posing a poisoning risk to young children. No injuries have been reported.

    Product
    NFH Iron SAP, NFH Heme Iron SAP and NFH Prenatal SAP bottles
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·25V194000·2025-03-27

    BMW Recalls 2024-2025 M 1000 R and XR Motorcycles for Steering Defect

    BMW is recalling 2024-2025 M 1000 R and M 1000 XR motorcycles because a loose valve pin in the steering damper may cause increased steering effort and loss of control.

    Product
    BMW — BMW M 1000 R, M 1000 XR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25199·2025-03-27

    APOTHEKE Pumpkin Ginger Scented Candles Recalled for Fire and Burn Hazards

    APOTHEKE's Pumpkin Ginger 3-wick candles can overheat and break their glass containers, posing fire and burn hazards. About 640 units were sold at Crate & Barrel from June 2024 through January 2025.

    Product
    APOTHEKE's Pumpkin Ginger 3-Wick Scented Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V192000·2025-03-27

    Oshkosh Recalls 2024-2025 NGDV Vehicles for Loose Wiper Arm Nuts

    Oshkosh is recalling 2024-2025 NGDV vehicles because loose wiper arm nuts may cause wiper failure, reducing driver visibility and increasing crash risk.

    Product
    OSHKOSH — OSHKOSH NGDV ELECTRIC, NGDV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25197·2025-03-27

    Cra-Z-Art Gemex and Gel2Gem Jewelry Kits Recalled for Chemical Irritation Risk

    LaRose Industries is recalling about 224,100 Cra-Z-Art Gemex and Gel2Gem jewelry kits because the resin liquid can cause skin, eye, and respiratory irritation in children when inhaled, touched, or ingested.

    Product
    Cra-Z-Art Gemex/Gel2Gem Jewelry Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1279-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Component Separation Due to Manufacturing Defect

    Smiths Medical is recalling ProPort Plastic implantable port systems because the plastic port housing and port reservoir may separate due to a manufacturing defect. The recall affects 2,311 units distributed worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1278-2025·2025-03-26

    Smiths Medical ProPort Implantable Venous Ports Recalled for Separation Defect

    Smiths Medical has recalled 643 ProPort Plastic implantable venous access ports that may separate due to a manufacturing defect. The recall affects units distributed worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1286-2025·2025-03-26

    Smiths Medical ProPort Implantable Port May Separate Due to Manufacturing Defect

    Smiths Medical is recalling ProPort Plastic Venous Access Ports because the port housing and reservoir may separate due to a manufacturing defect. Contact your physician if you have an affected device.

    Product
    smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0657-2025·2025-03-26

    Strawberry Nutritional Shake Recalled Due to Listeria Contamination Risk

    Lyons Magnus is recalling Ready Care and Imperial brand Strawberry Shakes (No Sugar Added) due to potential Listeria monocytogenes contamination. The affected products were distributed to healthcare facilities nationwide.

    Product
    Ready Care Strawberry Shake No Sugar Added (4 oz), UPC 10045796017372; Imperial Strawberry Shake No Sugar Added (4 oz), UPC 00074865926843
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1280-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Housing May Separate Due to Manufacturing Defect

    Smiths Medical is recalling 9,506 ProPort implantable venous access ports due to a manufacturing defect that may cause the port housing and reservoir to separate. No injuries have been reported.

    Product
    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1287-2025·2025-03-26

    Smiths Medical ProPort Venous Ports Recalled for Potential Housing Separation

    Smiths Medical is recalling ProPort Low Profile Plastic Venous Access Systems because the plastic port housing and reservoir may separate due to a manufacturing defect. Approximately 8,515 units worldwide are affected.

    Product
    smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0646-2025·2025-03-26

    Enoki Mushrooms Recalled Due to Listeria Monocytogenes Contamination

    Daily Veggies Enoki Mushroom from New Age International is being recalled because of Listeria monocytogenes contamination. Consumers who purchased this product should not consume it.

    Product
    Daily Veggies Enoki Mushroom; Product of Korea; Net WT. 200 g (7.05 oz); KEEP REFRIGERATED; Cook through before
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1277-2025·2025-03-26

    Smiths Medical ProPort Plastic Venous Access System Recalled

    Smiths Medical is recalling the ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and reservoir to separate.

    Product
    smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0653-2025·2025-03-26

    Lyons Magnus chocolate shakes recalled due to potential Listeria contamination

    Two chocolate shake products from Lyons Magnus are being recalled due to potential Listeria monocytogenes contamination affecting approximately 763,250 cases distributed to healthcare facilities nationwide.

    Product
    Ready Care Chocolate Shake (4 oz), UPC 10045796017341; Imperial Chocolate Shake (4 oz), UPC 00074865926997
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0661-2025·2025-03-26

    Ready Care Strawberry Shake Recalled for Potential Listeria Contamination

    Lyons Magnus LLC is recalling Ready Care Strawberry Shake Plus (4 oz) due to potential Listeria monocytogenes contamination. The affected product has been distributed to healthcare facilities nationwide.

    Product
    Ready Care Strawberry Shake Plus (4 oz), UPC 10045796017495
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0655-2025·2025-03-26

    Vanilla Shake Products Recalled Due to Potential Listeria Contamination

    Lyons Magnus is recalling Ready Care and Imperial Vanilla Shake products for potential Listeria monocytogenes contamination. The affected products were distributed to healthcare facilities nationwide.

    Product
    Ready Care Vanilla Shake (4 oz), UPC 10045796017334; Imperial Vanilla Shake (4 oz), UPC 00074865926836
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0656-2025·2025-03-26

    Ready Care and Imperial Chocolate Shakes Recalled for Listeria Contamination Risk

    Lyons Magnus LLC is recalling Ready Care and Imperial Chocolate Shakes due to potential Listeria monocytogenes contamination. The recalled products were distributed nationwide to healthcare facilities and long-term care settings.

    Product
    Ready Care Chocolate Shake No Sugar Added (4 oz), UPC 10045796036335; Imperial Chocolate Shake No Sugar Added (4 oz), UPC 10734730244720
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1288-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Plastic Housing May Separate

    The ProPort Low Profile Plastic Venous Access System is being recalled because the port housing and port reservoir may separate due to a manufacturing defect, affecting approximately 2,236 units distributed worldwide.

    Product
    smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1284-2025·2025-03-26

    Smiths Medical ProPort Venous Access System Recalled for Port Separation Risk

    Smiths Medical is recalling ProPort Plastic Venous Access Systems due to a manufacturing defect that can cause the port housing and reservoir to separate. This may result in device failure affecting patients worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1281-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Risk of Component Separation

    Smiths Medical is recalling its ProPort Plastic Implantable Ports due to a manufacturing defect that may cause the port housing and reservoir to separate, potentially compromising device function.

    Product
    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0654-2025·2025-03-26

    Lyons Magnus Recalls Strawberry Shakes for Potential Listeria Contamination

    Lyons Magnus LLC is recalling Ready Care and Imperial Strawberry Shake products due to potential Listeria monocytogenes contamination. The recall affects 763,250 cases distributed to healthcare facilities.

    Product
    Ready Care Strawberry Shake (4 oz), UPC 10045796017358; Imperial Strawberry Shake (4 oz), UPC 00074865927017
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0662-2025·2025-03-26

    Ready Care Vanilla Shake Plus 4 oz Recalled for Listeria Contamination

    Lyons Magnus LLC is recalling Ready Care Vanilla Shake Plus (4 oz, UPC 10045796017549) due to potential contamination with Listeria monocytogenes. The product was distributed to hospitals, nursing homes, and long-term care facilities across the United States.

    Product
    Ready Care Vanilla Shake Plus (4 oz), UPC 10045796017549
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0659-2025·2025-03-26

    Vanilla shakes recalled due to potential Listeria contamination

    Lyons Magnus LLC is recalling Ready Care and Imperial brand vanilla shakes (4 oz) due to potential Listeria monocytogenes contamination. The affected products were distributed to long-term care facilities, skilled nursing homes, and hospitals across the U.S.

    Product
    Ready Care Vanilla Shake No Sugar Added (4 oz), UPC 10045796017365; Imperial Vanilla Shake No Sugar Added (4 oz), UPC 00074865927031
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0658-2025·2025-03-26

    Ready Care and Imperial Shakes Recalled for Listeria Contamination Risk

    Ready Care and Imperial Strawberry Banana Shakes are being recalled due to potential Listeria monocytogenes contamination. The affected products were distributed to long-term care facilities, hospitals, and nursing homes.

    Product
    Ready Care Strawberry Banana Shake No Sugar Added (4 oz), UPC 10045796018447; Imperial Strawberry Banana Shake No Sugar Added (4 oz), UPC 00074865987325
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1285-2025·2025-03-26

    Smiths Medical ProPort Plastic Venous Access System Recalled for Port Housing Separation Risk

    Smiths Medical is recalling certain ProPort Plastic Venous Access System devices due to a manufacturing defect that may cause the port housing and reservoir to separate.

    Product
    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0281-2025·2025-03-26

    Dietary Supplement Tainted with Undeclared Sildenafil and Tadalafil

    Vitality male enhancement dietary supplement recalled nationwide. Product contains undeclared prescription drugs sildenafil and tadalafil not disclosed to consumers.

    Product
    Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0660-2025·2025-03-26

    Ready Care Chocolate Shake Plus Recalled for Potential Listeria Contamination

    Lyons Magnus LLC is recalling Ready Care Chocolate Shake Plus (4 oz) due to potential Listeria monocytogenes contamination. The recall affects 763,250 cases distributed to long-term care facilities, skilled nursing homes, and hospitals.

    Product
    Ready Care Chocolate Shake Plus (4 oz), UPC 10045796017471
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1283-2025·2025-03-26

    Smiths Medical ProPort Plastic Implantable Ports Recalled for Port Housing Separation

    Smiths Medical is recalling 1961 units of ProPort Plastic Implantable Ports worldwide due to a manufacturing defect that may cause the port housing and reservoir to separate. This Class I recall affects patients dependent on venous access systems.

    Product
    smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0638-2025·2025-03-26

    Berry Buddies breakfast cups recalled for undeclared wheat and egg allergens

    Berry Buddies fruit-and-pancake cups are being recalled because the back label does not list wheat and eggs as allergens. People with allergies to these ingredients could have serious reactions.

    Product
    Berry Buddies; Blueberries, Mini Pancakes & Real Maple Syrup; NET WT 2.1 oz (60 g); 3-compartment non-flex plastic container with heat-sealed plastic film containing mini pancakes, blueberries, and maple syrup
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1282-2025·2025-03-26

    Smiths Medical ProPort Plastic Venous Access System recalled for port separation defect

    Smiths Medical is recalling its ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and reservoir to separate, affecting 1,695 units distributed worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1399-2025·2025-03-26

    VERICIS Merge Cardio may display inconsistent measurement data in clinical reports

    The VERICIS Merge Cardio system may display inconsistent cardiovascular measurements in patient reports when specific workflows are used. This could affect clinical decisions based on the reported data.

    Product
    VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·25V190000·2025-03-26

    Micro Bird Recalls G5 School Buses for Missing Seat Reinforcements

    Micro Bird is recalling certain G5 school buses because seat reinforcement supports may be missing, which could cause seats to detach in a crash.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1392-2025·2025-03-26

    Medical Device Software May Merge Patient Records Without Notification

    Brainlab's Origin Data Management software versions 3.1.0 through 3.2.1 may automatically merge patient records from unrelated individuals without user notification, creating a risk of incorrect patient data being used in clinical care.

    Product
    Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0649-2025·2025-03-26

    Chocolate Peanut Butter Protein Balls Recalled for Undeclared Allergens and Food Additives

    Prep'd CDA LLC is recalling Chocolate Peanut Butter Protein Balls due to undeclared soy lecithin and undeclared food color additives. Consumers with soy allergies should not consume the product.

    Product
    Chocolate Peanut Butter Protein Balls. Product has expected life of 2 weeks and does not require refrigeration. Product is packaged in sets of 2 protein balls into resealable plastic baggies. Net Wt. 78 grams.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1363-2025·2025-03-26

    Medline Proxima sterile surgical drapes recalled due to potential packaging breach

    Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.

    Product
    Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0650-2025·2025-03-26

    Chef's Line Black Bean Burgers Recalled for Foreign Object

    Chef's Line US Foods black bean burgers are being recalled because a bolt was found in the product. The recalled product was distributed to Illinois, Maryland, New Jersey, Pennsylvania, and Delaware.

    Product
    Chef's Line US Foods, Black Bean Burger, 36/4.25 oz., Product in a plastic bag in a cardboard box. approx. 36 pieces per case. Keep Frozen,
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1360-2025·2025-03-26

    Lumbar Spine Pack Recalled Due to Sterilization Assurance Failure

    American Contract Systems Inc is recalling 106 SPINE LUMBAR PACK kits (Models UTSL72AA, UTSL72AB) because the manufacturer cannot confirm sterilization assurance requirements were met, potentially causing functionality loss and treatment delays.

    Product
    SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2025·2025-03-26

    IV Catheter Valve Housing May Detach and Cause Leakage

    B. Braun Medical is recalling Introcan Safety 3 IV catheters because the valve housing may detach, causing fluid leakage. Approximately 28,200 units are affected.

    Product
    Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-0642-2025·2025-03-26

    emd Oysterettes Oyster Crackers Recalled for Metal Contamination

    Dairy State Foods Inc is recalling emd Oysterettes oyster crackers due to the possibility of metal contamination. Affected batches have date codes 34824 and 35324 and were distributed in Michigan.

    Product
    emd Oysterettes (oyster crackers in polypropylene film). 0.75 oz. Packed for and Distributed by emd, Detroit, MI 48212.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1368-2025·2025-03-26

    Proxima Drape sterile drapes recalled for potential packaging breach risk

    Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. The recall affects 2,422 units distributed nationwide.

    Product
    Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2025·2025-03-26

    Microstream CO2 sampling lines recalled for difficult adapter disconnection

    Microstream CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended tube removal.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1401-2025·2025-03-26

    Cardiovascular Information System Measurement Inconsistency in Merge Cardio

    Merge Healthcare's VERICIS Merge Cardio cardiovascular information system may display inconsistent measurements under specific workflows involving ultrasound remeasurement or manual measurement editing. No illnesses have been reported.

    Product
    VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1354-2025·2025-03-26

    Diagnostic Neuro IR Tray recalled for unconfirmed sterilization

    American Contract Systems Inc is recalling 170 Diagnostic Neuro IR Tray kits due to inability to confirm sterilization assurance requirements were met. The units may lose functionality and cause treatment delays.

    Product
    DIAGNOSTIC NEURO IR TRAY , Model No WENE21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1389-2025·2025-03-26

    Candida ID Antigen recalled for reduced sensitivity, potential false negatives

    Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.

    Product
    Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0286-2025·2025-03-26

    Injectable Drug Recalled for Stability Issues at Expiration

    Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.

    Product
    NEUPOGEN — NEUPOGEN (FILGRASTIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2025·2025-03-26

    Thoracic Packs Recalled for Unconfirmed Sterilization Assurance by Manufacturer

    American Contract Systems recalls 40 kits of Thoracic Packs (Models UTTC82Y and UTTC82AA-01) due to inability to confirm sterilization assurance was met. Unsterilized packs may lose functionality and delay emergency treatment.

    Product
    THORACIC PACK , Model No UTTC82Y UTTC82AA-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1347-2025·2025-03-26

    Hip Prosthesis Pack Recalled Due to Sterilization Assurance Concerns

    American Contract Systems Inc is recalling TOTAL HIP PACK models SMTH06O and SMTH06P due to inability to confirm sterilization requirements were met. Unsterilized devices could malfunction and delay patient treatment.

    Product
    TOTAL HIP PACK , Model No SMTH06O SMTH06P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0652-2025·2025-03-26

    Chef's Line 3 Grain Slider Buns Recalled for Foreign Material

    Chef's Line US Foods 3 Grain Slider buns are being recalled due to foreign material (a bolt) found in the product. Approximately 8,107 cases were distributed to IL, MD, NJ, PA, and DE.

    Product
    Chef's Line US Foods, 3 Grain Slider , 54/1.8 oz., Product in a plastic bag in a cardboard box. approx. 54 pieces per case. Keep Frozen,
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1388-2025·2025-03-26

    DxI 9000 Access Immunoassay Analyzer Encoder Wheel Misalignment

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (206 units) because an encoder wheel misalignment on the motor shaft can cause the instrument to stop and delay patient test results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1340-2025·2025-03-26

    General Angio Pack Sterilization Assurance Cannot Be Confirmed

    American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.

    Product
    GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1394-2025·2025-03-26

    Medline Medical Convenience Kits Recalled for Defective Plastic Syringes

    Medline is recalling 880 medical convenience kits containing plastic syringes with potential leaks and breakage. The syringes were identified as defective and may pose health risks to patients.

    Product
    Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0280-2025·2025-03-26

    Prasugrel 5 mg Tablets Recalled Due to Failed Dissolution Specifications

    Mylan Pharmaceuticals is recalling specific lots of Prasugrel 5 mg tablets due to failed dissolution specifications. The affected tablets may not dissolve properly in the body.

    Product
    PRASUGREL — PRASUGREL (PRASUGREL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1333-2025·2025-03-26

    Medical Device HIP SCOPE Recall Due to Sterilization Assurance Failure

    American Contract Systems Inc recalls HIP SCOPE orthopedic surgical kits due to inability to confirm sterilization assurance requirements were met. Unsterilized instruments could increase infection risk during surgical procedures.

    Product
    HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1385-2025·2025-03-26

    Microstream neonatal CO2 filter lines difficult to disconnect from breathing tubes

    Microstream Advance neonatal-infant CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying critical procedures. This could cause unintended extubation and respiratory complications in infants.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVIIH; Microstream Advance…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1353-2025·2025-03-26

    Medical Pump Kits Recalled for Unconfirmed Sterilization and Functionality Loss

    American Contract Systems Inc is recalling 134 CV Basic Pump Pack kits because the manufacturer cannot confirm sterilization requirements were met. Possible loss of functionality could delay or prolong patient treatment.

    Product
    CV BASIC PUMP PACK , Model No WECV23D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2025·2025-03-26

    Microstream CO2 Sampling Lines May Be Difficult to Disconnect From Breathing Tubes

    Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially causing treatment delays and unintended extubation with risk of serious complications.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 007737…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2025·2025-03-26

    Surgical drapes recalled due to potential sterility breach in packaging

    Medline Industries is recalling Proxima Drape surgical drapes nationwide due to a potential breach in pouch packaging that could lead to loss of sterility. The recall affects 1,118 units distributed in the US.

    Product
    Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1393-2025·2025-03-26

    Medline C-Section Procedure Kits Recalled for Defective Syringes

    Medline is recalling 456 C-section procedure kits containing plastic syringes affected by an FDA safety alert. The syringes may leak or break, posing a risk to patient health during surgical procedures.

    Product
    Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1369-2025·2025-03-26

    Sterile surgical drapes recalled due to potential packaging breach

    Medline Industries is recalling 220 Proxima Drape sterile surgical drapes nationwide due to a potential breach in pouch packaging that could compromise sterility.

    Product
    Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1365-2025·2025-03-26

    Sterile Surgical Drape Recalled Due to Potential Packaging Breach

    Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.

    Product
    Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0290-2025·2025-03-26

    Levothyroxine Sodium Tablets Recalled for Out-of-Specification Potency

    Mylan Institutional is recalling Levothyroxine Sodium Tablets 150 mcg due to out-of-specification potency. The medication tested higher than specified, affecting 347 cartons distributed nationwide (Lot 3116074, expires 09/30/2025).

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2025·2025-03-26

    Medline Proxima Sterile Surgical Drapes Recalled for Packaging Breach Risk

    Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential packaging breach that could compromise sterility. The recall affects 16 units distributed nationwide.

    Product
    Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0651-2025·2025-03-26

    Chef's Line US Foods 3 Grain Burgers recalled for foreign bolt

    Chef's Line 3 Grain Burgers have been recalled due to a bolt found in the product. The affected cases were distributed to Illinois, Maryland, New Jersey, Pennsylvania, and Delaware.

    Product
    Chef's Line US Foods, 3 Grain Burger - 36/4.25 oz., Product in a plastic bag in a cardboard box. approx. 36 pieces per case. Keep Frozen,
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0644-2025·2025-03-26

    HOT ONES Verde hot sauce recalled for possible plastic contamination

    HOT ONES brand VERDE hot sauce by Heatonist is being recalled due to possible plastic foreign object contamination. Multiple sizes were distributed in North Carolina, Ohio, Indiana, and Illinois.

    Product
    HOT ONES brand VERDE, Los Calientes Hot Sauce, BY HEATONIST; 1 gallon, 5 oz, and 5 gallon sizes; UPC: 8-51444-00803-5
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1351-2025·2025-03-26

    EAR PACK Medical Device Recalled Over Unconfirmed Sterilization

    American Contract Systems Inc is recalling 51 kits of the EAR PACK Model SFEA12A because the manufacturer could not confirm sterilization requirements were met, which could cause device malfunction and delayed treatment.

    Product
    EAR PACK , Model No SFEA12A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1356-2025·2025-03-26

    AV Fistula Kit Recall Due to Unconfirmed Sterilization Assurance

    American Contract Systems Inc is recalling 90 AV Fistula kits because sterilization assurance requirements cannot be confirmed. Possible loss of functionality could delay or prolong patient treatment.

    Product
    AV FISTULA , Model No UTAV77T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1376-2025·2025-03-26

    CO2 Sampling Lines May Fail to Disconnect During Neonatal Care

    Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended extubation. The defect affects neonatal and pediatric patients worldwide.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1348-2025·2025-03-26

    Delivery Pack Medical Device Sterilization Assurance Not Confirmed

    American Contract Systems Inc is recalling Delivery Pack medical devices (Models SGDV22D-01 and SGDV22E) because sterilization assurance requirements were not confirmed. Unsterilized devices may not function properly and could delay treatment.

    Product
    DELIVERY PACK , Model No SGDV22D-01 SGDV22E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2025·2025-03-26

    Proxima Drape surgical drapes recalled due to potential sterility loss

    Medline Industries recalls 506 units of Proxima Drape surgical drapes nationwide due to potential packaging breaches that could compromise sterility. Affected drapes were labeled as MINOR PACK or LAPAROSCOPY variants.

    Product
    Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1336-2025·2025-03-26

    C-Section Surgical Packs Recalled Over Sterilization Assurance Failure

    American Contract Systems is recalling C-Section surgical packs (252 kits) after being unable to confirm sterilization assurance. Lack of verified sterilization could delay or prolong surgical treatment.

    Product
    C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0284-2025·2025-03-26

    CVS Health Concealing Acne Treatment Cream Recalled for Benzene Contamination

    Fruit Of The Earth, Inc. is recalling CVS Health Concealing Acne Treatment Cream due to the presence of benzene, a chemical contaminant. The affected product was distributed nationwide.

    Product
    CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1350-2025·2025-03-26

    Laceration Tray Kits Recalled Due to Sterilization Assurance Failure

    American Contract Systems Inc recalls 690 laceration tray kits due to inability to confirm sterilization requirements were met. The trays may lack functionality and delay patient treatment.

    Product
    LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1342-2025·2025-03-26

    Surgical Positioning Device Recalled for Unconfirmed Sterilization Assurance

    American Contract Systems Inc is recalling C-Section PPS positioning systems due to inability to confirm sterilization assurance requirements were met. The failure could lead to loss of functionality and delayed treatment.

    Product
    C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2025·2025-03-26

    Shoulder Prosthesis Stem Excess Material Prevents Proper Surgical Assembly

    Zimmer Orthopedics recalls shoulder prosthesis models due to excess material in the taper that prevents proper surgical assembly. Five complaints reported.

    Product
    Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1398-2025·2025-03-26

    VERICIS Merge Cardio Cardiovascular System Software Recall for Measurement Inconsistency

    Merge Healthcare's VERICIS Merge Cardio software (versions 9.0.6 and 9.0.8) may produce measurement inconsistencies under specific workflows. Derived measurements may not match primitive measurements in final patient reports.

    Product
    VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1352-2025·2025-03-26

    Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization

    American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.

    Product
    LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2025·2025-03-26

    FDA Recalls URO Robotic Pack Surgical Kit Due to Sterilization Concerns

    American Contract Systems Inc recalls 41 URO Robotic Pack surgical kits distributed in Ohio because sterilization assurance requirements could not be confirmed. Non-sterile equipment may lead to delayed treatment.

    Product
    URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1337-2025·2025-03-26

    Laparoscopy Packs Recalled Due to Unconfirmed Sterilization Assurance

    American Contract Systems Inc is recalling 630 laparoscopy pack kits due to unconfirmed sterilization assurance. This could cause loss of functionality and treatment delays.

    Product
    LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1338-2025·2025-03-26

    Labor and Delivery Pack Recalled Over Unconfirmed Sterilization

    American Contract Systems is recalling 725 Labor & Delivery Packs because the manufacturer cannot confirm sterilization requirements were met. Devices may lack functionality and could delay or prolong patient treatment.

    Product
    LABOR & DELIVERY PACK, Model Nos LLLD19H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1343-2025·2025-03-26

    PICC Line Catheters Recalled for Sterilization Assurance Issues

    American Contract Systems is recalling PICC line catheters because sterilization assurance requirements could not be confirmed. Unsterilized devices may lose functionality and delay patient treatment.

    Product
    CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0277-2025·2025-03-26

    Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Safe Levels

    Rising Pharma is recalling Duloxetine Delayed-Release Capsules 30 mg (Lot DTB23111A) distributed nationwide due to N-nitroso-duloxetine impurity above the FDA's recommended interim limit. This manufacturing impurity resulted from a CGMP deviation.

    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0645-2025·2025-03-26

    HOT ONES Hot Sauce Recalled for Possible Plastic Contamination

    HOT ONES brand ROJO hot sauce is recalled due to possible plastic contamination. The Karma Sauce Company is conducting a precautionary recall of products distributed in North Carolina, Ohio, Indiana, and Illinois.

    Product
    HOT ONES brand ROJO, Los Calientes Hot Sauce, BY HEATONIST; 5 oz size and 1 gallon sizes; UPC: 8-51444-00810-03
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1357-2025·2025-03-26

    General Laparoscopic Pack Recall Due to Unconfirmed Sterilization

    American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.

    Product
    GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0287-2025·2025-03-26

    FDA Recalls Prasugrel Tablets for Failed Dissolution Specifications

    Golden State Medical Supply Inc. is recalling 2,601 bottles of Prasugrel 5 mg tablets due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting drug absorption.

    Product
    PRASUGREL — PRASUGREL (PRASUGREL)
    Category
    Drug
    Distribution
    Distributed nationwide

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