The Recall Desk

Archive

May 2025 recalls

426 recalls were announced in May 2025.

What the numbers show

Critical
5
Severe
112
High
180
Moderate
126
Low
3

Of the 426 recalls this month scored against our rubric, 1% are Critical, 26% are Severe.

301–400 of 426

  • HighNHTSA·25V315000·2025-05-09

    Ford recalls over a million vehicles for rearview camera software error

    Ford is recalling a wide range of 2021-2025 vehicles because a software error may cause the rearview camera image to freeze or go missing. 1,076,138 units are affected.

    Product
    FORD — FORD, LINCOLN F-450 SD, F-550 SD, MUSTANG MACH E, F-350 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V311000·2025-05-09

    Ford Recalls 2025 Bronco and Ranger for Loose Seat Bolts

    Ford is recalling 2025 Bronco and Ranger vehicles because driver's seat bolts may be loose or missing, which could prevent proper occupant restraint during a crash.

    Product
    FORD — FORD BRONCO, RANGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V303000·2025-05-09

    Ford Bronco rear doors may open despite the child safety lock

    Ford is recalling certain 2024 Bronco vehicles because the left-side rear door may be opened from inside the vehicle when the child safety lock is in the ON position.

    Product
    FORD — FORD BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25E033000·2025-05-08

    Chrysler Recalls Mopar Side Curtain Air Bags for Seam Defects

    Chrysler is recalling specific Mopar side curtain air bags because improperly sealed seams may cause insufficient pressure retention, increasing the risk of ejection and injury during a crash.

    Product
    AIR BAGS:SIDE/WINDOW:CURTAIN recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V300000·2025-05-08

    Aston Martin Recalls 2024 Valkyrie Vehicles Due to Wiring Harness Risk

    Aston Martin is recalling 2024 Valkyrie vehicles because incorrect screws may damage the wiring harness, potentially causing loss of critical functions and increasing crash risk.

    Product
    ASTON MARTIN — ASTON MARTIN VALKYRIE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·25253·2025-05-08

    Igloo 90 Qt. Rolling Coolers Recalled for Fingertip Amputation Risk

    Igloo has expanded its recall of 90 Qt. Flip & Tow Rolling Coolers due to tow handle pinching hazards that can cause fingertip amputation or crushing injuries. About 130,000 additional coolers manufactured prior to January 2024 are affected.

    Product
    Igloo 90 Qt. Flip & Tow Rolling Coolers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25252·2025-05-08

    Xylolin Peg Doll Toy Sets Recalled for Choking Hazard Risk

    About 3,400 Xylolin peg doll toy sets sold on Amazon.com are being recalled because the spherical ends of the peg dolls can block a child's airway, posing a choking risk. Consumers should take the product away from children immediately and dispose of it.

    Product
    Xylolin Peg Doll Toy Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V282000·2025-05-08

    Volvo rearview camera image may not display when reversing

    Volvo is recalling certain 2021-2025 vehicles because the rearview camera image may not display when the vehicle is placed in reverse. 413,151 units are affected.

    Product
    VOLVO — VOLVO XC40, V60, S60, S90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25255·2025-05-08

    Delta Gas Ball Valves Recalled Due to Fire and Burn Hazards

    Delta-branded Gas Ball Valves pose fire and burn hazards because small amounts of gas can leak from the valve when it is in the open position. About 3,700 units were sold in the United States.

    Product
    Delta Gas Ball Valves
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25254·2025-05-08

    Yamaha PA-300C AC Power Adaptors Recalled for Burn and Fire Hazards

    Yamaha Corporation of America is recalling about 37,400 PA-300C AC power adaptors that can overheat and ignite. The company has received four reports of adaptors burning or smoking, though no injuries have been reported.

    Product
    YAMAHA PA-300C AC Power Adaptors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25251·2025-05-08

    Vevor Cable Railing Kits Recalled Due to Entrapment Hazard

    Sanven Technology recalls approximately 800 Vevor stainless steel cable railing kits sold online from May 2021 through September 2024 because the bottom hole on the cable support posts poses an entrapment hazard to children.

    Product
    Stainless steel cable railing kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V302000·2025-05-08

    Chrysler Pacifica curtain airbag seams may not retain pressure

    Chrysler is recalling certain 2022-2025 Pacifica and Voyager vehicles because improperly sealed seams may leave the side curtain airbags with insufficient pressure retention.

    Product
    CHRYSLER — CHRYSLER PACIFICA, VOYAGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V297000·2025-05-08

    Ram 2500 and 3500 gear selection displays may be inaccurate

    Chrysler is recalling certain Ram 2500 and 3500 vehicles with a 3.5 inch cluster and column shifter because a software error may make the gear selection display inaccurate.

    Product
    RAM — RAM 2500, 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V301000·2025-05-08

    Thor Motor Coach Recalls Outlaw Motorhomes Due to Step Bracket Defect

    Thor Motor Coach is recalling 2025-2026 Outlaw motorhomes because step bracket bolts may loosen, allowing steps to detach and increase injury risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH OUTLAW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V298000·2025-05-08

    Ram 1500 driver airbags may not be connected properly

    Chrysler is recalling certain 2019-2024 Ram 1500 vehicles because the driver's side airbag may not be connected properly, which can prevent deployment. 71 units affected.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25250·2025-05-08

    Maril Brand Scented Candles Recalled for Laceration and Fire Hazards

    DEMDACO is recalling approximately 3,000 Maril Brand 8-ounce scented candles because the glass container can crack or break while burning, posing laceration and fire hazards. Three incidents of glass breaking have been reported, with no injuries or property damage so far.

    Product
    Maril Brand Scented Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25257·2025-05-08

    Bliss Hair Dryers Recalled for Electrocution and Shock Hazards

    Legend Brands is recalling approximately 500 Bliss hair dryers due to lack of immersion protection, which can cause death or serious injury from electrocution if the dryers fall into water while plugged in. No injuries have been reported.

    Product
    Bliss Hair Dryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·25256·2025-05-08

    Deuter Child Carriers Recalled Due to Fall Hazard

    Deuter USA is recalling Kid Comfort, Kid Comfort Pro, and Kid Comfort Active Child Carriers because hinges on the foldable rear kickstand support leg can crack or break, creating a fall hazard. No injuries have been reported.

    Product
    Kid Comfort, Kid Comfort Pro and Kid Comfort Active Child Carriers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1704-2025·2025-05-07

    Enhanced Verify Evaluation Handset May Fail to Connect to Neurostimulator

    Medtronic Enhanced Verify Evaluation Handsets (CFN HH90130FA) may fail to communicate with neurostimulators due to faster processing speed, causing therapy to stop and patients to experience return of underlying symptoms.

    Product
    Enhanced Verify Evaluation Handset (CFN HH90130FA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1631-2025·2025-05-07

    GE Healthcare Carestation Anesthesia Systems Ventilation Defect Recall

    Certain GE Healthcare Carestation anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Affected systems can still be used safely in Pressure Control Ventilation or Manual ventilation modes.

    Product
    GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1696-2025·2025-05-07

    Quantum Informatics VISION LIVE VUE Patient Monitor Recalled Without FDA Clearance

    Spectrum Medical Ltd. is recalling the Quantum Informatics VISION / LIVE VUE patient monitoring software because it was marketed without required FDA clearance or approval.

    Product
    Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clini
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-1630-2025·2025-05-07

    GE Healthcare Anesthesia Systems Recalled Over Ventilation Failure

    GE Healthcare is recalling certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems because they may not provide effective ventilation in Volume Control Ventilation (VCV) mode. The issue does not affect Pressure Control Ventilation (PCV), PCV-VG, or manual ventilation modes.

    Product
    GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1628-2025·2025-05-07

    GE Healthcare Carestation 650 A1 Anesthesia System Ventilation

    Certain GE Healthcare Carestation 650 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes or manual ventilation can be used.

    Product
    GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1634-2025·2025-05-07

    GE Healthcare Carestation 650c A1 Anesthesia System Ventilation Failure

    GE Healthcare is recalling certain Carestation 650c A1 anesthesia systems worldwide because they may not provide effective ventilation in Volume Control Ventilation mode, limiting patient ventilation options during anesthesia delivery.

    Product
    GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1702-2025·2025-05-07

    Tibial Augment devices recalled for missing screw thread

    Waldemar Link GmbH & Co. KG is recalling Tibial Augment devices distributed nationwide because preassembled Femoral Augment screws were delivered missing their threads.

    Product
    Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1633-2025·2025-05-07

    GE Healthcare CARESTATION Anesthesia Systems Volume Control Ventilation Failure

    GE Healthcare CARESTATION anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation mode. Affected units can deliver ventilation through Pressure Control Ventilation modes or manual ventilation.

    Product
    GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1632-2025·2025-05-07

    GE Healthcare CARESTATION 650C A1 Anesthesia System Ventilation Recall

    GE Healthcare CARESTATION 650C A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Ventilation can be achieved using alternate modes or manual ventilation.

    Product
    GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1638-2025·2025-05-07

    GE Healthcare CARESTATION Anesthesia Systems may not ventilate properly

    GE Healthcare is recalling certain CARESTATION anesthesia systems that may fail to provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes remain functional.

    Product
    GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1635-2025·2025-05-07

    GE Healthcare CARESTATION 750 Anesthesia System Volume Control Ventilation Failure

    Certain GE Healthcare CARESTATION 750 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Affected systems can deliver ventilation through alternative modes or manual ventilation.

    Product
    GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1625-2025·2025-05-07

    GE Healthcare CARESTATION 620 A2 Anesthesia System Ventilation Failure

    Certain GE Healthcare CARESTATION anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Alternative ventilation modes or manual ventilation can be used.

    Product
    GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0399-2025·2025-05-07

    Nicardipine Hydrochloride Injection Recalled for Potential Sterility Loss

    American Regent, Inc. is recalling certain lots of Nicardipine Hydrochloride Injection due to product leakage around the vial neck that could compromise sterility assurance. The recall affects 7,249 cartons distributed nationwide.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1701-2025·2025-05-07

    L-Shaped Femoral Augment with Missing Screw Thread

    Waldemar Link GmbH & Co. KG is recalling L-Shaped Femoral Augments because the preassembled femoral augment screw was missing its thread. The defect could affect the device's structural integrity during orthopedic surgery.

    Product
    L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0398-2025·2025-05-07

    Nicardipine Hydrochloride Injection Recalled for Potential Sterility Issues

    American Regent, Inc. is recalling Nicardipine Hydrochloride Injection due to product leakage around the vial neck that could compromise sterility assurance. The recall affects multiple lots distributed nationwide.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1629-2025·2025-05-07

    GE Healthcare CARESTATION anesthesia systems may not ventilate effectively

    Certain GE Healthcare CARESTATION 620, 650, 650c, 750, and 750c anesthesia delivery systems may not provide effective ventilation in Volume Control Ventilation (VCV) mode. Effective ventilation is available using other ventilation modes or manual ventilation.

    Product
    GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1627-2025·2025-05-07

    GE Healthcare Anesthesia Systems Recalled Over Ventilation Failure

    GE Healthcare is recalling certain Carestation 620/650/650c and 750/750c anesthesia delivery systems because they may not provide effective ventilation in Volume Control Ventilation (VCV) mode. The issue does not affect Pressure Control Ventilation (PCV), PCV-VG, or manual ventilation modes.

    Product
    GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1695-2025·2025-05-07

    Quantum Informatics VIPER Physiological Monitor Recalled for Lack of FDA Clearance

    Spectrum Medical Ltd. is recalling the Quantum Informatics VIPER, a patient monitoring software device, because it was marketed without required FDA clearance. The software is used in operating rooms to provide patient safety information.

    Product
    Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice soluti
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-1637-2025·2025-05-07

    GE Healthcare CARESTATION 750c A1 Anesthesia System Ventilation Defect

    GE Healthcare CARESTATION 750c A1 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Affected units can achieve ventilation through alternative modes or manual operation.

    Product
    GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1624-2025·2025-05-07

    GE Healthcare CARESTATION anesthesia systems ventilation malfunction recall

    GE Healthcare CARESTATION 620 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Effective ventilation is available in Pressure Control or Manual ventilation modes.

    Product
    GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1700-2025·2025-05-07

    Posterior Femoral Augment with Missing Screw Thread Recalled

    Waldemar Link is recalling Posterior Femoral Augments used in knee surgery because some units were delivered with a preassembled screw missing its thread, which could compromise surgical fixation.

    Product
    Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1699-2025·2025-05-07

    Distal Femoral Augment medical device recall for defective screw

    Waldemar Link GmbH & Co. KG is recalling Distal Femoral Augment devices because the preassembled femoral augment screw was missing its thread. The defect may affect proper device function.

    Product
    Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 88
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1626-2025·2025-05-07

    GE Healthcare Carestation 620 SE Anesthesia System Ventilation Defect Recall

    GE Healthcare is recalling certain Carestation 620 SE anesthesia systems (27 units) because they may not provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes remain functional.

    Product
    GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1636-2025·2025-05-07

    GE Healthcare CARESTATION Anesthesia Systems Ventilation Mode Failure Recall

    Certain GE Healthcare CARESTATION 750 A2 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Users should switch to Pressure Control Ventilation or Manual ventilation modes.

    Product
    GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0759-2025·2025-05-07

    Emily Kate's Gluten Free Vanilla Cake recalled for foil contamination

    Emily Kate's Foods is recalling Emily Kate's Gluten Free Vanilla Cake (6.4 oz) due to foil found in cake slices. The affected product was distributed to a consignee in Wisconsin.

    Product
    Emily Kate's Gluten Free Vanilla Cake, Net Wt. 6.4oz, Emily Kate's Foods, Kansas City, KS 66106, UPC 850581007253
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·25V295000·2025-05-07

    2025 Freightliner trucks recalled for insufficient air tank capacity

    Daimler Trucks North America is recalling certain 2025 Freightliner, Western Star, and related models due to undersized air tanks that reduce braking performance and increase crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR 114SD, CASCADIA, BUSINESS CLASS M2, 49X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V293000·2025-05-07

    2025 Polestar 3 vehicles recalled for faulty rearview camera display

    Polestar is recalling certain 2025 Polestar 3 vehicles because the rearview camera image may not display when the vehicle is in reverse, reducing driver visibility and increasing crash risk.

    Product
    POLESTAR — POLESTAR POLESTAR 3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V294000·2025-05-07

    2022–2024 Audi Q5 Engine Cylinder Head Cover Screws Fire Risk

    Volkswagen Group of America (Audi) is recalling certain 2022–2024 Q5 and Q5 Sportback Quattro vehicles due to cylinder head cover screws that may loosen, causing oil leaks and increasing fire risk. Dealers will inspect and replace the screws at no charge.

    Product
    AUDI — AUDI Q5, Q5 SPORTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0744-2025·2025-05-07

    Sundae Shoppe Cookies and Cream Mochi Ice Cream Recalled for Undeclared Wheat and Soy

    Gordon Desserts is recalling Sundae Shoppe Cookies and Cream Mochi Ice Cream due to undeclared wheat and soy allergens. The product was distributed to Connecticut, Virginia, Ohio, and Pennsylvania.

    Product
    Sundae Shoppe, Cookies and Cream Mochi Ice Cream, 6 count, 7.5 oz, Plastic sealed tray inside paper carton. 6 Pieces per carton, 8 cartons per shipper. Keep frozen.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1672-2025·2025-05-07

    Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer Recall

    Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers due to incorrect sample barcode identification and processing errors that can result in erroneous and delayed test results.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that meas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2025·2025-05-07

    Belmont Straight Inflow/Outflow Patient Line Kit recalled for potential connector crack

    Belmont Instrument LLC is recalling the Straight Inflow/Outflow Patient Line Kit (Model 902-00037) due to a potential crack in the female connector on the Heat Exchanger set that may cause fluid leaks during use.

    Product
    Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2025·2025-05-07

    Stratus CS Acute Care cTNI TestPak cardiac troponin test recall

    Siemens Healthcare Diagnostics is recalling Stratus CS Acute Care cTNI TestPak, a cardiac troponin I test, due to an increased occurrence of false positive results during the product's shelf life.

    Product
    Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0751-2025·2025-05-07

    Dinstuhl's Pecan Brittle recalled for undeclared milk allergen

    Dinstuhl's Fine Candy Company is recalling Dinstuhl's Pecan Brittle (4 oz. bags) because the product contains milk that is not declared on the label, posing a risk to consumers with milk allergies.

    Product
    Dinstuhl's Pecan Brittle, NET WT 4 oz. (113g), individually packaged in cellophane bags; Ingredients: Sugar, Pecans, Corn Syrup, Butter, Baking Soda, Salt, Vanilla.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0750-2025·2025-05-07

    Dinstuhl's Peanut Brittle recalled for undeclared milk allergen

    Dinstuhl's Fine Candy Company is recalling Dinstuhl's Peanut Brittle (4 oz., UPC 7 68050 00205 3) because milk is not declared on the label, posing a risk to consumers with milk allergies.

    Product
    Dinstuhl's Peanut Brittle, NET WT 4 oz. (113g), individually packaged in cellophane bags; Ingredients: Sugar, Corn Syrup, Baking Soda, Peanuts, Butter, Pure Vanilla Extract.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1711-2025·2025-05-07

    Medline Wound Care and Laceration Procedure Kits Recalled for Leaking Bottles

    Medline is recalling Sterile Water and Sterile 0.9% Normal Saline bottles in wound care and laceration procedure kits due to leaking at the peel-foil and bottle opening interface.

    Product
    Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0758-2025·2025-05-07

    La Victoria Cilantro Salsa recalled for wood pieces in ingredient

    La Victoria Cilantro Salsa (15.5 oz) is being recalled because the fresh cilantro ingredient may contain wood pieces. The product was distributed to California, Nevada, Oregon, Washington, and Michigan.

    Product
    La Victoria Cilantro Salsa; Med; Net Wt 15.5 OZ; UPC# 0 72101 34470 3; Distributed by: Megamex Foods, LLC Orange, CA 92868
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1684-2025·2025-05-07

    epoc BGEM BUN Test Cards for Blood Analysis System Recalled

    Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards (25 pk) due to discrepant high pH results when samples are introduced with higher injection volumes on affected sensor configurations.

    Product
    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Leaking at Seal Interface

    Medline is recalling sterile water and 0.9% normal saline bottles due to leaking at the peel-foil and bottle opening interface. The defect affects 159 units distributed nationwide and internationally.

    Product
    Medline procedure kits, labeled as: HAND, REF DYNJ902002J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0742-2025·2025-05-07

    Multigrain Sourdough Bread Recalled for Glass Fragment Contamination

    Upper Crust Bakery LP is recalling 18 oz packages of Multigrain Sourdough bread (Lot #90) because glass fragments have been found on top of the bread. The product was distributed to PA, CA, CT, MD, DE, and OH.

    Product
    Multigrain Sourdough , 18 oz, Paper carton (corrugated), CP12, Frozen
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0745-2025·2025-05-07

    Multigrain Sourdough Bread Recalled for Potential Glass Foreign Material

    Giant Eagle, Inc. is recalling Multigrain Sourdough Freshly Baked and Half Multigrain Sourdough Artisan Bread due to potential glass contamination. The recall affects 240 cases distributed to PA, OH, MD, IN, and WV.

    Product
    Multigrain Sourdough Freshly Backed, and Half Multigrain Sourdough Artisan Bread, 15 oz; 7 oz, Bag, 1 unit
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0749-2025·2025-05-07

    Dinstuhl's Cashew Crunch Recalled for Undeclared Milk Allergen

    Dinstuhl's Fine Candy Company is recalling Dinstuhl's Cashew Crunch 4 oz. packages due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    Dinstuhl's Cashew Crunch, NET WT 4 oz. (113g), individually packaged in cellophane bags; Ingredients: Sugar, Cashews, Coconut, Corn Syrup, Brown Sugar, Butter, Salt, Baking Soda.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0741-2025·2025-05-07

    Ancient Grains Hoagie Roll recalled for glass fragment contamination

    Upper Crust Bakery LP is recalling Ancient Grains Hoagie Rolls due to glass fragments found on the product surface. The affected frozen rolls were distributed to six states.

    Product
    Ancient Grains Hoagie Roll, 4 oz, Paper carton (corrugated), CP45, Frozen
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0743-2025·2025-05-07

    Frozen Whole Grain Multigrain Bread Recalled for Glass Fragment

    Upper Crust Bakery LP is recalling frozen whole grain multigrain bread due to the presence of a glass fragment on the product. The affected 20 oz packages were distributed to PA, CA, CT, MD, DE, and OH.

    Product
    Whole Grain Multigrain , 20 oz, Paper carton (corrugated), CP12, Frozen
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0748-2025·2025-05-07

    Cookie Butter Banana Pie recalled for undeclared almond allergen

    Dianne's Fine Desserts is recalling Cookie Butter Banana Pie due to undeclared almonds. Consumers with almond allergies face risk of allergic reaction.

    Product
    Outer carton labeled: "Cookie Butter Banana Pie" Inner carton labeled: "Tropical Key Lime Pie" Product contained inside: "Cookie Butter Banana Pie" NET WT. 11 LB 2.8 OZ (5.06 kg) GROSS WT: 12.96 LB (5.88 kg)
    Category
    Food
    Distribution
    16 states
  • HighFDA (Food)·F-0747-2025·2025-05-07

    Caraluzzi's Italian Style Seafood Burgers recalled for undeclared egg allergen

    Caraluzzi's Markets is recalling Italian Style Seafood Burgers because they contain undeclared egg, a major food allergen. Consumers with egg allergies who purchased these 8oz burgers should not eat them.

    Product
    Caraluzzi's Italian Style Seafood Burgers, 8oz; INGREDIENTS: Cod, Salmon, Shrimp, Scallops, Onions, Olive Oil, White Wine, Parsley, Sodium Caseinate (A Milk Derivative), Spices, Garlic, Salt, Paprika, Enzyme.; CONTAINS: Crustacean Shellfish, Fish, Milk; Distributed by Caraluzzi's
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0396-2025·2025-05-07

    Levothyroxine Sodium Tablets 88 mcg Recall for Subpotency

    Accord Healthcare is recalling Levothyroxine Sodium Tablets 88 mcg (Lot D2300044, expiring 12/2025) nationwide because the tablets are subpotent—below the required strength. Patients on this medication should contact their pharmacy or prescriber.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2025·2025-05-07

    Belmont 3.0 Liter Disposable Set Recalled for Cracked Female Connector

    Belmont Instrument LLC is recalling the 3.0 Liter Disposable Set (Model 903-00032) due to a potential crack in the female connector on the Heat Exchanger/patient line set that can cause fluid leaks during device priming.

    Product
    3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1689-2025·2025-05-07

    IceSeed 1.5 CX Cryoablation Needles Recalled for Incorrect Software Settings

    Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured between April 2024 and February 2025 due to incorrect software programming. Affected needles may prompt unnecessary Needle Integrity and Functionality Tests if disconnected and reconnected during use.

    Product
    IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1709-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Recalled for Leaking Seals

    Medline Industries is recalling Sterile Water and Sterile 0.9% Normal Saline bottles due to leaking at the peel-foil and bottle opening interface. The affected kits were distributed nationwide and internationally.

    Product
    Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF EDUC102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0760-2025·2025-05-07

    Emily Kate's Gluten Free Carrot Cake recalled for foreign material

    Emily Kate's Gluten Free Carrot Cake (6.4 oz) is being recalled because foil has been found in cake slices. The affected product was distributed to one location in Wisconsin.

    Product
    Emily Kate's Gluten Free Carrot Cake, Net Wt. 6.4oz, Emily Kate's Food, LLC, Kansas City, KS 66106, UPC 850581007284
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0390-2025·2025-05-07

    Tirofiban Hydrochloride Injection recalled for out-of-specification test results

    Eugia US LLC is recalling Tirofiban Hydrochloride Injection due to out-of-specification test results for related substances found during a three-month stability study under long-term storage conditions.

    Product
    TIROFIBAN — TIROFIBAN (TIROFIBAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0389-2025·2025-05-07

    Tirofiban Injection Recalled for Out-of-Specification Test Results

    Eugia US LLC is recalling Tirofiban Hydrochloride Injection due to out-of-specification test results for related substances found during stability testing. The affected lot was distributed nationwide.

    Product
    TIROFIBAN — TIROFIBAN (TIROFIBAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0392-2025·2025-05-07

    Dexonto 0.4% Dexamethasone Solution Recalled for Incorrect Expiration Dating

    Nubratori, Inc. is recalling Dexonto 0.4% dexamethasone sodium phosphate solution because some outer boxes are labeled with an incorrect expiration date (12/25/2025 instead of 12/25/2024), creating risk of use after actual expiration.

    Product
    Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0397-2025·2025-05-07

    Levothyroxine Sodium Tablets Nationwide Recall Due to Subpotency

    Accord Healthcare is recalling approximately 18,984 bottles of Levothyroxine Sodium Tablets, 112 mcg, nationwide because the tablets are subpotent. Patients taking this medication should contact their pharmacy or healthcare provider immediately.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0401-2025·2025-05-07

    Infuvite Adult Multiple Vitamins Injection Recalled Due to Cold Chain Failure

    Certain Infuvite Adult injectable vitamins were exposed to inadequate storage conditions after severe thunderstorms caused shipping delays exceeding 48 hours. The affected products' safety, quality, and potency may have been compromised.

    Product
    INFUVITE ADULT — INFUVITE ADULT (MULTIPLE VITAMINS INJECTION)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1661-2025·2025-05-07

    Trimble RTS873 Robotic Total Station Green Laser Safety Issue

    Trimble is recalling 127 RTS873 robotic total stations because the green aiming laser output power may exceed its Class 2 laser safety classification. Units were produced between October 2023 and February 12, 2025 and distributed in the US, South Korea, and United Kingdom.

    Product
    The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliability in their layout tasks. The integrated Class 2 green aiming laser system enhances visibility and accuracy, even on uneven surfaces. It is i
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0394-2025·2025-05-07

    Levothyroxine Sodium Tablets Recalled for Subpotency by Accord Healthcare

    Accord Healthcare is recalling 4,888 bottles of Levothyroxine Sodium Tablets (25 mcg) nationwide due to subpotency. The affected lot is D2300323 with expiration date 01/2026.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0400-2025·2025-05-07

    Medroxyprogesterone Acetate Injectable Suspension Recalled Due to Cold Chain Disruption

    Medroxyprogesterone Acetate Injectable Suspension (150 mg/mL) distributed to medical facilities in Mississippi and Florida is recalled because severe thunderstorms caused shipping delays that may have compromised the product's storage conditions and safety.

    Product
    Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1713-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Recalled for Leaking

    Medline Industries is recalling Sterile Water and Sterile 0.9% Normal Saline bottles due to leaking at the peel-foil and bottle opening interface. The affected kits were distributed nationwide and internationally.

    Product
    Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1703-2025·2025-05-07

    myQA iON dosimetry device analysis result miscalculation issue

    IBA Dosimetry GmbH is recalling the myQA iON dosimetry device (Article Number MQ10-000) because creating two structures with identical names except for a special character causes wrong analysis results.

    Product
    myQA iON; Article Number: MQ10-000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1687-2025·2025-05-07

    Boston Scientific IceSeed CX Cryoablation Needles Incorrectly Programmed

    Boston Scientific is recalling IceSeed 1.5 CX S cryoablation needles manufactured April 2024 to February 2025 that were programmed with DEMO instead of Commercial settings. If disconnected and reconnected after initial testing, the system will re-prompt testing rather than functioning normally.

    Product
    IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1707-2025·2025-05-07

    Medline procedure kits recalled for leaking sterile water and saline bottles

    Medline procedure kits containing sterile water and 0.9% normal saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface. The kits were distributed worldwide including the US, Panama, and Canada.

    Product
    Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1706-2025·2025-05-07

    Medline Sterile 0.9% Normal Saline 100mL bottles recalled for leaks

    Medline Sterile 0.9% Normal Saline 100mL bottles are being recalled because they may leak at the interface where the peel-foil meets the bottle opening. The bottles were distributed nationwide in the US and in Panama and Canada.

    Product
    Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1710-2025·2025-05-07

    Medline Plastics Suture Tray recalled due to leaking sterile liquid bottles

    Medline is recalling Plastics Suture Tray kits (Ref SUT13535) because the included Sterile Water and Sterile 0.9% Normal Saline bottles leak at the peel-foil and bottle opening interface.

    Product
    Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1705-2025·2025-05-07

    Medline Sterile Water USP bottles recalled for leaking at peel-foil interface

    Medline Sterile Water, USP 100mL bottles are being recalled because they leak at the interface between the peel-foil and bottle opening, posing a contamination risk.

    Product
    Medline Sterile Water, USP, 100mL, REF RDI30295
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0393-2025·2025-05-07

    Wegovy injection recalled due to temperature exposure during shipping

    Cardinal Health is recalling Wegovy (semaglutide) 2.4 mg injection due to temperature abuse during shipping. Product was removed from refrigerated storage for an extended period due to a distribution center error.

    Product
    Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1715-2025·2025-05-07

    Olympus SOLTIVE Pro SuperPulsed Laser System procedural parameter issue

    Olympus is recalling the SOLTIVE Pro SuperPulsed Laser System because preset treatment parameters may not be consistently applied according to the instructions for use.

    Product
    Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and poten
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1685-2025·2025-05-07

    epoc BGEM Crea Test Card for Blood Analysis System recalled

    Siemens Healthcare Diagnostics is recalling epoc BGEM Crea Test Card (25 pk) units due to discrepant high pH results in samples with higher injection volumes. The recall affects 5,207 units distributed nationwide and internationally.

    Product
    epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1674-2025·2025-05-07

    Hyperthermia Pump Procedure Kit Recalled for Cracked Connector

    Belmont Instrument LLC is recalling 158 Hyperthermia Pump Procedure Kits (Model 902-00045) due to a potential crack in the female connector on the Heat Exchanger set that may cause fluid leakage during use.

    Product
    Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and HP Procedu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1692-2025·2025-05-07

    Defibtech Automated External Defibrillators Model DDU-2300 Recalled

    Defibtech is recalling Automated External Defibrillators Model DDU-2300 distributed in Switzerland because Italian-language labeling and instructions were not included, violating Swiss Medical Devices Ordinance requirements.

    Product
    Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310E3/1¿(German/French dual language), DCF-E2310F3/1¿ (French/English dual language), DCF-E2310G3/1¿(French/German dual language), DCF-E2310IT (Italian language)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1708-2025·2025-05-07

    Medline Non Sterile I&D Kit Procedure Kits Recalled for Leaking Bottles

    Medline Industries is recalling Non Sterile I&D Kit procedure kits (Lot 23KDB283) because Sterile Water and Sterile 0.9% Normal Saline bottles leak at the peel-foil and bottle opening interface. The kits were distributed worldwide, including the US, Panama, and Canada.

    Product
    Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1676-2025·2025-05-07

    Belmont Hyperthermia Pump Line Kit Heat Exchanger Connector Crack Recall

    Belmont Instrument is recalling the Straight Inflow/Bifurcated Outflow Line Kit (Model 902-00038) due to potential cracks in the female connector on the Heat Exchanger set, which may cause fluid leaks during priming.

    Product
    Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00038) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1688-2025·2025-05-07

    IceSeed CX Cryoablation Needles Recalled for Demo Programming Issue

    Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured between April 2024 and February 2025 because they were programmed with demo settings instead of commercial settings. If disconnected and reconnected during use, the system will prompt unnecessary recalibration testing.

    Product
    IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1683-2025·2025-05-07

    HistoCore PELORIS 3 Rapid Tissue Processor Manifold Tubing Leakage

    Leica Biosystems is recalling 77 units of the HistoCore PELORIS 3 Rapid Tissue Processor due to a leakage issue in the manifold tubing. The affected units were distributed across 14 US states.

    Product
    HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1686-2025·2025-05-07

    IceSeed 1.5 CX S Cryoablation Needle Programmed with Incorrect Settings

    Boston Scientific is recalling 435 IceSeed 1.5 CX S cryoablation needles manufactured between April 2024 and February 2025 that were programmed with DEMO settings instead of Commercial settings, which can cause the Cryoablation System to prompt repeated tests if the needle is disconnected and reconnected.

    Product
    IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1693-2025·2025-05-07

    Automated External Defibrillator Model DDU-2450 Missing Italian Translation

    Defibtech, LLC is recalling one Automated External Defibrillator Model DDU-2450 (German language version) distributed in Switzerland because it lacks required Italian language labeling and instructions for use.

    Product
    Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1712-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Recalled for Leaking Peel-Foil Seals

    Medline procedure kits containing Sterile Water and Sterile 0.9% Normal Saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface.

    Product
    Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0395-2025·2025-05-07

    Levothyroxine Sodium Tablets 50 mcg Recalled for Subpotency

    Accord Healthcare is recalling 4,872 bottles of Levothyroxine Sodium Tablets (50 mcg) nationwide because the tablets are subpotent and may not provide the intended therapeutic effect.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0391-2025·2025-05-07

    Clindamycin Hydrochloride Capsules Recalled for cGMP Deviations

    Preferred Pharmaceuticals, Inc. is voluntarily recalling Clindamycin Hydrochloride Capsules USP 300mg due to manufacturing process deviations. The recall affects 1190 bottles distributed nationwide.

    Product
    Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
    Category
    Drug
    Distribution
    Distributed nationwide

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