The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Filters

Agency

Category

Minimum severity

Clear filters

2051–2075 of 39824

  • ModerateFDA (Devices)·Z-1029-2026·2026-01-14

    Intracranial pressure monitors recalled after customer complaints of rebooting

    Sophysa is recalling 105 Pressio 2 ICP Monitoring Systems following customer complaints of the Pressio monitor rebooting.

    Product
    The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0999-2026·2026-01-14

    Radiography systems recalled because collimation may be incorrect between programs

    Siemens Medical Solutions is recalling LUMINOS Lotus Max and Luminos dRF Max systems because switching quickly between organ programs may result in incorrect collimation.

    Product
    LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1026-2026·2026-01-14

    DxI 800 immunoassay analyzers recalled over a failure to restart after shutdown

    Beckman Coulter is recalling 6,457 UniCel DxI 800 analyzers because a potential communication issue may prevent the instrument restarting after a standard shutdown, causing delayed results.

    Product
    Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1036-2026·2026-01-14

    Intracranial pressure monitoring kits recalled over corrosion stains on the needle

    Integra LifeSciences is recalling 1,301 Codman Microsensor Basic Kits over potential corrosion stains on the surface of the 14-gauge Tuohy needle included in the kits.

    Product
    Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1010-2026·2026-01-14

    Laparoscopic trocars recalled over a potentially extended blade obturator length

    Applied Medical Resources is recalling 450 units of the Kii Low Profile Bladed Dual Pack because of the potential for extended length of the blade obturator after assembly.

    Product
    Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1030-2026·2026-01-14

    Heart pump sets recalled after being packaged in the wrong outer carton

    Abiomed is recalling 6 Impella 5.5 with SmartAssist S2 sets because the device was packaged in an incorrect outer box carton.

    Product
    Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0998-2026·2026-01-14

    Laser tracking system recalled over laser information omitted from instructions

    Vision RT is recalling 56 AlignRT InBore systems because information identifying the lasers and their characteristics was omitted from the Instructions for Use.

    Product
    The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1006-2026·2026-01-07

    Ultrasound probe covers recalled over defects that may cause contamination during use

    Sheathing Technologies is recalling 12 units of Sheathes3D vaginal and rectal ultrasound probe covers because product defects may result in contamination during use, posing an infection risk.

    Product
    Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1004-2026·2026-01-07

    Laser probes recalled because they may not pass smoothly through a cannula

    Vortex Surgical is recalling 221 units of its 25ga Illuminated Flex-Tip Laser Probe because some products in the lot are not passing through a 25ga cannula smoothly.

    Product
    Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1007-2026·2026-01-07

    Ultrasound systems recalled over unexpected reboots that damage the transducer

    Philips Ultrasound is recalling 1,721 EPIQ Ultrasound Systems used with the X5-1c transducer because the system may experience an unexpected automatic reboot, resulting in damage to the transducer.

    Product
    Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1005-2026·2026-01-07

    Liquid adhesive vials recalled because the butyrate tube cracks during actuation

    Ferndale Laboratories is recalling 24,589 units of Mastisol Liquid Adhesive because the butyrate tube cracks during actuation, rendering the product unusable.

    Product
    Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1008-2026·2026-01-07

    Laser and endoscopy systems recalled over ferrites omitted from a USB cable

    Beaver-Visitec International is recalling 5 BVI Leos Laser and Endoscopy Systems because ferrites specified for the USB cable assembly were not installed as intended.

    Product
    BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0933-2026·2025-12-31

    Vapor 2000 anesthetic vaporizers recalled over an out of specification component

    Draeger is recalling 431 Vapor 2000 anesthetic vaporizers because a certain component was not delivered within specification and contained impurities. The action is Class I.

    Product
    Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0934-2026·2025-12-31

    Vapor 3000 anesthetic vaporizers recalled over an out of specification component

    Draeger is recalling 188 Vapor 3000 anesthetic vaporizers because a certain component was not delivered within specification and contained impurities. The action is Class I.

    Product
    Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0939-2026·2025-12-31

    Ophthalmic surgical packs recalled over incomplete seals affecting sterility

    Alcon Research is recalling 151 Custom Pak ophthalmic procedure packs because the packs may have incomplete seals affecting sterility. The FDA has classified the action as Class I.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience k
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0974-2026·2025-12-31

    Femoral nails, 300 mm left trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 11 Affixus Antegrade Femoral Nails, model 815609300, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2026·2025-12-31

    Digital radiography systems recalled over exceeding the maximum air kerma rate

    AGFA Healthcare is recalling 35 DR 800 X-ray systems because it is possible to exceed the maximum allowed air kerma rate of 88mGy/min for pulsed fluoroscopy exams.

    Product
    Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2026·2025-12-31

    Bicarbonate reagent recalled over falsely high results from LDH interference

    Beckman Coulter is recalling 36,981 bicarbonate reagents because they may generate falsely high bicarbonate results due to interference with lactate dehydrogenase in the sample.

    Product
    BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2026·2025-12-31

    Femoral nails, 300 mm right trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 11 Affixus Antegrade Femoral Nails, model 815509300, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2026·2025-12-31

    Dialysis concentrate 100325 recalled because safety and efficacy cannot be assured

    Diasol is recalling 74,400 gallons of liquid concentrate for bicarbonate dialysis, product 100325-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0990-2026·2025-12-31

    Dialysis concentrate 100230 recalled because safety and efficacy cannot be assured

    Diasol is recalling 4,400 gallons of liquid concentrate for bicarbonate dialysis, product 100230-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2026·2025-12-31

    Femoral nails, 360 mm right trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509360, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Right, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2026·2025-12-31

    Dialysis concentrate 100225 recalled because safety and efficacy cannot be assured

    Diasol is recalling 186,000 containers of liquid concentrate for bicarbonate dialysis, product 100225-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0976-2026·2025-12-31

    Femoral nails, 340 mm left trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609340, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide