The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

5176–5200 of 88106

  • HighFDA (Devices)·Z-0455-2026·2025-11-19

    Bedside patient monitors recalled over batteries that fail as backup power

    GE Healthcare is recalling 7,408 B105P, B125P, B105M, B125M and B155M patient monitors because certain batteries can lose the ability to hold charge, causing a loss of monitoring.

    Product
    B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160001-065 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0182-2026·2025-11-19

    Dietary supplement recalled because it contains magnesium salicylate

    Professional Botanicals is recalling 430 bottles of Total Comfort capsules because the product contains magnesium salicylate.

    Product
    Product Name: Total Comfort. Package: 175cc HDPE Bottle. Type: Vegetable Capsule Count: 60, Dose: 2 Capsules. Product Sku: PB173.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2026·2025-11-19

    Reprocessed vessel sealers recalled over residual material that may dislodge

    Medline is recalling 57,244 reprocessed LigaSure Maryland Jaw sealer/dividers because certain areas of the device can trap residual material that may, in rare cases, become dislodged.

    Product
    Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0173-2026·2025-11-19

    Artisan English muffins recalled over an undeclared milk allergen

    Blue Oven Bakery is recalling about 4,500 bags of Blue Oven Artisan Bakery English Muffins sold in Indiana, Kentucky and Ohio over undeclared milk.

    Product
    Blue Oven Artisan Bakery English Muffins, Net Wt. 13.4 oz (380g), packaged as a 4-pack in a clear plastic bag, UPC 198715684322
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0457-2026·2025-11-19

    Monitor batteries recalled because they can lose the ability to charge

    GE Healthcare is recalling 2,857 FLEX-3S2P lithium-ion batteries used with patient monitors because they can lose the capability to hold charge and provide backup power.

    Product
    BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2026·2025-11-19

    Nasal feeding tubes recalled from one lot because they may be occluded

    Applied Medical Technology is recalling NutraGlide 5 F-6 F x 55 nasal feeding tubes with stylet and ENfit from one lot because the tube may be occluded.

    Product
    Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-N-I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0493-2026·2025-11-19

    Food allergen panels recalled over barcodes causing wrong tube scanning order

    Siemens Healthcare Diagnostics is recalling 28 units of Food Panel 3 Specific Allergen because barcode orientation causes the instrument to misread tube positions in the holder wedge.

    Product
    Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0497-2026·2025-11-19

    Larger bore nasal feeding tubes recalled for possible occlusion

    Applied Medical Technology is recalling NutraGlide 6 F-8 F x 55 nasal feeding tubes with stylet and ENfit from one lot because the tube may be occluded.

    Product
    Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2026·2025-11-19

    Hematology analyzers recalled because saturation flags may not be applied

    Abbott Laboratories is recalling 833 Alinity hq Analyzers because a software issue means the system does not visibly flag results when saturation is present, which may give incorrect results.

    Product
    Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0501-2026·2025-11-19

    Positive control serum recalled over negative recovery of the HBsAg analyte

    Techno-Path is recalling 76 units of Multichem ID-B positive control serum because of potential negative recovery of the HBsAg analyte on the Alinity i platform.

    Product
    Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen…
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0453-2026·2025-11-19

    Patient monitors recalled over batteries that can lose backup power

    GE Healthcare is recalling 3,271 Carescape B450 patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.

    Product
    Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 to include: CARESCAPE B450 MBA313 2095800-001 CARESCAPE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2026·2025-11-19

    Fifteen millimetre snares recalled over holes compromising package sterility

    Olympus is recalling 18,174 Single Use Electrosurgical Snares SD-400U-15 because sterility may be compromised by small holes formed during packaging or transportation.

    Product
    Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0494-2026·2025-11-19

    Nasal feeding tubes recalled from a second lot for possible occlusion

    Applied Medical Technology is recalling NutraGlide 5 F-6 F x 55 nasal feeding tubes with stylet and ENfit, REF NFT-05055-I, from one lot because the tube may be occluded.

    Product
    Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0482-2026·2025-11-19

    Electrosurgical snares recalled over small holes compromising package sterility

    Olympus is recalling 48,208 Single Use Electrosurgical Snares SD-400 because sterility may be compromised by small holes formed during packaging or transportation.

    Product
    Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2026·2025-11-19

    Lithotripsy transducers recalled over startup failures and handpiece temperature rise

    Olympus is recalling 1,528 ShockPulse Lithotripsy Transducers because the device may fail to start or stop shortly after starting, and the handpiece body may heat up during clinical use.

    Product
    Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2026·2025-11-19

    Blunt tip sealers recalled over residual material trapped inside the device

    Medline is recalling 60,917 reprocessed LigaSure Blunt Tip sealer/dividers, 37 cm, because certain areas of the device can trap residual material that may become dislodged.

    Product
    Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2026·2025-11-19

    Spinal cord stimulators recalled over loss of programmer communication

    Abbott Medical is recalling 20,715 Eterna spinal cord stimulation implantable pulse generators because the devices may lose communication with the clinician programmer or patient controller.

    Product
    Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0485-2026·2025-11-19

    Surgical staplers recalled over a malformed cover tube press

    Covidien is recalling 3,263 Signia Small Diameter Curved Tip Intelligent Reloads because a manufacturing issue can allow internal components to move during firing, risking uncontrolled motion.

    Product
    Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0481-2026·2025-11-19

    Oxygen concentrator batteries recalled over a chip that can stop oxygen

    Philips Respironics is recalling 56 SimplyGo Mini standard battery kits because a defective chip can make the battery fail, shutting down the concentrator and stopping oxygen delivery.

    Product
    SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2026·2025-11-19

    Portrait vital signs monitors recalled over batteries losing backup power

    GE Healthcare is recalling 5,990 Portrait VSM patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.

    Product
    Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0181-2026·2025-11-19

    Nutra Calm supplement recalled because it contains magnesium salicylate

    Professional Botanicals is recalling 452 bottles of Nutra Calm capsules because the product contains magnesium salicylate.

    Product
    Product Name: Nutra Calm Package: 175cc HDPE Bottle. Type: Vegetable Capsule Count: 90, Dose: 2 Capsules. Product Sku: PB248
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2026·2025-11-19

    Blunt tip sealers 44 cm recalled over trapped residual material

    Medline is recalling 1,446 reprocessed LigaSure Blunt Tip sealer/dividers, 44 cm, because certain areas of the device can trap residual material that may become dislodged.

    Product
    Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2026·2025-11-19

    Reprocessed ultrasonic shears recalled because they may stick in the on position

    Stryker Sustainability Solutions is recalling 22,476 reprocessed HARMONIC FOCUS shears because a manufacturing issue may leave them stuck in the on position, causing continuous activation.

    Product
    HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0496-2026·2025-11-19

    Ninety centimetre nasal feeding tubes recalled for possible occlusion

    Applied Medical Technology is recalling NutraGlide 5 F-6 F x 90 nasal feeding tubes with stylet and ENfit from one lot because the tube may be occluded.

    Product
    Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05090-I
    Category
    Medical Device
    Distribution
    Distributed nationwide