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 →

151–175 of 633

  • HighFDA (Devices)·Z-2187-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recall Due to Incomplete Sterile Seals

    Stryker Sustainability Solutions is recalling 108 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging. The defect may compromise sterility assurance.

    Product
    Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2176-2026·2026-05-20

    Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals

    Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable reprocessed electrophysiology catheters (Product Number 200344) due to incomplete seals on sterile product packaging that could compromise sterility.

    Product
    BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2026·2026-05-20

    Medtronic SynchroMed Flex Infusion Programmer Software Application

    Medtronic SynchroMed Flex Infusion Mode A810 Clinician Programmer Software may display infusion steps out of order, preventing medication from being delivered at the intended time. Affected devices are clinician programmer tablets worldwide.

    Product
    Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2169-2026·2026-05-20

    QuickVue Dipstick Strep A Test Recalled for False Positive Results

    Quidel Corporation is recalling the QuickVue Dipstick Strep A Test (50T, REF 20108) due to the potential for false positive results. The product was distributed nationwide.

    Product
    QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0769-2026·2026-05-20

    Dakota Honey Company Spreadable Spun Honey Cinnamon-Infused Recall

    Dakota Honey Company is recalling Spreadable Spun Honey, Cinnamon-Infused, in 4 oz and 12 oz jars due to potential foreign objects including stainless steel dust, flakes, or plastic shreds. Consumers should stop using affected jars purchased during the specified timeframes.

    Product
    Dakota Honey Company Spreadable Spun Honey, Cinnamon-Infused. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60012-41980 7. 2. Net Wt 12 oz (340g) UPC 8 60010-57963 3.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2026·2026-05-20

    [pending] Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App

    Pending LLM rewrite. Source: FDA_DEVICE Z-2164-2026.

    Product
    Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS ph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2188-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Daig Livewire Steerable recalled

    Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product. The recall affects 19 units distributed nationwide in the US, Israel, and Canada.

    Product
    Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0779-2026·2026-05-20

    Prospector Popcorn Belgian Chocolate Toffee popcorn recalled for undeclared soy

    Prospector Popcorn brand Belgian Chocolate Toffee flavored popcorn is being recalled because it contains undeclared soy lecithin, which poses a risk to consumers with soy allergies.

    Product
    Prospector Popcorn brand Belgian Chocolate Toffee flavored popcorn; Ingredients: Non-GMO popcorn, brown sugar, corn syrup, butter, vanilla, baking soda, sea salt, white chocolate (sugar, palm kernel fat, skimmed milk powder [12%], emulsifier [lecithins], natural vanilla flavoring
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2199-2026·2026-05-20

    Reprocessed Medtronic Marinr Steerable Electrophysiology Catheter Recall

    Stryker Sustainability Solutions is recalling 87 units of the Medtronic Marinr Steerable reprocessed electrophysiology catheter (Product Number 72402) due to incomplete seals on the sterile product.

    Product
    Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0768-2026·2026-05-20

    Dakota Honey Company Spreadable Spun Honey Recalled for Foreign Objects

    Dakota Honey Company is recalling Spreadable Spun Honey (Original) because containers may contain stainless steel dust, flakes, or shreds of plastic.

    Product
    Dakota Honey Company Spreadable Spun Honey, Original. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60010-57969 5. 2. Net Wt 12 oz (340g) UPC 8 60010-57961 9.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2177-2026·2026-05-20

    BARD Dynamic Tip Steerable Medical Device Recall Due to Incomplete Seals

    Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable devices due to incomplete seals on the sterile product. The recall affects 427 units distributed nationwide and in Israel and Canada.

    Product
    BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals

    Stryker Sustainability Solutions is recalling BARD Dynamic Deca Steerable reprocessed electrophysiology catheters (Product Number 201101) distributed nationwide and in Israel and Canada due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility.

    Product
    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2026·2026-05-20

    Daig Livewire Steerable Electrophysiology Catheter Incomplete Seals Recall

    Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters (Product Number 401904) due to incomplete seals on sterile product. The recall affects 1,352 units distributed across the United States, Israel, and Canada.

    Product
    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2197-2026·2026-05-20

    Daig Livewire Steerable Reprocessed Electrophysiology Catheter Recall

    Stryker Sustainability Solutions is recalling 458 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.

    Product
    Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2026·2026-05-20

    Daig Livewire Steerable Electrophysiology Catheter Sterile Seal Defect Recall

    Stryker Sustainability Solutions is recalling three lots of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile packaging. The defect affects units distributed in the US, Israel, and Canada.

    Product
    Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2190-2026·2026-05-20

    Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals

    Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging, which may compromise sterility.

    Product
    Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2135-2026·2026-05-20

    DonJoy IceMan CLASSIC3 Cold Therapy Unit Connector Defect

    DJO, LLC is recalling the DONJOY IceMan CLASSIC3 cold therapy unit (Model 11-1422) due to a broken connector that may interrupt prescribed cold therapy treatment.

    Product
    Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2153-2026·2026-05-20

    Revolution CT ES X-ray Computed Tomography System Security Vulnerability Recall

    GE Medical Systems is recalling Revolution CT ES and related CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link based CT Smart Subscription. The vulnerability may affect system security.

    Product
    Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2171-2026·2026-05-20

    ZYMUTEST HIA IgG ELISA Diagnostic Kit Recall for Incorrect Control Values

    Aniara Diagnostica LLC is recalling ZYMUTEST HIA IgG diagnostic kits (Lot FD1265) due to an outdated flyer containing incorrect positive control values that could affect test result interpretation.

    Product
    ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2137-2026·2026-05-20

    DonJoy IceMan cold therapy unit recall due to broken connector

    DJO, LLC is recalling the DonJoy IceMan CLASSIC3 cold therapy unit (model 11-9099) due to a broken connector that may interrupt prescribed cold therapy. The affected unit is lot 110525, distributed across the US and Canada.

    Product
    Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2155-2026·2026-05-20

    Revolution Apex Select CT systems subject to software security vulnerability recall

    GE HealthCare is recalling Revolution Apex Select and related CT systems due to a security vulnerability in the AW Server software deployed via Edison Health Link-based CT Smart Subscription.

    Product
    Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2134-2026·2026-05-20

    DonJoy IceMan Classic Cube cold therapy unit connector defect recall

    DJO, LLC is recalling DONJOY ICEMAN CLASSIC CUBE cold therapy units due to broken connectors that may interrupt prescribed cold therapy. Approximately 596 units were distributed nationwide and in Canada.

    Product
    Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps pro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0547-2026·2026-05-20

    Metoprolol Succinate Extended-Release Tablets Recalled Due to Failed Dissolution

    Ascend Laboratories is recalling 17,304 bottles of Metoprolol Succinate Extended-Release 25 mg tablets (Lot #25140859, expiring Jan 2027) distributed nationwide because the tablets failed dissolution specifications, which may affect drug effectiveness.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2172-2026·2026-05-20

    Edwards EVOQUE Tricuspid Delivery System Labeling Update for Valve Functionality

    Edwards Lifesciences is updating labeling for the Edwards EVOQUE tricuspid delivery system (REF 9850TDS) to provide a warning if valve replacement delivery system functionality becomes compromised.

    Product
    Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
    Category
    Medical Device
    Distribution
    Distributed nationwide