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.

8151–8175 of 88183

  • 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…
    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-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 (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-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-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 (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…
    Category
    Drug
    Distribution
    2 states
  • 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-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-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 (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 (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…
    Category
    Medical Device
    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-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 (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 (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 (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 (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-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
  • 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-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-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-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-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-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