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.

6976–7000 of 88183

  • ModerateFDA (Devices)·Z-2196-2025·2025-08-06

    IontoPatch STAT nonwoven pads do not absorb the saline solution

    IontoPatch STAT On-the-Go Patch Therapy is being recalled because the nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with it. 80,928 units affected.

    Product
    IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2172-2025·2025-08-06

    Sterilizable Drill Stop Kits were shipped containing incorrect components

    The Drill Stop Kit, a version of the Mini Sterilizable Tray used to store, sterilize and verify drill stop length, is being recalled because it contains incorrect components. 45 kits affected.

    Product
    The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0338-2025·2025-08-06

    Suspiros tres leches cajeta cake contains goat milk labeled as milk

    Suspiros Tres Leches Cajeta Cake is being recalled because it contains goat milk, which was labeled simply as "milk". 1,249 units are affected.

    Product
    Suspiros Tres Leches Cajeta Cake. 15 P: 25 servings (2500 gr), 4P: 7 servings (700gr), Pocket: 3.7 servings (370gr). UPC= 15P: 1335, 4P: 6982, POCKET: 35256. Type of packaging: Plastic dome and plate (15P and 4P) and Blister plastic tray with lid (in Pocket presentation). Firm…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2191-2025·2025-08-06

    BostonSight PROSE lenses made with sagittal height or haptic errors

    BostonSight PROSE Lenses are being recalled because select orders were manufactured with errors impacting sagittal height, haptics, or both. 38 units are affected.

    Product
    BostonSight PROSE Lens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0542-2025·2025-08-06

    Amlodipine and benazepril capsules released with the wrong expiry date

    Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg are being recalled because they were released with the wrong expiry date, printed as February 2027 instead of January 2027. 7,668 bottles affected.

    Product
    AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0543-2025·2025-08-06

    Timolol eye drop caps can lodge a spike in the nozzle

    Timolol Maleate Ophthalmic Solution USP 0.5% is being recalled because of a defective container: the spike of the cap becomes lodged in the nozzle of the bottle. 154,176 bottles affected.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2192-2025·2025-08-06

    Phasor neurosurgical drills may have a reverse battery orientation

    The Phasor Drill, used in neurosurgical procedures, is being recalled because it may have a reverse battery orientation, which may increase surgical time. 1,064 units are affected.

    Product
    Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-2219-2025·2025-08-06

    ASPIRE Cristalle mammography systems shipped with unapproved slabbing software enabled

    ASPIRE Cristalle Mammography Systems with the Digital Breast Tomosynthesis option are being recalled because devices had an unapproved slabbing software function enabled for use. 293 units affected.

    Product
    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0345-2025·2025-08-06

    Suspiros German cake contains goat milk labeled only as milk

    Suspiros German Cake is being recalled because it contains goat milk, which was labeled simply as "milk". 93 units are affected.

    Product
    Suspiros German Cake. 15 P: 37.5 servings (2062 gr), 4P: 10 servings (550gr). UPC= 15 P: 1342, 4P: 6971. Type of packaging: Plastic dome and plate (15P and 4P). Firm name: NOVACAB SAPI de CV. Address listed on label: El paso, TX 79901, USA.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0547-2025·2025-08-06

    Sucralfate tablets recalled because bankruptcy left the quality program unmonitored

    Sucralfate Tablets USP 1 gram from Nostrum Laboratories are being recalled across all lots within expiry because the firm cannot monitor its quality program after filing for Chapter 11. 60,608 bottles affected.

    Product
    Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0381-2025·2025-08-06

    Pure Monk Fruit Sweetener bottles actually contain mislabeled stevia powder

    Pure Monk Fruit Sweetener, 0.71 oz, is being recalled because the product is stevia powder but the bottle was mislabeled as Pure Monk Fruit Sweetener. 78 bottles are affected.

    Product
    Pure Monk Fruit Sweetener, net wt. 0.71oz. UPC 7 39223 00187 6. Product is packaged in a plastic bottle with white cap. Ingredient: Monk Fruit (Luo Han Guo) Extract. Monk Fruit is so much sweeter than sugar, a pinch is all you need. Suggested Use: Add to sweeten your food or…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0341-2025·2025-08-06

    Suspiros four leches cake contains goat milk labeled only as milk

    Suspiros 4 Leches Cake is being recalled because it contains goat milk, which was labeled simply as "milk". 612 units are affected.

    Product
    Suspiros 4 Leches Cake. 15 P: 26 servings (2600 gr), 4P: 7 servings (700 gr), Pocket: 4.1 servings (410gr). UPC=15P: 1343, 4P: 6969, POCKET: 7904. Type of packaging: Plastic dome and plate (15P and 4P) and Blister plastic tray with lid (in Pocket presentation). Firm name…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·H-0337-2025·2025-07-30

    Needle mushrooms from China tested positive for Listeria monocytogenes

    Needle Mushrooms in 200 gram packages, a product of China, are being recalled because the product tested positive for Listeria monocytogenes. 80 cases are affected.

    Product
    Needle Mushrooms, Product of China, 200 gram packages, Plastic clear packaging on top with blue on the bottom (non-transparent). 25 packages per box .
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·H-0322-2025·2025-07-30

    SunBiotics probiotic chocolate covered almonds tested positive for Salmonella

    SunBiotics Activated Almonds Infused with Probiotics, Oat Milk Chocolate, are being recalled after the firm detected Salmonella on one batch. 196 units are affected.

    Product
    SunBiotics Activated Almonds Infused with Probiotics, Oat Milk Chocolate, NET WT. 1 oz(28g) packaged in cases.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2165-2025·2025-07-30

    Biofinity XR Toric contact lens blisters may have a leaking seal

    Biofinity XR Toric Contact Lenses are being recalled because lens blisters may have an incomplete or leaking seal, which may render them unsterile. 397 units are affected.

    Product
    Biofinity XR Toric Contact Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2025·2025-07-30

    Nellcor bedside SpO2 monitor alarms may not be heard or recognized

    The Covidien Nellcor Bedside SpO2 Patient Monitoring System is being recalled because alarms may not be heard or recognized, which the manufacturer links to treatment delay. 264,790 units are affected.

    Product
    Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0308-2025·2025-07-30

    Turkeyfoot Creek Creamery Avalanche ice cream has undeclared soy and wheat

    Turkeyfoot Creek Creamery Avalanche Artisan Ice Cream in one pint cartons is being recalled because of undeclared soy and wheat. All expiration dates are affected.

    Product
    Turkeyfoot Creek Creamery Avalanche Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2147-2025·2025-07-30

    EMPOWR dual mobility poly bearings were packaged with the wrong implant

    EMPOWR Acetabular Dual Mobility Poly Bearings are being recalled because of a packaging discrepancy in which incorrect implants were packaged, discovered through a customer complaint. 20 units affected.

    Product
    Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2148-2025·2025-07-30

    EMPOWR dual mobility OD42 bearings were packaged with the wrong implant

    EMPOWR Acetabular Dual Mobility Poly Bearings, catalog number 952-28-42F, are being recalled because of a packaging discrepancy in which incorrect implants were packaged. 20 units affected.

    Product
    Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2171-2025·2025-07-30

    Stryker StrykeFlow irrigator with tip may leak solution into handpiece

    The Stryker StrykeFlow Disposable Suction/Irrigator with Disposable Tip is being recalled because irrigation solution may leak into the handpiece and battery pack, causing it to malfunction.

    Product
    Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2025·2025-07-30

    Natus brain monitor breakout box shows right side impedance under left

    The Natus Brain Monitor Breakout Box is being recalled after two complaints that the left side labeling showed impedance for the right side. 27 units are affected.

    Product
    Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2169-2025·2025-07-30

    CareLink SmartSync limited the window to abort a high voltage therapy

    Medtronic CareLink SmartSync Device Manager is being updated because in prior application versions the abort window during an induction test limited the user's ability to cancel high voltage therapy. 22,091 devices affected.

    Product
    Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2025·2025-07-30

    SIGNA Architect AIR gradient coils can produce acoustic noise above limit

    GE HealthCare SIGNA Architect AIR MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.

    Product
    SIGNA Architect AIR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2025·2025-07-30

    Azurion 7 M20 C-arm gearbox mounting bolts may become loose

    The Azurion 7 M20 fluoroscopic x-ray system is being recalled because of the potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. 78 units affected.

    Product
    Azurion 7 M20. Fluoroscopic X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide