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.

2851–2875 of 88106

  • ModerateFDA (Devices)·Z-1953-2026·2026-05-06

    Philips Achieva 3.0T MR Elastography system stiffness value error recall

    Philips is recalling the Achieva 3.0T with MR Elastography system due to potential stiffness value errors in image reconstruction when specific parameters are used, which may cause incorrect voxel size display in the default scan protocol.

    Product
    Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0506-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recall Due to cGMP Deviations

    Wells Pharma of Houston is recalling fentanyl citrate injectable solution (1000 mcg/50 mL) due to current good manufacturing practice (cGMP) deviations. The recall affects 150 syringes distributed nationwide.

    Product
    fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1980-2026·2026-05-06

    Dimension Creatinine Flex Reagent Cartridge Recalled for Imprecision Results

    Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridges due to potential imprecision in creatinine test results that could be erroneously increased or decreased.

    Product
    Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1965-2026·2026-05-06

    Philips SmartPath to dStream MR Elastography System Reconstruction Error

    Philips is recalling certain SmartPath to dStream 1.5T MR Elastography systems due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause incorrect voxel size settings in the default MRE scan protocol.

    Product
    Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2003-2026·2026-05-06

    Philips Bridge Prep Kit catheter may experience resistance during advancement

    Merit Medical Systems is recalling the Philips Bridge Prep Kit (REF K12-09098C) because the catheter may experience resistance when advanced over the guidewire, potentially affecting proper device function.

    Product
    Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1962-2026·2026-05-06

    Philips Ingenia Elition S MRI stiffness value error correction

    Philips Ingenia Elition S MRI systems with MR Elastography may display incorrect voxel size settings in the default scan protocol when certain image reconstruction parameters are used, potentially leading to stiffness value errors.

    Product
    Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1982-2026·2026-05-06

    BD GasPak EZ CO2 Pouch System gas generating sachets underperforming

    Becton Dickinson is recalling certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification.

    Product
    BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1986-2026·2026-05-06

    Depuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Compromise

    Depuy Synthes is recalling ATTUNE Revision Hinge Femoral components because external sterile packaging was found adhered to internal sterile packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1963-2026·2026-05-06

    Philips Ingenia Elition X MRI Scanner Recall for Image Reconstruction Error

    Philips is recalling Ingenia Elition X MRI scanners with MR Elastography due to potential errors in stiffness value measurements when specific image reconstruction parameters are used, which may cause incorrect voxel size display in the default scan protocol.

    Product
    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1961-2026·2026-05-06

    Philips Ingenia Ambition X MRI Systems Stiffness Value Error Recall

    Philips Ingenia Ambition X MRI systems with MR Elastography may produce incorrect stiffness values due to image reconstruction parameter errors, affecting diagnostic accuracy.

    Product
    Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0500-2026·2026-05-06

    iVIZIA Dry Eye Lubricant Drops Recalled for Sterility Assurance

    Thea Pharma, Inc. is recalling iVIZIA Dry Eye (Povidone 0.5%) lubricant eye drops nationwide due to the FDA's discovery of manufacturing process deviations that affect the product's sterility assurance.

    Product
    IVIZIA DRY EYE — IVIZIA DRY EYE (POVIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0679-2026·2026-05-06

    Negita shrimp crackers contain undeclared FD&C Yellow 6

    Negita Cracker Shrimp 2.8 oz is being recalled because the product contains undeclared FD&C Yellow 6. 142 units are affected.

    Product
    Negita Cracker- Shrimp 2.8oz
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1988-2026·2026-05-06

    DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall

    DePuy Synthes is recalling 3 units of ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM due to external sterile packaging adhered to internal packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0678-2026·2026-05-06

    52USA mango popping boba contains unapproved color additives

    52USA brand Popping Boba in mango flavour is being recalled because it contains unapproved colors: tartrazine, sunset yellow and allura red. 5,196 units are affected.

    Product
    52USA brand POPPING BOBA; MANGO FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407)…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0504-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations

    Wells Pharma of Houston is voluntarily recalling 2,940 IV bags of fentanyl citrate injectable solution due to cGMP (current good manufacturing practice) deviations. The product was distributed nationwide.

    Product
    fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0503-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations

    Wells Pharma is recalling fentanyl citrate injectable solution (1000 mcg/100 mL, 10 mcg per mL) distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 4,030 IV bags with various lot numbers and expiration dates between April and June 2026.

    Product
    fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1967-2026·2026-05-06

    Philips SmartPath to dStream MR Elastography Software Parameter Error

    Philips is recalling specific units of SmartPath to dStream for XR and 3.0T with MR Elastography due to potential stiffness value errors when certain image reconstruction parameters are used with Resoundant's algorithm, which may cause voxel size settings in the default MRE scan protocol to display incorrectly.

    Product
    Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1968-2026·2026-05-06

    Philips SmartPath to Ingenia Elition X MR Elastography Stiffness Value Errors

    Philips is recalling three models of SmartPath to Ingenia Elition X with MR Elastography devices due to potential stiffness value errors when specific image reconstruction parameters are combined with Resoundant's algorithm.

    Product
    Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1964-2026·2026-05-06

    Philips MR 7700 MR Elastography device stiffness value error recall

    Philips is recalling certain MR 7700 devices with MR Elastography due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause voxel size settings to display incorrectly.

    Product
    Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0507-2026·2026-05-06

    Ketamine Hydrochloride Injectable Solution Recalled for cGMP Deviations

    Wells Pharma of Houston LLC is recalling 4,975 syringes of Ketamine Hydrochloride Injectable Solution (50 mg/mL) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1952-2026·2026-05-06

    Philips Achieva 1.5T MRI System MRE Protocol Parameter Error Recall

    Philips Achieva 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings when certain image reconstruction parameters are used together, potentially affecting diagnostic accuracy.

    Product
    Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2008-2026·2026-05-06

    Medline Neuro Sponges recalled for out-of-specification endotoxin levels

    Medline Industries is recalling Medline Neuro Sponges in multiple sizes worldwide after internal review found higher-than-expected endotoxin levels in representative product samples.

    Product
    Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02; 2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 0.5", XR, 10/PK, Medline SKU NEUROSPNG05; 3.…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1949-2026·2026-05-06

    Genius Review Station Display Modified Outside Validated Configuration

    Hologic is correcting Genius Review Station displays (model CMP-01669) that were modified by users outside the FDA-cleared configuration. The devices need restoration to validated settings per the manufacturer's Operator's Manual.

    Product
    Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1946-2026·2026-05-06

    Disposable Mixing Bowls with Spatula recalled for compromised sterile barrier

    Zimmer, Inc. is recalling Disposable Mixing Bowls with Spatula (Model 00-5049-011-00) due to package seal defects that may compromise the sterile barrier. Ten complaints have been received identifying incomplete seals, wrinkles, or peeling seals.

    Product
    Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0505-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations

    Wells Pharma of Houston LLC has recalled fentanyl citrate injectable solution (1250 mcg/25mL) distributed nationwide due to cGMP deviations. The recall involves 50 syringes from Lot 011226204250063, expiring 05/14/2026.

    Product
    fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
    Category
    Drug
    Distribution
    Distributed nationwide