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.

12651–12675 of 27206

  • HighFDA (Devices)·Z-1072-2024·2024-02-21

    Philips ProxiDiagnost N90 X-ray System Recall for Patient Data and Security Issues

    Philips is recalling 138 U.S. units of its ProxiDiagnost N90 radiography system due to two identified issues. The system may display incorrect patient images during scan transitions, and a security vulnerability could allow unauthorized data access with physical device access.

    Product
    ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1067-2024·2024-02-21

    Bone void filler recalled due to manufacturing process control issue

    Musculoskeletal Transplant Foundation recalled 50 units of AFT Allograft Filler Tubes in Minnesota due to an unqualified manufacturing filling process. The product may have extrudability issues causing extended surgery time.

    Product
    AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1140-2024·2024-02-21

    FilmArray GI diagnostic kits recalled due to false positive Norovirus results

    BioFire Diagnostics is recalling FilmArray GI diagnostic test kits due to potential signals of increased false positive Norovirus results. Approximately 64,594 kits representing 2.3 million tests have been distributed worldwide.

    Product
    FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1074-2024·2024-02-21

    Impella Catheters: Warnings Added for Potential Fiber Ingestion Risk

    Abiomed is adding safety warnings to Instructions for Use for all Impella catheter models to prevent fibers from entering the device, which could result in reduced flow. The warning applies to all Impella models distributed worldwide.

    Product
    Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2024·2024-02-21

    Medical Device Control Panel Contaminated with Norovirus, Causes False Positive Results

    Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet) negative control is contaminated with Norovirus. Users testing this control will incorrectly receive positive Norovirus results.

    Product
    Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2024·2024-02-21

    Portable X-ray system may move unexpectedly if improperly cleaned

    The MobileDiagnost wDR portable X-ray system may move unexpectedly if excessive liquid is used during cleaning. This affects 851 devices distributed nationwide.

    Product
    MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0872-2024·2024-02-21

    Woodstock 5 Grain Cereal recalled for undisclosed wheat allergen

    Woodstock 5 Grain Cereal is recalled because triticale, a product ingredient, is not identified as wheat on the label. This creates a risk for people with wheat allergies.

    Product
    Woodstock 5 Grain Cereal. Oats, Rye, Triticale, Barley, Golden Flax. Net Wt. 18.5 oz (1 lb 2.5 oz) 524g. UPC 0 42563-01772 9. Distributed by Woodstock, 313 Iron Horse Way, Providence, RI 02908. Packaged in a plant that also processes wheat.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1076-2024·2024-02-21

    FDA Recalls Heart-Lung Machine Component Over Sterile Barrier Defect

    Maquet is recalling an HLS Set Advanced 5.0 component used in CARDIOHELP heart-lung machines due to a compromised sterile barrier that may cause infection. The recall affects 6,657 US units.

    Product
    Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2024·2024-02-21

    Philips CombiDiagnost R90 Fluoroscopy Device May Display Wrong Patient Images

    The Philips CombiDiagnost R90 fluoroscopy device may display a previous patient's radiography images during an examination, risking privacy violation and diagnostic errors in 86 affected units.

    Product
    CombiDiagnost R90 1.0 (709030)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2024·2024-02-21

    HeartSine Samaritan PAD Defibrillators Recalled for Test Configuration Flaw

    HeartSine samaritan PAD defibrillators shipped in test configuration may have incorrect CPR timing and delayed or no therapy delivery in cardiac events. Users should stop using affected units and contact the manufacturer.

    Product
    HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0873-2024·2024-02-21

    Gluten Free Bean and Cheese Burrito recalled for plastic contamination

    Amy's Kitchen is recalling Gluten Free Bean and Cheese Burritos (5.5 oz) due to the possible presence of plastic material in the product. The recall affects lot #30K0823 with best before date November 2025.

    Product
    Gluten Free Bean and Cheese Burrito (5.5 oz), individual plastic overwrap, 12 retail units/case, frozen
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-0322-2024·2024-02-21

    Nortrel 7/7/7 Oral Contraceptive Recalled for Discolored Tablets

    Teva Pharmaceuticals is recalling Nortrel 7/7/7 oral contraceptive tablets due to a manufacturing defect: discolored blue tablets mixed with white inert tablets. This could cause confusion about which tablets to take in the triphasic regimen.

    Product
    NORTREL 7/7/7 — NORTREL 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1084-2024·2024-02-21

    Stryker Neurovascular Trevo Pro Microcatheter Recalled for Unevaluated Use Statement

    Stryker is recalling the Trevo Pro 18 Microcatheter because its instruction manual contains an intended use that the FDA has not evaluated. The recall affects 11 units distributed across the United States.

    Product
    Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0324-2024·2024-02-21

    HydrALAZINE Hydrochloride Tablets Recalled for Out-of-Specification Impurities

    HydrALAZINE Hydrochloride Tablets Lot T04680 are recalled for out-of-specification impurities found during routine testing. No illnesses have been reported, but the product poses a remote risk of reversible effects.

    Product
    HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1086-2024·2024-02-21

    Quidel Sofia 2 Flu + SARS Test Kits Recalled for Incorrect Expiration Dates

    Quidel Corporation is recalling one lot of Sofia 2 Flu + SARS Antigen FIA diagnostic test kits due to incorrect expiration dates on packaging. Kits labeled to expire April 30 and May 31, 2025 actually expire September 12, 2024.

    Product
    The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0321-2024·2024-02-21

    Nortrel Oral Contraceptive Tablets Recalled for Discolored Inert Remainder Tablets

    Teva Pharmaceuticals is recalling 12,916 cartons of Nortrel oral contraceptive tablets nationwide due to discolored inert remainder tablets that may cause confusion. Affected lot: #100042978, expiration 7/31/2024.

    Product
    NORTREL — NORTREL (NORETHINDRONE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0308-2024·2024-02-14

    FDA Class I Drug Recall: Non-Sterile Multi-Action Relief Drops

    Rite Aid is recalling Multi-Action Relief Drops nationwide due to non-sterility concerns. The FDA classified this as a Class I recall affecting 9,216 bottles.

    Product
    Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0293-2024·2024-02-14

    FDA recalls Rugby brand lubricating eye drops nationwide for non-sterility

    Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops are being recalled nationwide due to non-sterility. The recall affects all lots of the 0.5 FL OZ bottles distributed.

    Product
    Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0299-2024·2024-02-14

    Drug recall: DRY EYE RELIEF eye drops for non-sterility

    FDA recalls DRY EYE RELIEF eye drops nationwide due to non-sterility. The ophthalmic product distributed in 23,208 bottles affects all lots. Consumers should discontinue use immediately.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0298-2024·2024-02-14

    Drug: CVS Health Lubricant Gel Drops recalled nationwide for non-sterility

    CVS Health Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) are being recalled nationwide due to non-sterility concerns. All lots of the product in single and twin pack bottles are affected.

    Product
    CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0303-2024·2024-02-14

    FDA recalls non-sterile EQUATE lubricant eye drops nationwide

    Walmart's EQUATE brand Hydration PF Lubricant Eye Drops are being recalled due to non-sterility. This FDA Class I recall affects 33,984 bottles distributed nationwide.

    Product
    EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0857-2024·2024-02-14

    Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes

    Cardinal Health is recalling all sizes of Monoject sterile syringes—including Luer-Lock and Enteral syringes with ENFit connections—due to manufacturing and rebranding changes. Products distributed across the U.S. and Canada.

    Product
    Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0855-2024·2024-02-14

    Cardinal Health Monoject Syringe and Enteral Syringe Removal Due to Manufacturing Changes

    Cardinal Health is removing Monoject sterile syringes (Luer-Lock and Enteral with ENFit) from the market due to manufacturing and rebranding changes. Distribution affected US and Canada.

    Product
    Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0305-2024·2024-02-14

    FDA Recalls CVS Health Lubricating Eye Drops Due to Non-Sterility

    CVS Health brand Lubricating Eye Drops are being recalled due to non-sterility. The FDA Class I recall affects 45,408 bottles distributed nationwide.

    Product
    CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-711-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0856-2024·2024-02-14

    Cardinal Health Monoject sterile syringes recalled due to manufacturing changes

    Cardinal Health is recalling all sizes of its Monoject sterile syringes (Luer-Lock and ENFit models) nationwide due to manufacturing and rebranding changes. The FDA classified this as a Class I recall.

    Product
    Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777
    Category
    Medical Device
    Distribution
    Distributed nationwide