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.

9051–9075 of 88183

  • HighFDA (Devices)·Z-1170-2025·2025-02-19

    Hologic Sertera-14 Biopsy Device Recalled for Inner Needle Separation Risk

    Hologic is recalling 55,335 Sertera-14 biopsy devices nationwide because the inner needle can separate from the hub, creating a risk of needle dislodgement during use.

    Product
    Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0538-2025·2025-02-19

    Chocolate Banana Granola Bars Recalled for Potential Metal Contamination

    Riverside Natural Foods is recalling Chocolate Banana Granola Bars sold nationwide due to potential metal contamination. Consumers should not eat affected products and should consult a healthcare provider if consumed.

    Product
    1. Chocolate Banana Granola Bars; 5.1oz (6 bars) 2. Chocolate Banana Granola Bars; 0.85oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2025·2025-02-19

    Exactech Alteon XLE Hip Replacement Liners Recalled for Missing Barrier Layer

    Exactech is recalling Alteon XLE hip replacement liners due to a manufacturing defect. Some units lack the Ethylene Vinyl Alcohol barrier layer required for proper device function.

    Product
    Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL…
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1131-2025·2025-02-19

    Cardinal Health Laryngoscopy Packs Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource Kits containing laryngoscopy packs are being recalled due to potential endotoxin contamination in non-sterile surgical strips and patties.

    Product
    Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2025·2025-02-19

    Cardinal Health Presource surgical kits recalled for endotoxin contamination risk

    Cardinal Health is recalling Presource Kits for potential endotoxin contamination in non-sterile surgical strips and patties. These surgical components could pose infection risks if used in procedures.

    Product
    Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0542-2025·2025-02-19

    Halloween Chocolate Chip Granola Mini Bars recalled for possible metal contamination

    Riverside Natural Foods is recalling Halloween Chocolate Chip Granola Mini Bars distributed nationwide due to possible metal pieces. Consumers should not eat these products.

    Product
    1. Halloween Chocolate Chip Granola Mini Bars 12.6oz (30 bars) 2. Halloween Chocolate Chip Granola Mini Bars 0.42oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0547-2025·2025-02-19

    Made Good Variety Pack recalled for potential metal contamination nationwide

    Riverside Natural Foods is recalling Made Good Variety Pack products nationwide due to potential metal contamination. Consumers should not consume the products and return them to retailers.

    Product
    1. Made Good Variety Pack 37ct 2.MadeGood Variety Pack 7ct
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1140-2025·2025-02-19

    Cardiac Diagnostic Implant Recalled for Premature Device Failure

    Angel Medical Systems is recalling The Guardian cardiac diagnostic implants due to devices reaching end of service prematurely. The affected units may fail to properly detect acute coronary syndrome events.

    Product
    Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0563-2025·2025-02-19

    Cheese powder ingredient blend recalled for plastic thread contamination

    Bridgewell Agribusiness recalls 5912MOD-CAU Pre-Blend (lot 220349) due to plastic thread contamination. The dry ingredient was distributed only in New York.

    Product
    5912MOD-CAU Pre-Blend, item #991819, is a dry blend. Ingredients consist of Tapioca Starch, Long Grain Rice Flour, Cheese Powder [Cheddar Cheese (Cultured Pasteurized Milk, Salt, Enzymes), Disodium Phosphate, Salt], Rice Starch, Sugar, Salt, Encapsulated Baking Soda (Sodium…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1100-2025·2025-02-19

    Medical laser device recalled for inadequate safety operating instructions

    Ithera Medical is recalling the MSOT Acuity Echo medical laser device worldwide due to inadequate instructions for safe operation. Previous user manuals contained an incorrect Nominal Ocular Hazard Distance value.

    Product
    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2025·2025-02-19

    Medication Cabinet Recall: BD Pyxis MedStation Auxiliary 4000 Drawer and Door Failures

    The BD Pyxis MedStation Auxiliary 4000 medication cabinet may experience drawer and door failures, potentially delaying medication access in healthcare facilities.

    Product
    BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0541-2025·2025-02-19

    Riverside Cookies & Creme Granola Bars Recalled for Potential Metal Contamination

    Riverside Natural Foods is recalling Cookies & Creme Granola Bars nationwide due to possible metal contamination. Consumers should not consume the affected products.

    Product
    1. Cookies & Creme Granola Bars 30.6oz (36 bars) 2. Cookies & Creme Granola Bars 5.1oz (6 bars) 3. Cookies & Creme Granola Bars 0.85 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2025·2025-02-19

    Cardinal Health Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 973,785 units were distributed to the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1139-2025·2025-02-19

    Stryker Precision Thin surgical blade attachments recalled for specification defect

    Stryker is recalling Precision Thin surgical blade attachments that may be out of specification and fail to fit securely into compatible handpieces. The defect affects 238 units distributed worldwide, with no reported injuries.

    Product
    stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0546-2025·2025-02-19

    Chocolate Drizzled Vanilla Granola Bars Recalled for Potential Metal Contamination

    Riverside Natural Foods is recalling Chocolate Drizzled Vanilla Granola Bars nationwide due to potential metal piece contamination. Affected products should not be consumed.

    Product
    1.Chocolate Drizzled Vanilla Granola Bars 25.5oz (30 bars) 2. Chocolate Drizzled Vanilla Granola Bars 4.2oz (5 bars) 3. Chocolate Drizzled Vanilla Granola Bars 0.85oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2025·2025-02-19

    Spore Test Monitoring System Printing Error May Cause Result Misdirection

    HF Acquisition Co LLC is recalling Bio52 and Bio12 HealthFirst Mail In Monitoring Systems (4,021 units) due to a printing error on return envelopes that may cause spore test results to be reported to incorrect customer accounts.

    Product
    Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1166-2025·2025-02-19

    Novation XLE hip implant components recalled for missing barrier layer

    Exactech is recalling Novation XLE hip implant components due to absence of an Ethylene Vinyl Alcohol (EVOH) barrier layer. Patients with affected implants should contact their healthcare provider.

    Product
    Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL…
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1130-2025·2025-02-19

    Cardinal Health Maxillofacial Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource maxillofacial surgical kits containing non-sterile strips and patties may have endotoxin contamination. 973,785 units distributed in the US, Canada, and Saudi Arabia are affected; users should stop using and contact the manufacturer.

    Product
    Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0536-2025·2025-02-19

    MadeGood Chocolate Chip Granola Bars Recalled for Possible Metal Contamination

    Riverside Natural Foods is recalling MadeGood Chocolate Chip Granola Bars nationwide due to possible metal contamination. No illnesses have been reported.

    Product
    1. MadeGood Chocolate Chip Granola Bars 34oz (40 bars) 2. MadeGood Chocolate Chip Granola Bars 53.55 oz (63 bars) 3. MadeGood Chocolate Chip Granola Bars 5.1oz (6 bars) 4. MadeGood Chocolate Chip Granola Bars 10.2oz (12 bars) 5. MadeGood Chocolate Chip Granola Bars 20.4oz (24…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0543-2025·2025-02-19

    Riverside Natural Foods Recalls Birthday Cake Granola Bars for Possible Metal Contamination

    Riverside Natural Foods is recalling Chocolate Drizzled Birthday Cake Granola Bars in multiple sizes nationwide because they may contain metal pieces. Consumers should discard the product or return it to the retailer.

    Product
    1. Chocolate Drizzled Birthday Cake Granola Bars 25.5oz (30 bars) 2. Chocolate Drizzled Birthday Cake Granola Bars 4.2oz (5 bars) 3. Chocolate Drizzled Birthday Cake Granola Bars 17oz (20 bars) 4. Chocolate Drizzled Birthday Cake Granola Bars 8.5oz (10 bars) 5. Chocolate…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1168-2025·2025-02-19

    MediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect

    Integra LifeSciences is recalling MediHoney Gel Wound & Burn Dressing Gel (Model 31815) due to potential induction seal defects in the tube packaging. Approximately 12,166 units were distributed worldwide, including throughout the United States and Malaysia.

    Product
    Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2025·2025-02-19

    Cardinal Health Presource Kits recalled for endotoxin contamination risk

    Cardinal Health is recalling Presource Kits containing surgical strips and patties due to potential endotoxin contamination. Approximately 973,785 units were distributed in the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0555-2025·2025-02-19

    Orange Jelly Sticks Recalled for Undeclared Food Additives

    The Candy Basket Inc recalls Orange Jelly Sticks MILK for undeclared Yellow #6 and Sodium Benzoate affecting 516 4-lb. boxes distributed in California, Oregon, and Washington.

    Product
    Orange Jelly Sticks MILK, item number CB741-M, is packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases from candy stores to consumers without any labeling. Label on bulk 4lbs. box…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1119-2025·2025-02-19

    Pyxis Medication and Anesthesia Dispensing Systems Recalled for Software Vulnerabilities

    CareFusion recalls Pyxis medication dispensing systems due to software issues that could delay access to medications, result in incorrect doses, or allow unauthorized access.

    Product
    (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
    Category
    Medical Device
    Distribution
    Distributed nationwide