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.

9451–9475 of 27089

  • HighFDA (Devices)·Z-3049-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. The kits, distributed worldwide, may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049AF; 4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ; 5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS76008
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3029-2024·2024-09-18

    Medical Convenience Kits with Defective Plastic Syringes Recalled Worldwide

    Medline medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues that may harm patients. The kits were distributed worldwide and are used for invasive procedures like biopsies and lumbar punctures.

    Product
    Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 4) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324A; 5) BONE MARROW BIOPS
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3098-2024·2024-09-18

    Vital Signs Monitor Recalled Due to Inadequate Battery Warning Labels

    Zoe Medical is recalling 6,429 Spacelabs Ultraview DM3 Vital Signs Monitors because labeling does not adequately warn users about risks from damaged or expired batteries.

    Product
    Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0658-2024·2024-09-18

    Fluoride Dental Product Recalled Due to Label Mix-Up

    Just Right 5000 fluoride dental product is being recalled due to a label mix-up affecting 120 direct customers nationwide.

    Product
    Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3120-2024·2024-09-18

    Medline recalls surgical convenience kits in Class II recall

    Medline Industries is voluntarily recalling 720 units of convenience kits containing semi-rigid suction liners used in eye surgery and related procedures. The specific reason for the recall has not been disclosed.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, Pack Number DYNJ59921BH; c) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923B; d) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923BH;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3094-2024·2024-09-18

    Reprocessed Surgical Sealer/Divider Recalled for Potential Packaging Seal Defect

    Medline Industries is recalling the ReNewal Reprocessed Covidien LigaSure Impact Sealer/Divider due to a potential incomplete seal on the packaging tray. The recall affects 230 units nationwide.

    Product
    Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1806-2024·2024-09-18

    Walmart Macaroni Salad Recalled Due to Foreign Material

    Reser's Fine Foods is recalling Walmart Original Freshness Guaranteed Macaroni Salad due to foreign material contamination. Affected product has UPC 78742 02670 with a Use By date of Sep 18, 2024.

    Product
    UPC 78742 02670, Walmart Original Freshness Guaranteed Macaroni Salad 3lb. (48oz), refrigerated, packaged in an opaque printed plastic tub with a plastic white printed lid. There are 6 tubs per case.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-3073-2024·2024-09-18

    Medtronic InterStim Handset May Fail to Pair with Communicator

    Medtronic is recalling 211 InterStim Smart Programmer handsets that may not complete the pairing process with the communicator during initial setup.

    Product
    Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3103-2024·2024-09-18

    Diagnostic test shows measurement bias at critical threshold

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 19-9 test kits due to positive bias in measurements around the critical threshold of 35 U/mL, affecting diagnostic accuracy.

    Product
    ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3112-2024·2024-09-18

    Medline Suction Liners Recalled Due to Potential Loss of Suction

    Medline is recalling 1,616 units of semi-rigid suction liners (ENDO KIT, pack numbers DYKE1350D and DYKE1514B) manufactured September to November 2023 that may lose or provide reduced suction during use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3079-2024·2024-09-18

    FDA Recalls Syringe Tip Caps Due to Unapproved Device Modifications

    Sol-Millennium Medical Inc. is recalling certain Syringe Tip Cap models because they were modified without proper FDA clearance. The modified devices differ from their approved specifications.

    Product
    Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1802-2024·2024-09-18

    Reser's Spicy Pickle Potato Salad Recalled for Foreign Material

    Reser's American Classics Spicy Pickle Potato Salad (16 oz, UPC 71117 19084) is being recalled due to possible foreign material contamination. The voluntary recall affects products distributed across nine states.

    Product
    UPC 71117 19084, Reser's American Classics Spicy Pickle Potato Salad 16oz, refrigerated, packaged in an opaque printed plastic tub with a plastic red printed lid. There are 6 tubs per case.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1804-2024·2024-09-18

    Amazon Fresh Macaroni Salad recalled for foreign material contamination

    Reser's Fine Foods is recalling Amazon Fresh Fresh Classic Macaroni Salad due to foreign material contamination. The product was distributed in nine states with a use-by date of September 13, 2024.

    Product
    UPC 95515 04502, Amazon Fresh Fresh Classic Macaroni Salad 16oz, refrigerated, packaged in a clear plastic tub with printed labels on top, bottom and side. There are 12 tubs per case.
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1762-2024·2024-09-11

    JFE Pico de Gallo Classic Products Recalled for Listeria Contamination

    JFE FRANCHISING INC is recalling Pico de Gallo Classic products in Kentucky, Michigan, Ohio, and West Virginia due to potential Listeria monocytogenes contamination. Consumers should not consume affected products and should return them to the place of purchase or discard them.

    Product
    Pico de Gallo Classic Hot - 14 oz 639123880116 Pico de Gallo Classic Medium - 14 oz 639123880093 Pico de Gallo Classic Mild - 14 oz 639123880109 Plastic Clam-Shell Container
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-2943-2024·2024-09-11

    Trilogy Evo Ventilator Software Update for Identified Safety Issues

    Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for the Trilogy Evo Universal Ventilator to address safety issues identified in earlier recalls. Affected units should implement the update.

    Product
    Trilogy Evo Universal Ventilator, Model No. DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1781-2024·2024-09-11

    Popsicle Jolly Rancher Frozen Pops Recalled for Undeclared Milk Allergen

    Unilever North America is recalling Popsicle Jolly Rancher Frozen Confection Pops nationwide due to undeclared milk, which poses a risk to consumers with milk allergies.

    Product
    Popsicle Jolly Rancher Frozen Confection Pop Net Wt 2.71 FL OZ (80 ML). Green Apple Blue Raspberry and Grape flavored. GTIN/UPC 10077567003727 Case UPC 77567003720
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1794-2024·2024-09-11

    Terrafina Golden Raisins Recalled Due to Undeclared Sulfites

    Terrafina Golden Raisins (10oz) are being recalled due to undeclared sulfites. This FDA Class I recall affects products distributed to retailers in New York.

    Product
    Terrafina Golden Raisins Net Wt. 10oz (283g) UPC:847938001385. Packaged in a plastic container, 8 containers per case.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2721-2024·2024-09-11

    Fresenius Kabi IV Administration Sets Recalled for Uncontrolled Medication Flow Risk

    Fresenius Kabi is recalling LVP Primary Administration Sets due to a defect that may cause uncontrolled medication flow and potential overdose. The recall affects 4,500 pieces distributed in Colorado, Idaho, New Jersey, and Utah.

    Product
    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Food)·F-1760-2024·2024-09-11

    Chopped Cilantro with White Onion Recalled for Listeria

    JFE Franchising Inc recalls 5oz packages of chopped cilantro with white onion due to potential Listeria monocytogenes contamination. Affected products were distributed in Kentucky, Michigan, Ohio, and West Virginia.

    Product
    Chopped Cilantro with White Onion - 5oz Plastic Clam-Shell Container
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1763-2024·2024-09-11

    Diced Pepper and Fajita Mix Products Recalled for Listeria Contamination

    JFE FRANCHISING INC is recalling diced pepper and fajita mix products sold in Kentucky, Michigan, Ohio, and West Virginia due to potential Listeria monocytogenes contamination. Consumers should discard the products or return them to the store.

    Product
    Diced Pepper Tri-Blend - 8 oz 639123880024 Diced Pepper w/ White Onion - 7 oz 639123880048 Fajita Mix, Hot $5.00 - 11 oz 639123880406 Fajita Mix, Mild $5.00 - 11 oz 639123880390 Diced Jalapeno - 7oz 639123880031 Plastic Clam-Shell Container
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1764-2024·2024-09-11

    Guacamole products recalled due to Listeria monocytogenes contamination

    JFE Franchising is recalling guacamole products due to Listeria monocytogenes contamination. Affected items were distributed in Kentucky, Michigan, Ohio, and West Virginia with sell-by dates from July 9 to July 26, 2024.

    Product
    Guacamole & Pico de Gallo Combo $7.99 - 16 oz 639123880574 Guacamole Chunky Medium - 14 oz 639123880161 Guacamole Chunky Mild - 14 oz 639123880154 Guacamole Blender Mild $5.99 - 12 oz 639123880789 Plastic Clam-Shell Container
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1759-2024·2024-09-11

    Butternut Squash Cubes Recalled Due to Listeria Contamination Risk

    Butternut squash cubes sold in Kentucky, Michigan, Ohio, and West Virginia are recalled due to potential Listeria monocytogenes contamination. Affected products have sell-by dates between July 9 and July 26, 2024.

    Product
    Butternut Squash Cubes - 12oz Plastic Clam-Shell Container
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0649-2024·2024-09-11

    FDA Recalls Heparin Sodium Injection for Endotoxin Contamination

    Baxter Healthcare Corporation is recalling 44,208 containers of Heparin Sodium in Sodium Chloride Injection nationwide after endotoxin testing revealed out-of-limit results. The contamination poses a risk of serious adverse reactions in patients receiving the intravenous medication.

    Product
    HEPARIN SODIUM IN SODIUM CHLORIDE — HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2942-2024·2024-09-11

    Trilogy Evo EV300 Ventilator Mandatory Software Update for Safety Issues

    Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo EV300 ventilators to resolve previously identified safety issues. Approximately 90,910 US units and 56,273 international units are affected.

    Product
    Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2690-2024·2024-09-11

    Vivo 45 LS Ventilator Recall: Potential Formaldehyde Emission Risk

    Breas Medical is recalling the Vivo 45 LS ventilator due to potential elevated formaldehyde emissions into the patient breathing airpath under specific conditions.

    Product
    Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
    Category
    Medical Device
    Distribution
    Distributed nationwide