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.

4276–4300 of 88106

  • HighFDA (Devices)·Z-1095-2026·2026-01-21

    Coagulation reagent recalled over potential for microbial contamination

    Instrumentation Laboratory is recalling 7,720 units of a coagulation reagent used for evaluating the intrinsic pathway and monitoring heparin therapy over potential microbial contamination.

    Product
    The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1044-2026·2026-01-21

    SMV DSX New Line systems recalled over a potential detector fall

    GE HealthCare is recalling 7 units of the SMV DSX New Line nuclear medicine system, because systems moved without adequate detector support may suffer a detector fall.

    Product
    SMV DSX New Line, System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1100-2026·2026-01-21

    Arterial blood sampling kits recalled over a crack on the syringe collar

    ICU Medical is recalling 64,290 Pulsator Arterial Blood Sampling Kits because syringes may have a crack on the collar, which may lead to blood leakage and repeated draws.

    Product
    Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0261-2026·2026-01-21

    Frozen raw shrimp recalled over elevated levels of chloramphenicol

    AZ Gems is recalling 1,099 cases of Member's Mark Jumbo Raw Shrimp over elevated levels of chloramphenicol.

    Product
    Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1052-2026·2026-01-21

    Holiday cookie tins recalled over undeclared almond, pecan and walnut

    One Roof LLC is recalling 197 Atwater's Holiday Cookie Tins over undeclared tree nut allergens: almonds, pecans and walnuts.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0269-2026·2026-01-21

    Excedrin recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Excedrin over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    EXCEDRIN 2'S DISP.- 30 CT
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0384-2026·2026-01-21

    Banana pudding ice cream recalled over undeclared soy lecithin

    House Of Flavors is recalling 2,388 units of 1972 Banana Pudding Ice Cream, 3 gallon, over undeclared soy lecithin.

    Product
    1972 Banana Pudding Ice Cream, 3 GAL, UPC 0 75196 00556 6
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-1018-2026·2026-01-21

    MRI systems recalled over ice that may block magnet venting

    Canon Medical Systems is recalling 22 Vantage Titan 3T MRI systems because ice in the magnet venting system could lead to a helium vessel rupture during a quench.

    Product
    VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1071-2026·2026-01-21

    MRI systems recalled over ice that may block the magnet venting system

    Canon Medical Systems is recalling 34 Vantage Galan 3T MRI systems because ice may form in the venting system, and a quench in that condition could rupture the helium vessel.

    Product
    Allura Xper FD20 Biplane; Model Number: 722013;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2026·2026-01-21

    Circulatory support blood pumps recalled over locking into the motor

    Thoratec is recalling 8,399 CentriMag blood pump products after reports that the pump may not fit or lock securely into the motor using the screw-in locking feature.

    Product
    CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1091-2026·2026-01-21

    Azurion systems recalled over six identified software issues

    Philips Medical Systems Nederland is recalling 10,466 Azurion systems on software versions R2.1.10 and R2.2.10 over six identified software issues including continuous restart.

    Product
    Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1086-2026·2026-01-21

    Laparoscopy kits recalled over suction irrigators that can leak during use

    Medline is recalling 41,432 laparoscopy convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.

    Product
    Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, REF CDS983679K; 5) LAP CHOLE CDS-LF, REF CDS983752M; 6) LAP CHOLE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1070-2026·2026-01-21

    Surgical procedure packs recalled over recalled B. Braun administration sets inside

    Medline is recalling 338 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    Allura Xper FD20; Model Number: 722012;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1087-2026·2026-01-21

    PALACOS MV bone cement recalled because ampoules may not break

    Heraeus Medical is recalling PALACOS MV pro 40 and PALACOS MV pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.

    Product
    Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1083-2026·2026-01-21

    Procedure kits recalled over suction irrigators that can leak during use

    Medline is recalling 4,536 procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.

    Product
    Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1054-2026·2026-01-21

    Facial procedure packs recalled over recalled B. Braun administration sets inside

    Medline is recalling 16 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1060-2026·2026-01-21

    Allura Xper FD10 systems recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 56 units of the Allura Xper FD10, model 722010, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1076-2026·2026-01-21

    Preoperative kits recalled over recalled B. Braun administration sets inside

    Medline is recalling 11173 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    Allura Xper FD20/10; Model Number: 722029;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0256-2026·2026-01-21

    Fluocinolone topical solution recalled after failing an impurity specification

    Sun Pharmaceutical Industries is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution 0.01% after an out of specification result for a known impurity.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1067-2026·2026-01-21

    Allura Xper FD20 Biplane systems recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 18 units of the Allura Xper FD20 Biplane, model 722008, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD20 Biplane; Model Number: 722008;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1068-2026·2026-01-21

    Allura Xper FD10, model 722026, recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 95 units of the Allura Xper FD10, model 722026, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD10; Model Number: 722010;
    Category
    Medical Device
    Distribution
    Distributed nationwide