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.

5676–5700 of 88106

  • CriticalFDA (Food)·H-0062-2026·2025-10-22

    Cut fresh fruit salad recalled over potential Listeria monocytogenes contamination

    Wholesale Produce Supply is recalling Harvest Cuts Cut Fresh Fruit Salad for potential Listeria monocytogenes contamination.

    Product
    Cut Fresh Fruit Salad. 6/6 oz. Harvest Cuts. Contains: Cantaloupe, Honeydew, Red Grape, Strawberry. Keep Refrigerated. Packed in the following container sizes: 1. 6/6 oz. UPC 7 90629-11822 3. 2. 4/16 oz. UPC 7 90629-08009 4. Packed by WPS, Minneapolois, MN
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Devices)·Z-0100-2026·2025-10-22

    ALTRUA 2 dual chamber extended life pacemakers recalled for software update

    Boston Scientific is recalling 3,376 ALTRUA 2 DR EL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number S722, ALTRUA 2 DR EL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0105-2026·2025-10-22

    VISIONIST MRI resynchronization pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 41,191 VISIONIST CRT-P EL MRI devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number U228, VISIONIST CRT-P EL MRI
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0102-2026·2025-10-22

    VALITUDE MRI resynchronization pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 28,911 VALITUDE CRT-P EL MRI devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number U128, VALITUDE CRT-P EL MRI
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0091-2026·2025-10-22

    PROPONENT dual chamber extended life MRI pacemakers recalled for software update

    Boston Scientific is recalling 63,851 PROPONENT DR EL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L231, PROPONENT DR EL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0111-2026·2025-10-22

    Curve D-F ablation catheters recalled after tip detachment from packaging

    Abbott is recalling 85,803 TactiFlex Sensor Enabled Ablation Catheters in the D-F curve after becoming aware of tip detachment events during removal from the packaging.

    Product
    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0046-2026·2025-10-22

    BF-1T180 bronchovideoscopes recalled for clarified instructions on therapy equipment

    Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type 1T180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0063-2026·2025-10-22

    Cut fruit mix recalled over potential Listeria monocytogenes contamination

    Wholesale Produce Supply is recalling 307 cases and pails of Fresh & Finest Cut Fresh Luau Blend Fruit Mix for potential Listeria monocytogenes contamination.

    Product
    Cut Fresh Luau Blend Fruit Mix "F&F". 4/10 oz. Fresh & Finest. Contains: Cantaloupe, Honeydew, Pineapple, Red Grapes, Strawberry, Blueberry. Keep Refrigerated. UPC 0 70253-00572 5. Packed by WPS, Minneapolois, MN
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Devices)·Z-0095-2026·2025-10-22

    Pacemakers recalled for software update preventing Safety Mode from battery impedance

    Boston Scientific is recalling 223,163 ESSENTIO DR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L111, ESSENTIO DR SL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0083-2026·2025-10-22

    ACCOLADE dual chamber extended life pacemakers recalled for software update

    Boston Scientific is recalling 7,488 ACCOLADE DR EL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    ACCOLADE DR EL (Model L321)
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·H-0055-2026·2025-10-22

    Large white eggs in cartons recalled over potential Salmonella contamination

    Black Sheep Egg Company is recalling 23,400 dozen Free Range Grade AA Large White Eggs in 12-count cartons for potential Salmonella contamination.

    Product
    Free Range Grade AA Large White Eggs, 12ct Cartons, 15dz per box, Black Sheep Egg Company 400 S Memorial Drive Walnut Ridge AR 72476
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Devices)·Z-0051-2026·2025-10-22

    BF-1TQ180 bronchovideoscopes recalled for updated therapy equipment use instructions

    Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type 1TQ180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0112-2026·2025-10-22

    Curve F-J ablation catheters recalled after tip detachment during unpacking

    Abbott is recalling 11,810 TactiFlex Sensor Enabled Ablation Catheters in the F-J curve after becoming aware of tip detachment events during removal from the packaging.

    Product
    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0177-2026·2025-10-22

    Central line insertion kits recalled after being sterilized more than once

    American Contract Systems is recalling 32,433 adult central line insertion supply kits that were re-gassed after a nonconformance, without validation for multiple sterilization cycles.

    Product
    Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0145-2026·2025-10-22

    Shoulder surgical planning software recalled over possible implant malalignment risk

    Kico Knee Innovation Company is recalling 21 ARVIS Shoulder systems after a complaint identified an issue with the AI surgical planning software that may cause implant malalignment.

    Product
    Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2026·2025-10-22

    Extension IV sets recalled from one lot because the sets may leak

    Baxter is recalling 16,416 CLEARLINK System straight-type extension sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0191-2026·2025-10-22

    Non-vented IV solution sets recalled from one lot because sets may leak

    Baxter is recalling 1,440 CLEARLINK System non-vented solution sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2026·2025-10-22

    Three valve filtered solution sets recalled because IV sets may leak

    Baxter is recalling 8,368 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a 0.2 micron filter from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2026·2025-10-22

    Cystoscopy procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling cysto convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2026·2025-10-22

    Monitor display cables recalled over inadequate shielding and electromagnetic interference

    Spacelabs Healthcare is recalling 16,898 DVI display cables because inadequate shielding may allow electromagnetic interference with other electronically sensitive medical devices in use.

    Product
    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0038-2026·2025-10-22

    Canned fruit cocktail recalled over potential lead contamination in one lot

    Pacific Coast Producers is recalling 609 cases of canned fruit cocktail in 100% juice for potential contamination with lead.

    Product
    Fruit Cocktail IN 100% JUICE WITH ADDED INGREDIENTS; NET WT 15 OZ (425 g); Ingredients: Diced Peaches, Diced Pears, Water, Grapes, Peach Pulp and Juice, Pineapple Sectors, Pear Juice Concentrate, Halved Cherries (colored red with Carmine), Ascorbic Acid (to protect color).…
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0153-2026·2025-10-22

    Femoral head implants recalled over packaging that may compromise sterile barrier

    BioPro is recalling 147 femoral head implants over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.

    Product
    BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·H-0034-2026·2025-10-22

    Raw cashew pouches recalled because the product contains undeclared pine nut

    Now Foods is recalling 1,689 pouches of NOW Real Food Organic Unsalted Whole Raw Cashews because the product contains undeclared pine nut.

    Product
    NOW Real Food Organic Unsalted Whole Raw Cashews, 10 oz. pouch, UPC 7 33739 07066 1 Product Code 7066
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2026·2025-10-22

    Spine and laminectomy packs recalled after being sterilized more than once

    American Contract Systems is recalling spine, laminectomy and neuro angio convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL…
    Category
    Medical Device
    Distribution
    Distributed nationwide