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.

5751–5775 of 88106

  • HighFDA (Devices)·Z-0148-2026·2025-10-22

    Metal and ceramic femoral heads recalled over sterile barrier packaging defect

    BioPro is recalling 147 cobalt chromium and ceramic femoral heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.

    Product
    BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0168-2026·2025-10-22

    Twelve foot display cables recalled over inadequate shielding and interference

    Spacelabs Healthcare is recalling 820 twelve-foot 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: 012-0895-12 Software Version: N/A Product Description: 12 foot 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 (Devices)·Z-0140-2026·2025-10-22

    CX preconnect pumps without InhibiZone recalled over inflation deflation issues

    Boston Scientific is recalling CX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2026·2025-10-22

    Cyclodialysis surgical instruments recalled over compromised sterile packaging integrity

    Iantrek is recalling 1,262 CycloPen Microinterventional Cyclodialysis Systems over the potential for compromised integrity of the sterile packaging.

    Product
    Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0057-2026·2025-10-22

    Frozen bean and rice burritos recalled over potential foreign object contamination

    Amy's Kitchen is recalling 3,238 cases of Gluten Free Bean & Rice Burrito, totaling 38,856 retail units, for potential contamination with foreign objects.

    Product
    Gluten Free Bean & Rice Burrito. 12 retail units per case. 5.5oz/retail unit. UPC code 042272003525. Frozen.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0197-2026·2025-10-22

    Forty four inch extension sets recalled because the IV sets may leak

    Baxter is recalling 15,552 CLEARLINK System 44-inch 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, 44-inch (111 centimeters), Product code 2C8610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0045-2026·2025-10-22

    Strawberry lemonade pints recalled over potential foreign object contamination

    Wawa Beverage Company is recalling 2,750 units of Wawa Strawberry Lemonade in 16 oz bottles for potential foreign object contamination.

    Product
    Wawa Strawberry Lemonade, 16 oz (Pint), Plastic bottle, Stored refrigerated, UPC: 007626191018982
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·H-0058-2026·2025-10-22

    Aluminium cookware sets recalled for containing elevated levels of lead

    Goyal Group is recalling 293 sets of Silver Horse aluminium milk pans and mathar kadai cookware because they contain elevated levels of lead.

    Product
    1. SILVER HORSE - PURE ALUMINIUM MADE IN INDIA - ALUMINIUM MILK PAN 4 inches 2. SILVER HORSE - ALUMINIUM MATHAR KADAI - 26 inches
    Category
    Consumer Product
    Distribution
    13 states
  • HighFDA (Food)·H-0134-2026·2025-10-22

    Baby food pouches recalled over potential lead contamination in four lots

    Sprout Organics is recalling 9,873 cases of its Sweet Potato, Apple & Spinach baby food for potential contamination with lead.

    Product
    6+ Months SPROUT ORGANICS Made With Organic Sweet Potato, Apple & Spinach NET WT. 3.5 OZ (99g) INGREDIENTS: ORGANIC SWEET POTATOES, ORGANIC APPLES, ORGANIC SPINACH, WATER, ORGANIC LEMON JUICE. Dist. by Sprout Foods, Inc. Montvale, NJ 07645 UPC: 818512011762
    Category
    Food
    Distribution
    34 states
  • HighFDA (Devices)·Z-0181-2026·2025-10-22

    Caesarean section packs recalled after being sterilized more than once

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

    Product
    Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2026·2025-10-22

    Retractable collar solution sets recalled across many lots because sets may leak

    Baxter is recalling 958,351 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2026·2025-10-22

    Six foot display cables recalled over inadequate shielding and interference

    Spacelabs Healthcare is recalling 8,179 six-foot 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: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0141-2026·2025-10-22

    LGX preconnect pumps without InhibiZone recalled over inflation deflation issues

    Boston Scientific is recalling LGX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2026·2025-10-22

    Head and neck procedure packs recalled after being sterilized more than once

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

    Product
    Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2026·2025-10-22

    Radiology procedure packs recalled after being sterilized more than once

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

    Product
    Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2026·2025-10-22

    Three valve retractable collar sets recalled across many lots for leak potential

    Baxter is recalling 1,167,120 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0173-2026·2025-10-22

    Labor and delivery packs recalled after being sterilized more than once

    American Contract Systems is recalling labor, delivery and birthing room convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY EVBH28D BIRTHING ROOM PACK UPVD01K VAGINAL DELIVERY PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0029-2026·2025-10-22

    Parkinson's tablets recalled after bottles contained a higher strength tablet

    Rising Pharma is recalling 2,064 bottles of Carbidopa, Levodopa and Entacapone Tablets 25/100/200 mg after a sealed bottle was found to contain the 37.5/150/200 mg strength instead.

    Product
    CARBIDOPA, LEVODOPA AND ENTACAPONE — CARBIDOPA, LEVODOPA AND ENTACAPONE (CARBIDOPA, LEVODOPA AND ENTACAPONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2026·2025-10-22

    Humidifier devices recalled because power loss alert sounds under two minutes

    Fisher & Paykel is recalling 51,144 Airvo 2 and myAirvo 2 humidifiers because an unintentional power disconnection may sound an audible alert for less than 120 seconds.

    Product
    Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2026·2025-10-22

    Cardiac catheterization packs recalled after being sterilized more than once

    American Contract Systems is recalling cardiac catheterization and cath lab convenience packs that were re-gassed after a sterilization nonconformance.

    Product
    Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)
    Category
    Medical Device
    Distribution
    Distributed nationwide