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.

1851–1875 of 88106

  • SevereFDA (Devices)·Z-2364-2026·2026-06-24

    Arrow access trays and StimuCath kits contain recalled supplier drugs

    Arrow access trays and StimuCath safety kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 205,685 units affected.

    Product
    Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2360-2026·2026-06-24

    Automated Impella Controller software error affects left ventricular support devices

    Automated Impella Controllers are being recalled because of a potential software error when used with left ventricular Impella devices. 10,297 units are affected.

    Product
    Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2385-2026·2026-06-24

    Arrow access trays and PSI kits contain recalled supplier drugs

    Arrow access trays and PSI kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 426,041 units are affected.

    Product
    Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA; PSI KIT: 9 FR X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2363-2026·2026-06-24

    Arrow paracentesis kits contain drugs from a recalled supplier

    Arrow paracentesis kits, REF AK-00376 and ASK-00376-VCU, are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 50,724 units affected.

    Product
    PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2395-2026·2026-06-24

    Arrow PICC access trays contain drugs from a recalled supplier

    The Arrow PICC Access Tray, REF ASK-04001-CG1, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 360 units affected.

    Product
    Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2382-2026·2026-06-24

    Arrow drainage and thoracentesis kits contain recalled supplier drugs

    Arrow drainage and thoracentesis kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 444,943 units are affected.

    Product
    Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-01000-CHP, DRAINAGE KIT/ASK-01000-NW, THORACENTESIS KIT/ASK-01000-UPMS, PNEUMOTHORAX KIT/AK-01500…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2381-2026·2026-06-24

    Arrow 12 Fr hemodialysis kit contains drugs from a recalled supplier

    The Arrow two-lumen 12 Fr x 16 cm hemodialysis kit is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,945 units affected.

    Product
    Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2366-2026·2026-06-24

    Arrow pacing PSI kits contain drugs from a recalled supplier

    Arrow Pacing PSI kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 15,915 units are affected.

    Product
    Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2457-2026·2026-06-24

    Impella CP sets may lose mechanical circulatory support from low purge pressure

    Impella CP Sets with SmartAssist are being recalled because a low purge pressure occurrence may cause persistent alarms and, in some cases, interruption or loss of circulatory support.

    Product
    Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Food)·H-0953-2026·2026-06-24

    White cheddar popcorn seasoning made with Salmonella-recalled milk powder

    Fireworks Popcorn White Cheddar Seasoning is being recalled because it was made with recalled California Dairies milk powder due to Salmonella. 1,407 jars are affected.

    Product
    White Cheddar Seasoning packed in the following sizes and configurations: 1. Net Wt. 1.2 oz (34g) Distributed by: Fireworks Popcorn, Division of Jonco Industries, Milwaukee, WI 53218. Sold in a Fireworks Popcorn, Natural American Popcorn Popping & Toppings gift set.…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2374-2026·2026-06-24

    Arrow AHDC catheter kits contain drugs from a recalled supplier

    Arrow AHDC three-lumen catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 4,270 units affected.

    Product
    Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPN1A; AHDC AGB U-BEND KIT: 2-L 12 FR X 20…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2376-2026·2026-06-24

    Arrow central venous catheter kits contain drugs from a recalled supplier

    Arrow central venous catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 308,263 units affected.

    Product
    Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH; 3L PI CVC KIT: 7 FR X 16 CM/ASK-12703-PNM; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PUMH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2373-2026·2026-06-24

    Arrow hemodialysis catheter kits contain drugs from a recalled supplier

    Arrow two-lumen hemodialysis kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 15,425 units affected.

    Product
    Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYSIS KIT 2L: 14 FR X 20CM AGB/AK-25142-CDC; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UMD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1076-2026·2026-06-24

    Legacy Tex dressing stabilizer blend tested positive for Salmonella

    Legacy Tex Dressing Stabilizer Blend #7604-50 in 50 lb bags is being recalled because the product tested positive for Salmonella. 546 bags are affected.

    Product
    Legacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2465-2026·2026-06-24

    ConMed AirSeal 12mm access ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports and Obturators with Blunt Tip are being recalled because of the potential for overpressure alerts. 891 packs, or 5,346 units, are affected.

    Product
    ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2513-2026·2026-06-24

    iLet Bionic Pancreas pumps may become stuck on the lock screen

    The iLet Bionic Pancreas is being recalled because a screen unlock failure can leave the user stuck on the Lock Screen, unable to change the cartridge or announce a meal.

    Product
    iLet Bionic Pancreas, REF: BB1001
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2483-2026·2026-06-24

    Medline 14 Fr coude latex catheters fail performance specifications

    Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 14 Fr, are being recalled across all lots because samples did not meet performance specifications. 8,260 units affected.

    Product
    MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2514-2026·2026-06-24

    BD Connecta stopcock Port C may over thread rather than tightening

    BD Connecta BD Luer-Lok 360 stopcocks, REF 394910, are being recalled because the Port C connection may over thread or spin rather than tightening securely. 2,465,500 units affected.

    Product
    BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic…
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-2515-2026·2026-06-24

    Inspire respiratory sensing leads labeled with Use By dates beyond shelf life

    Inspire Respiratory Sensing Leads, model 4340, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 50 units affected.

    Product
    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2026·2026-06-24

    TRIGEN proximal humeral nails are missing their distal holes

    TRIGEN Proximal Straight Humeral Nails 8/7 x 16 are being recalled because a manufacturing error left them missing distal holes. Five units are affected.

    Product
    TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2509-2026·2026-06-24

    STAAR ICL calculation software miscalculates toric lens orientation diagram printout

    STAAR ICL Calculation Software version 8.00 is being recalled because of a coding issue in calculating the implantation orientation diagram printout for toric implantable collamer lenses.

    Product
    Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2482-2026·2026-06-24

    Medline red rubber urethral catheterization trays fail performance specifications

    Medline Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled across all lots because samples did not meet performance specifications. 235,658 units affected.

    Product
    MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2518-2026·2026-06-24

    HeartMate 3 assist system kits recalled over backup battery failures

    HeartMate 3 Left Ventricular Assist System kits, model 106524US, are being recalled due to 11 volt backup battery failures. Four units are affected.

    Product
    Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2484-2026·2026-06-24

    Medline coude latex catheters fail applicable performance specifications

    Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 16 Fr, are being recalled across all lots because samples did not meet performance specifications. 10,980 units affected.

    Product
    MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C
    Category
    Medical Device
    Distribution
    Distributed nationwide