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.

101–125 of 27263

  • HighFDA (Devices)·Z-2638-2026·2026-07-08

    Baxter Head Positioning Adapter May Loosen During Patient Positioning

    Baxter Healthcare is recalling an Adapter for Head Positioning (Model 1739994) used on operating tables because it may become loose and unintentionally move during patient positioning.

    Product
    Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2631-2026·2026-07-08

    CRE Pro Wireguided esophageal stent device recalled for packaging sterility

    Boston Scientific is recalling CRE Pro Wireguided 18-20mm 240cm esophageal stents due to potential sterile breach of product pouches. The breach could allow contamination of sterile devices.

    Product
    CRE Pro Wireguided 18-20mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2026·2026-07-08

    CRE Pro Wireguided medical device sterile packaging breach recall

    Boston Scientific Corporation is recalling the CRE Pro Wireguided 10-12mm 240cm device due to potential sterile breach of the pouches in which devices are packaged. The affected product has been distributed worldwide.

    Product
    CRE Pro Wireguided 10-12mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2026·2026-07-08

    IntelliCuff Portable Automatic Cuff Pressure Controller Recall

    Hamilton Medical AG is recalling the IntelliCuff portable automatic cuff pressure controller due to a reported "Cuff System Leakage" error that may cause the motor to pump continuously and fail to maintain user-set cuff pressure.

    Product
    IntelliCuff, Portable automatic cuff pressure controller REF: 951001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2608-2026·2026-07-08

    Medline Convenience Kits with Recalled Swan-Ganz Catheters

    Medline Industries is recalling convenience kits containing Swan-Ganz catheters due to defects in the proximal injectate lumen hub that may leak or break, risking infection, medication loss, and blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE DYNJ8407
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2606-2026·2026-07-08

    Medline Convenience Kits with Swan-Ganz Catheters Recalled

    Medline Industries is recalling convenience kits containing Swan-Ganz catheters due to leaks and breakage of the proximal injectate lumen hub, which may cause infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0655-2026·2026-07-08

    Prednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance

    Lupin Pharmaceuticals is recalling Prednisolone Acetate Ophthalmic Suspension, USP, 1% due to the presence of a foreign substance. Affected lot numbers were distributed nationwide.

    Product
    PREDNISOLONE ACETATE — PREDNISOLONE ACETATE (PREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1136-2026·2026-07-08

    Pepperoni Rolls Recalled for Undeclared Milk Allergen and Temperature Control Failure

    Fry Pie Factory LLC is recalling pepperoni rolls (5 oz, UPC 601959803041) distributed in Ohio and West Virginia due to undeclared milk allergen and failure to maintain required refrigeration during storage.

    Product
    Pepperoni Rolls, Net Wt. 5 oz (141g), individually packaged in a clear plastic bag, UPC 601959803041
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2670-2026·2026-07-08

    Radius VSM ECG Pre-connected Set Recalled for Incorrect Heart Rate Detection

    Masimo Corporation is recalling Radius VSM ECG pre-connected sets because the ECG electrode assembly may incorrectly detect extreme bradycardia or tachycardia and trigger false alarms on patients with normal heart rates, potentially distracting clinicians from true positive alarms and delaying treatment.

    Product
    Radius VSM ECG pre-connected Set, REF: 4842, 4695
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2609-2026·2026-07-08

    Medline Convenience Kits Containing Recalled Swan-Ganz Catheters

    Medline is recalling convenience kits containing Swan-Ganz catheters due to leaks and breakage of the proximal injectate lumen hub, which may cause infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2639-2026·2026-07-08

    Pilling Wecksorb Neurosponges Surgical Sponges Recalled for Endotoxin Contamination

    Teleflex LLC is recalling Pilling Wecksorb Neurosponges and Neurosponge Strips due to out-of-specification or potentially out-of-specification endotoxin levels. The cotton surgical sponges are used in brain and spine surgery.

    Product
    Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2643-2026·2026-07-08

    ARTIS icono floor Medical Imaging System Detector Movement Loss Recall

    Siemens Medical Solutions is recalling 30 units of the ARTIS icono floor (Model 11327700) due to potential loss of detector movement capability when adjusted to maximum or minimum height limits.

    Product
    ARTIS icono floor. Model Number: 11327700.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2613-2026·2026-07-08

    Medline Convenience Kits with Recalled Swan-Ganz Catheters

    Medline Convenience kits containing Swan-Ganz catheters recalled by Becton Dickinson are being recalled due to leaks and breakage of the proximal injectate lumen hub, which may result in infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465F DYNJ903465G HEART TRAY-VASCULAR DYNJ907857 DYNJ907857A DYNJ90
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2612-2026·2026-07-08

    Medline Convenience Kits with Recalled Swan-Ganz Catheters

    Medline Convenience kits containing recalled Swan-Ganz catheters may leak or break at the proximal injectate lumen hub, risking infection, medication loss, and blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·N/A·2026-07-08

    Beak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination

    Beak & Skiff Sanitizer Alcohol Antiseptic 80% is being recalled because FDA analysis found acetaldehyde above specification limits in the product. The recall affects bottles distributed in New York and through online sales.

    Product
    GLUCAGON — GLUCAGON (GLUCAGON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2642-2026·2026-07-08

    ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall

    Siemens Medical Solutions is recalling 119 units of the ARTIS icono ceiling (Model 11328100) due to potential loss of movement capability when the detector lift height is adjusted to its maximum or minimum limits.

    Product
    ARTIS icono ceiling. Model Number: 11328100.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1129-2026·2026-07-08

    MorningStar Farms Buffalo Chik'n Nuggets recalled for potential plastic contamination

    MorningStar Farms Buffalo Chik'n Nuggets (10.5 oz.) are being recalled due to potential contamination with plastic material. Affected products have Best If Used By dates of JUL 07 2027 and JUL 08 2027.

    Product
    MorningStar Farms Buffalo Chik'n Nuggets, 100% Plant Protein Vegan Nuggets, Net Wt. 10.5 oz. (298g), packaged in a resealable plastic bag with UPC 028989101105, packed 6 bags per case
    Category
    Food
    Distribution
    40 states
  • HighFDA (Devices)·Z-2637-2026·2026-07-08

    CRE Wireguided 18-20mm 240cm medical devices recalled for sterile breach

    Boston Scientific Corporation is recalling CRE Wireguided 18-20mm 240cm devices worldwide due to a potential sterile breach of the pouches in which the devices are packaged.

    Product
    CRE Wireguided 18-20mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2629-2026·2026-07-08

    Boston Scientific CRE Pro Wireguided 12-15mm Esophageal Stent Recall

    Boston Scientific is recalling CRE Pro Wireguided 12-15mm 240cm esophageal stents due to a potential sterile breach in the device packaging. Affected units were distributed worldwide.

    Product
    CRE Pro Wireguided 12-15mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2617-2026·2026-07-08

    DePuy Synthes ATTUNE Revision Hinge Knee Insert Components Recall

    DePuy Synthes is recalling ATTUNE Revision Hinge Knee Insert Components distributed to Minnesota, North Carolina, and Texas because external sterile packaging was found adhered to internal sterile packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410. 2. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 12mm B; Part Number: 151730412.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2614-2026·2026-07-08

    Mentor Texas LP Recalls Expired Luer Lok Syringes Due to Distribution Error

    Mentor Texas LP is recalling a single lot of expired 10cc Luer Lok syringes distributed to California, Florida, and Pennsylvania due to a distribution system control failure.

    Product
    SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2635-2026·2026-07-08

    CRE Wireguided Device Recall Due to Potential Sterile Packaging Breach

    Boston Scientific Corporation is recalling CRE Wireguided 12-15mm 240cm devices due to a potential sterile breach in the pouches containing the devices. The breach could compromise device sterility.

    Product
    CRE Wireguided 12-15mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2661-2026·2026-07-08

    Power-Trialysis Slim-Cath Dialysis Catheters Recalled by Bard Access Systems

    Bard Access Systems is recalling Power-Trialysis Slim-Cath short-term dialysis catheters due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects multiple product models distributed nationwide and internationally.

    Product
    5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0656-2026·2026-07-08

    Levothyroxine Sodium 300 mcg Tablets Recalled for Subpotency

    Accord Healthcare is recalling Levothyroxine Sodium Tablets 300 mcg (90-tablet bottles) nationwide due to subpotency. The affected lot is D2401522 with expiration date 06/2026.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2541-2026·2026-07-08

    Medline Convenience Kits Recalled Due to Lidocaine Quality Issues

    Medline Industries is recalling multiple convenience kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing site.

    Product
    Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B; 3) 20G x 6" ARTERIAL CATHETER KIT, Model Number: ART356; 4) MULTIMED 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC03; 5) A-LINE KIT, NO CATH, Mo
    Category
    Medical Device
    Distribution
    Distributed nationwide