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.

8276–8300 of 88183

  • SevereFDA (Devices)·Z-1521-2025·2025-04-23

    Ballard Closed Suction Catheters recalled for lack of sterility assurance

    Avanos Medical is recalling Ballard Closed Suction Catheters (Model 198, 8 F, Y-Adapter) for neonates and pediatrics due to lack of sterility assurance. The recall affects 1,980 units distributed nationwide and internationally.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1559-2025·2025-04-23

    Welch Allyn CONNEX Power Management Stand Battery Fire Risk

    Baxter Healthcare is recalling the Welch Allyn CONNEX Accessory Power Management Stand due to reports of battery-related fires caused by unapproved third-party batteries.

    Product
    Welch Allyn CONNEX Accessory Power Management Stand:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1526-2025·2025-04-23

    Ballard Closed Suction Catheters recalled due to sterility assurance failure

    Avanos Medical is recalling 1,420 units of Ballard Closed Suction Catheters (Model 2271418-5) due to lack of sterility assurance. The affected product was distributed worldwide, including across the US and internationally.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1527-2025·2025-04-23

    Ballard Closed Suction Catheters lack sterility assurance

    Avanos Medical is recalling Ballard Closed Suction Catheters (Model 227-5) due to lack of sterility assurance. The recall affects 1,040 units distributed nationwide and internationally.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1570-2025·2025-04-23

    HeartMate Mobile Power Unit electrical malfunction may cause loss of power

    Thoratec LLC is recalling HeartMate Mobile Power Units due to an electrical component defect that may prevent the unit from turning on, cause unprompted shut down, or trigger false alarms. If power is lost and not switched to rechargeable batteries within 15 minutes, the connected pump may lose power.

    Product
    HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1523-2025·2025-04-23

    Ballard Closed Suction Catheters Recalled for Lack of Sterility Assurance

    Avanos Medical is recalling Ballard Closed Suction Catheters (Model 20083) due to lack of sterility assurance. The company has distributed approximately 9,960 units worldwide.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1525-2025·2025-04-23

    Ballard Closed Suction Catheters recalled for lack of sterility assurance

    Avanos Medical is recalling Ballard Closed Suction Catheters (Model 2210-5) because they lack adequate sterility assurance. The recall affects approximately 2,080 units distributed worldwide, including across most US states and several countries.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1564-2025·2025-04-23

    Welch Allyn Connex Vital Signs Monitor Recall: Undeclared Natural Rubber

    Baxter Healthcare Corporation is recalling certain Welch Allyn Connex Vital Signs Monitors due to an undeclared natural rubber band in the packaging of reusable blood pressure cuffs. The undeclared rubber may pose an allergen risk to individuals with natural rubber latex sensitivity.

    Product
    Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B; 4) ) Product Code/Part # 67MXXX-B; 5) ) Product Code/Part # 67NCTP-B; 6) ) Product…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1610-2025·2025-04-23

    Medline Sterile Convenience Kits Recalled for Breather Pouch Sealing Defect

    Medline Industries has recalled five sterile convenience kits for various neurosurgical and implant procedures due to potential open or weak seals on breather pouches used in packaging. The defect could compromise sterility of the devices.

    Product
    Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50629M; 4) SHUNT PACK, Model Number: DYNJ40040C; 5) STIM IMPLANT PACK, Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1604-2025·2025-04-23

    Medline Convenience Kits Recalled for Potential Breather Pouch Seal Defects

    Medline is recalling select IV convenience kits due to potential open or weak seals on breather pouches used for packaging. The defective seals may compromise sterility of the medical devices.

    Product
    Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1600-2025·2025-04-23

    Medline sterile surgical convenience kits with potentially weak seals

    Medline Industries is recalling 33 models of sterile surgical convenience kits due to potential open or weak seals on breather pouches used for packaging. The defect may compromise sterility of the kits.

    Product
    Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Number: DYNJ65109; 3) PLASTIC PROCEDURE PACK, Model Number: DYNJ34160D; 4) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 5) PLASTIC PACK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0708-2025·2025-04-23

    Arepas de Chocolo recalled for undeclared soy allergen

    Delicias de la Abuela Inc. is recalling Arepas de Chocolo due to the presence of undeclared soy lecithin. Consumers with soy allergies should not consume this product.

    Product
    Arepas de Chocolo, Abuelas Food Company, Delicias de la Abuela's, Net Weight: 22.5oz. (638g), 5 units per package, Vacuum seal packages and twist tie bags, KEEP REFRIGERATED. UPC 850283002037
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1612-2025·2025-04-23

    Medline Convenience Kits Recalled for Potential Open Breather Pouch Seals

    Medline Industries is recalling select sterile convenience kits (Model DYNJ80807B, Lot 24IBH993) due to potential open or weak seals on breather pouches used for packaging. Compromised seals may affect product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1554-2025·2025-04-23

    Philips DXR System DuraDiagnost Rel. 4 X-Ray System Collimator Fall Risk

    Philips is recalling 83 units of the DXR System, DuraDiagnost Rel. 4 stationary X-ray system due to potential for the collimator to fall if incorrectly installed. The defect could pose injury risk to patients or staff.

    Product
    Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2025·2025-04-23

    Medline sterile convenience kits recalled for potential weak breather pouch seals

    Medline Industries is recalling ten models of sterile convenience kits used for various medical procedures due to potential open or weak seals on breather pouches. The seal failure could compromise sterility of the kits.

    Product
    Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B; 3) BILAT TESTICULAR SPERM EXTRACT, Model Number: DYNJ68303; 4) PROCEDURE MINEURE BJC-LF, Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2025·2025-04-23

    BD Pyxis MedBank Receiving Cabinet Software Medication Dispensing Safety Issue

    CareFusion 303 is recalling certain BD Pyxis MedBank Receiving Cabinet Software versions because a "Clear All" function may bypass pharmacist validation, potentially allowing incorrect medication dispensing without authorization.

    Product
    MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0713-2025·2025-04-23

    Tony's Chocolonely Everything Bar recalled for foreign objects

    Tony's Chocolonely Inc is recalling Tony's Chocolonely Everything Bar products nationwide due to the presence of stones in the chocolate bars.

    Product
    Tony's Chocolonely Everything Bar
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1596-2025·2025-04-23

    Medline Rhinoplasty Pack kits recalled for potential breather pouch seal failures

    Medline is recalling Rhinoplasty Pack convenience kits (Model DYNJ27333F) due to potential open or weak seals on breather pouches used to package the sterile kits.

    Product
    Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2025·2025-04-23

    Guide Wire with Ruler Tube 3x800 mm Metal Ring Detachment Recall

    Stryker GmbH is recalling the Guide Wire with Ruler Tube 3x800 mm DIA because the metal ring at the end may detach during surgery. The defect could interfere with the surgical procedure.

    Product
    Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2025·2025-04-23

    Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals

    Medline Industries is recalling sterile convenience kits for various medical procedures due to potential open or weak seals on breather pouches used in product packaging.

    Product
    Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B; 5) CATH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0710-2025·2025-04-23

    Salvadorena Quesadilla de Queso Recalled for Undeclared Milk

    Panaderia Salvadorena Ii is recalling Quesadilla de Queso products that contain undeclared milk, a common allergen that poses a risk to consumers with milk allergies.

    Product
    PANADERIA/BAKERY Salvadorena; Quesadilla de Queso; Ingredients: Rice, Wheat Flour, soy, eggs, sugar, butter, baking powder, salt, water, sour cream, sesame seeds; UPC 0 21651 16499 6; NET WEIGHT APPROX 14 OZ
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1588-2025·2025-04-23

    Medline sterile convenience kits recalled for weak breather pouch seals

    Medline is recalling two models of sterile convenience kits (PAIN PACK and PAIN TRIAL PACK) due to potential open or weak seals on breather pouches used in the packaging.

    Product
    Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Model Number: DYNJ67576A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2025·2025-04-23

    Medline Sterile Ophthalmic Convenience Kits Recalled for Weak Breather Pouches

    Medline Industries is recalling select sterile ophthalmic convenience kits due to potential open or weak seals on breather pouches used for packaging. The kits are used for various eye procedures.

    Product
    Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK, Model Number: DYNJ63707C; 5) EYE PACK WITH ACCESSORY PACK, Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1557-2025·2025-04-23

    Abbott Aveir DR Leadless Pacemaker Recalled for Battery Failure Risk

    Abbott Medical is recalling specific Aveir DR Leadless Pacemaker devices due to manufacturing exposure to higher-than-normal temperatures that may cause premature battery failure.

    Product
    Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1599-2025·2025-04-23

    Medline Convenience Kits Recalled for Potential Weak Seals

    Medline Industries is recalling select sterile convenience kits due to a potential for open or weak seals on the breather pouches used for packaging. The affected kits are distributed nationwide and in Canada, Mexico, Panama, and the Virgin Islands.

    Product
    Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S
    Category
    Medical Device
    Distribution
    Distributed nationwide