The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

8176–8200 of 52968

  • HighFDA (Devices)·Z-2232-2024·2024-07-10

    Medline Surgical Convenience Kits Recalled for Weak Seal Compromise

    Medline recalled 7,673 surgical convenience kits nationwide due to weak seals in the Pure Pouch component that may compromise sterility of surgical instruments. No injuries have been reported.

    Product
    Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2 Adult Kit, Pack ACC010365A, containing a Pure Pouch component DYNJ04048, Kelly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2024·2024-07-10

    Siemens ARTIS Angiography Systems May Deliver Unintended Radiation Doses

    Siemens ARTIS icono angiography systems with certain detectors may deliver higher-than-intended radiation doses in rare cases. The issue occurs when incorrect copper prefiltration is applied during initial x-ray exposure after patient registration.

    Product
    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2024·2024-07-10

    Medline surgical convenience kits recalled for weak seal integrity

    Medline surgical convenience kits containing Pure Pouch components with weak seals may fail to maintain sterility, potentially compromising the safety of contained medical instruments. Affected kits were distributed nationwide across 23 states.

    Product
    Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #DYNJ040408, Kelly Forceps/STD STR Sterile. b. Medline Adult/Child Intubation Kit, Pack #ACC010616 and Pack #ACC010616H, containing a P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2246-2024·2024-07-10

    Portable X-Ray Cart Positioning Arm Bolt May Come Loose and Fall

    First Source Inc is recalling the First Source Vision M portable X-ray cart because the bolt securing the positioning arm to the gas spring may come loose and fall onto a patient.

    Product
    First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2024·2024-07-10

    Zyno Medical Z800 Series Infusion Pumps: Faulty Power Supply May Prevent Battery Charging

    Certain Zyno Medical Z800 series infusion pumps contain faulty power supply modules that cannot charge the rechargeable battery. When unplugged from AC power, affected pumps may lack sufficient charge to operate.

    Product
    Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0579-2024·2024-07-10

    Methylphenidate Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution

    Trigen Laboratories recalls Methylphenidate Hydrochloride Extended-Release Tablets (36mg) because a batch failed dissolution specifications. Approximately 10,448 bottles were distributed nationwide.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1471-2024·2024-07-10

    Ice Cream Recall: Foreign Rubber Found in Cookie Dough Product

    Casper's Ice Cream recalls Red Button Vintage Creamery Cookie Dough Ice Cream due to rubber pieces found in two tubs. The product was distributed across eight western states.

    Product
    Red Button Vintage Creamery Cookie Dough Ice Cream, Net weight 1.75 qt (1.66 L).
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2265-2024·2024-07-10

    Abbott Liberta RC Pulse Generator Unexpectedly Shuts Down Periodically

    Abbott Liberta RC implantable pulse generators used for deep brain stimulation may unexpectedly turn off approximately every 50 days after activation, resulting in loss of therapy. Approximately 302 units have been recalled nationwide.

    Product
    Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2024·2024-07-10

    Prucka 3 Amplifier capacitors could fail during cardiac monitoring procedures

    Capacitors in Prucka 3 Amplifiers used with CardioLab and ComboLab cardiac systems could fail, causing display oscillations and preventing visualization of heart electrical activity waveforms.

    Product
    Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spare part #5875569 (Assy CLABIII AMP 128CH 100-240V 50-60HZ).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1460-2024·2024-07-10

    Breadman Jalapeno Cheese Bagels Recalled for Undeclared Milk Allergen

    Breadbox Co. is recalling Breadman Jalapeno Cheese Bagels (16 oz, expiration 5/21/24) distributed in Southern California due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    Breadman Jalapeno Cheese Bagels, plastic bag, 16oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2259-2024·2024-07-10

    Stryker Flyte Hood Protective Covers Recalled Due to Expired Products

    Stryker Corporation recalled Non-Sterile Flyte hood protective covers that were distributed expired. The affected medical device units may not function as intended.

    Product
    The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that the hood is securely tucked inside the gown. The hood attaches to and covers th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2024·2024-07-10

    X-ray cart positioning arm bolt may loosen and fall onto patient

    A bolt securing the positioning arm on First Source iQ Flex M X-ray carts may come loose and fall onto patients. The recall involves 137 units distributed across the US, Korea, and Serbia.

    Product
    First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2229-2024·2024-07-10

    Surgical Convenience Kits Recalled for Weak Seals Affecting Sterility

    Medline Industries recalls 7,673 surgical convenience kits due to weak Pure Pouch seals that may compromise sterility. Kits were distributed nationwide to healthcare facilities.

    Product
    Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2024·2024-07-10

    Medline Birthing Room Pack surgical kits recalled due to weak sterile seals

    Medline is recalling approximately 12,588 sterile surgical kits used for childbirth procedures because weak seals on Pure Pouch components may fail and compromise sterility.

    Product
    Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Sharp/Blunt Scissors 5.5", Reorder #65945 and containing a Pure Pouch component Sterile 5.5" Episiotomy Scissors, Reorder #67645.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1456-2024·2024-07-10

    Lactose Powder Recalled Due to Potential Salmonella Contamination

    Grande Ingredients has recalled lactose and lactose powder products due to potential Salmonella contamination. No illnesses have been reported.

    Product
    Drug Emporium Yogurt Flavored Pretzels, 8oz (227g) , GNS Foods, Arlington, TX 76011
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2239-2024·2024-07-10

    Avalon Ultrasound Transducers Recalled for Inaccurate Fetal Heart Rate Monitoring

    Philips is recalling Avalon ultrasound transducers used for monitoring fetal heart rate. The device may produce inaccurate measurements when monitoring multiple fetuses, potentially delaying detection of fetal distress.

    Product
    Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2024·2024-07-10

    Medline surgical convenience kits recalled for weak seal defects

    Medline Industries is recalling 12,588 sterile surgical convenience kits due to weak seals on Pure Pouch components that may breach sterility. Products were distributed nationwide across 23 states.

    Product
    Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. b. Medline Angiography Pack, Pack #DYNJ26488W, containing a Pure Pouch with compo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2024·2024-07-10

    Sterile surgical kits recalled due to weak pouch seals risking contamination

    Medline sterile surgical kits are being recalled nationwide due to weak seals in the Pure Pouch component that may allow sterility breach. The recall affects 12,588 units distributed across 23 states.

    Product
    Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2244-2024·2024-07-10

    MicroPort Knee Implant Recall: Wrong Size Component in Packaging

    MicroPort's EVOLUTION MP knee implants recalled due to one confirmed case where a Size 3 left-side component was packaged in a Size 4 right-side box. No injuries reported; distribution is limited to China with no U.S. inventory.

    Product
    EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1462-2024·2024-07-10

    Breadman Brioche Products Recalled for Undeclared Yellow No. 5

    Breadbox Co. is recalling Breadman Brioche products (Toast, Buns, Sliders, Hot Dog) distributed in Southern California due to undeclared Yellow No. 5, which may affect consumers sensitive to this color additive.

    Product
    Breadman Brioche products in plastic bags: Brioche Toast, 2 lb. (1 loaf/bag), Brioche Buns, 40oz (10 buns/bag), Brioche Sliders, 50oz (25 sliders/bag), Brioche Hot Dog, 40oz (10 buns/bag)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2261-2024·2024-07-10

    Stryker Corporation Recalls Expired Sterile Surgical Cannula Devices

    Stryker Corporation has recalled expired sterile cannula devices distributed nationwide. The devices were past their expiration date, potentially compromising sterility and device safety.

    Product
    This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0582-2024·2024-07-10

    Sun Pharmaceutical Recalls Decitabine Injection for Microbial Contamination

    Sun Pharmaceutical is recalling Decitabine for Injection (lot HAD2964A, 2,088 vials) for a Current Good Manufacturing Practice deviation. The Total Aerobic Microbial Count test on unfiltered bulk was out of specification; the product was distributed nationwide.

    Product
    Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2024·2024-07-10

    Beckman Coulter DxI 9000 Analyzer Tubing Malfunction Causes Test Errors

    Beckman Coulter DxI 9000 immunoassay analyzers may produce false or delayed test results due to pneumatic tubing disconnection during operation. Nine instruments are affected across the US and Europe.

    Product
    Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human bod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2024·2024-07-10

    Siemens ARTIS Angiography Systems Recalled for Excessive Radiation Dose

    Siemens is recalling ARTIS angiography systems where the first X-ray after patient registration may use incorrect copper prefiltration, potentially resulting in higher radiation doses than intended.

    Product
    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2226-2024·2024-07-10

    Medline Neuro IR Surgical Kit Recalled Due to Weak Seals

    Medline is recalling Neuro IR surgical convenience kits due to weak seals in the Pure Pouch component that may compromise sterility. The recall affects 12,588 kits distributed nationwide.

    Product
    Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide